pda.

org/EU/UPS2019

2019 PDA EUROPE

The Universe of Pre-filled Syringes
and Injection Devices
Advancing Drug Delivery Systems to Improve Patients’ Lives

22-23 OCTOBER 2019

GOTHENBURG, SWEDEN
PRE-CONFERENCE WORKSHOPS: 21 OCTOBER
CONFERENCE & EXHIBITION: 22-23 OCTOBER
TRAINING COURSES: 24-25 OCTOBER
 WELCOME FROM THE CHAIRS

Dear Colleagues,
Scientific Program Planning Committee
The Parenteral Drug Association warmly invites you to come
Thomas Schoenknecht, LONZA, Chair and be part of this year’s Universe of Pre-filled Syringes and
Mathias Romacker, Pfizer, Chair Injection Devices, for the first time in Sweden!
Frank Bamberg, CSL Behring
Since its first edition in 2004, the conference has become a
Theresa Bankston, Becton Dickinson
fixture in the calendar for the pharmaceutical industry and
Markus Bauss, SHL Connect a must-attend event for everyone working in the fields of
Sherri Biondi, AstraZeneca parenteral drugs and device development.
Nicolas Brandes, WEST
For its 16th year, the European event ventures out to the north of
William Dierick, Terumo
Europe to Gothenburg, Sweden. This amazing city is located at
Olivia Henderson, Amgen a key strategic location where river meets the sea.
Laurent Jeanmart, GSK
Philippe Lauwers, Terumo With its Dutch heritage, Gothenburg perfectly combines tradition
and innovation, offering an overwhelming cultural diversity of the
Manfred Maeder, Novartis
arts and the sciences.
Hanns-Christian Mahler, LONZA
Alessandro Morandotti, OMPI - Stevanato Group Geographically situated in the center of Scandinavia with the
Brigitte Reutter-Haerle, Vetter largest port of that region, traditionally, trade, manufacturing,
and industry have been the main contributors to the city’s
Thomas Seiffer, Bausch + Stroebel
wealth.
Ian Thompson, Ypsomed
Karthik Vaideeswaran, Eli Lilly This signature PDA event will expose you to the vast net of the
Falk Klar, PDA Europe PDA family, a culturally and scientifically diverse melting pot.
Coming to Gothenburg will offer you close to unlimited potential
Sylvia Becker, Senior Manager Programs & Events,
PDA Europe for identifying new business partners, meet fellow professionals,
connect with international colleagues, and simply make new
friends!

PDA has made every effort to create yet another impressive opportunity for you to gain access to key decision
makers in the pharmaceutical industry. Meet government representatives, service providers, and manufacturers
from all over the world this fall!

Join us in Gothenburg and be part of the world’s largest event on this subject.

Sincerely,
The Chairs

Mathias Romacker, PhD, Thomas Schoenknecht, PhD,

Pfizer LONZA

2 pda.org/EU/UPS2019
WELCOME TO
GOTHENBURG
S C H E D U L E AT A G L A N C E

21 October 10:00 – 17:00 Innovating the Journey from Workshop

Manufacturing to the Patient

21 October 10:00 – 17:00 Innovative Drug Delivery Sytems / Workshop

Combination Products

21 October 10:00 – 17:00 Impact of Pre-Filled Syringe Workshop

Components on Biopharmaceuticals

21 October 19:30 – 22:30 Welcome Party by TERUMO

22 October 9:00 – 18:00 The Universe of Pre-filled Syringes and Conference, Exhibition
Injection Devices

22 October 19:30-22:00 Networking Event

23 October 9:00 – 16:30 The Universe of Pre-filled Syringes and Conference, Exhibition
Injection Devices

24 October 9:00 – 17:30 All About Pre-filled Syringe Training Course

25 October 9:00 – 15:45 Systems - From Initial
Development to Final Fill Finish

24 October 9:00 – 17:30 Container Closure Training Course

25 October 8:30 – 16:30 Integrity Testing

24 October 9:00 – 17:45 Test Methods for Pre-Filled Training Course

25 October 9:00 – 15:30 Syringe Systems

24 October 9:00 – 18:00 Extractables and Leachables Training Course

25 October 9:00 – 16:30

For latest information, please visit: pda.org/EU/UPS2019

Media Partners

pda.org/EU/UPS2019 3
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21 OCTOBER 2019
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 PRE-CONFERENCE WORKSHOP

Innovating the Journey from

Manufacturing to the Patient
Creating the Internet of Health

Workshop Description
In the past years the development of computer technologies and electronics has undergone significant
changes. New products and services have begun to establish in different fields of the industry.

But how will the newly gained knowledge and the associated opportunities transfer to the conservative
pharma industry? How will the manufacturing process itself, the supply chain as a whole or the patient
usability of the product change under this influence?

Currently a change in thinking seems to be taking place in our industry, specifically with regard to the
use of smart data, machine learning and wireless connectivity. It has become increasingly indispensable
for companies to provide expertise in these areas. Simultaneously the technological advancements
are reflected in novel regulatory guidelines, for example in the area of serialization. Additionally, digital
platforms providing therapy support to patients are on the rise, involving wearables and connected drug
delivery devices systems.

Yet technology alone is not sufficient – value is added only by implementing practical applications and
solutions making strong partnerships between pharmaceutical companies and technology providers
essential to ensure the desired progress.

Beginning with an overview on serialization activities and experiences regarding the implementation of the
recent EU-initiative, different applications within the wide field of the Internet of Health will be presented.
This includes the manufacturing process, Fill-and-Finish as well as the integration of new technologies in
medical devices and packaging.

The second part of the event will focus on how our industy can better meet patient requirements and on
the challenges they are confronted with in different situations of their day-to-day use.

Markus Bauss, SHL Connect, Workshop Chair

Markus has over 10 years’ experience in the area of pharmaceutical packaging in various leading roles such as
global key account management, research & innovation and business development. Looking at upcoming new
technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up com-
pany ConnectMeSmart GmbH in 2013. In 2015, SHL Group and ConnectMeSmart partnered up in the Joint Ven-
ture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential
application within each of SHL Group’s companies. From 2004 to 2014, Markus was working for Schreiner Medi-
Pharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, Markus contributed
with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. Markus studied
process engineering at the Technical University of Clausthal and started his career in environmental & recycling
technology at RWE in Germany in 1997, prior to moving to the pharmaceutical area.

8 pda.org/eu-ups/IJ19
 AGENDA

9 Oct 2019

Monday, 21 October 2019

10:00 Welcome and Introduction Markus Bauss, SHL Connect

Serialization Initiatives and the Implementation of the EU Directive

10:10 • Overview of Current Serialization Activities Dieter Moessner,

• Experiences with the Implementation of the Recent EU Directive Edelmann Group

10:35 Technical Challenges for Pharma Manufactures and Future Outlook Yves Steffen, Novartis

11:00 Coffee Break & Exhibition

11:30 The Transparent Process – SmartSkin Technologies in Fill-and-Finish Brian Coon,

Smart Skin Technologies

11:50 Innovating the Manufacturing Process from the Perspective of Thomas Seiffer,
Machine Manufactures Bausch + Stroebel

12:10 RFID Applications in Healthcare and their Value Markus Bauss, SHL Connect

12:30 Q&A, Discussion

12:45 Lunch Break & Exhibition

How the Industry Can Better Meet Patients Requirements

In three small groups, attendees will have the chance to hear patients share their experience with current administration
options and novel technologies in an intimate and realistic setting. In the meantime, poster presentations and updates on the
most recent device innovations will deepen the understanding of how our industry can better meet patient needs.

13:45 Introduction to the Patient Experience Room Sherri Biondi, AstraZeneca

GROUP 1 GROUP 2 GROUP 3

13:55 Patient Experience Room Poster Presentation Device Innovations

14:20 Device Innovations Patient Experience Room Poster Presentation

14:45 Poster Presentation Device Innovations Patient Experience Room

15:10 Coffee Break & Exhibition

15:40 Smart Blister Technology – From Concept to Scaled-up Production Uwe Braun,
Schreiner Medipharm

16:05 Improving Patient Engagement Through the Use of Digital Products Bob Scrase, Phillips Medisize

16:30 Panel Discussion

17:00 Summary of Pre-Conference Workshop and Farewell Markus Bauss, SHL Connect

Program is subject to change without notice, all speakers pending confirmation

pda.org/eu-ups/IJ19 9
 PRE-CONFERENCE WORKSHOP

Innovative Drug Delivery Systems/

Combination Products
Risk Management and the New European Medical Devices Regulation

Workshop Description
The Workshop will focus on Risk Management and the New European Medical Devices Regulation (EMDR)
and the challenges associated with the practical implementations.

Learn from suppliers’ latest solutions and hear guest speakers and industry experts share an outlook
on what to expect with the implementation of the new EMDR and specific requirements for combination
products. Interact with other participants and speakers during round table discussions and exchange on
all issues vital for the success of your product. Interactive Group exercises will ensure conclusive and
practical take-home-messages for the participants.

Who Should Attend

The target audience for this workshop is from departments like Device Development, Compliance, Opera-
tions, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Busi-
ness Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Control,
Clinical Affairs.

Learning Objectives
Upon participation of this workshop you will be able to:
• Learn about the latest trends in commercialization of different devices such as inhalation products,
patch infusers or large volume injectors
• Understand the specific requirements for clinical trials, surveillance and classification of devices under
the New European Medical Devices Regulation
• Understand the core principles and requirements for risk management of combination products

Thomas P. Schoenknecht, LONZA, Workshop Chair

Thomas Schoenknecht has over 20 years’ experience in the pharmaceutical industry in various leading roles such
as project management, research & development and business development. Before joining LONZA in 2019 as
Head of Research and Development DrugProductServices, Thomas has been with SHL since 2013 as an Executive
Director of Business Development, responsible for global Business Development, Key Account Management and
new Technology Evaluation, Thomas has gained experience in various leading positions in product and business
development at Schott Pharmaceutical Packing Division, Amgen Inc California and Gerresheimer’s Pharmaceu-
tical Packing Division. Thomas has a Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the Uni­
versity Goettingen, Germany and a Master’s degree in Chemistry from the University Goettingen.

10 pda.org/eu-ups/DDSCP19
 AGENDA

9 Oct 2019

Monday, 21 October 2019

10:00 Welcome and Introduction Thomas Schoenknecht, LONZA

10:10 Latest Trends in Device Commercialization of Thomas Schoenknecht, LONZA

Parenteral Applications
• Patch Infusers/Large Volume Injections
• Adherence Systems/Technologies

Risk Management Moderator: Alphons Fakler, Novartis

10:40 Risk Management for Combination Products - Alphons Fakler, Novartis

Specific Requirements for Combination Products

11:10 Coffee Break & Exhibition

11:40 Risk Management Exercise: Group Activity

• Core principles in risk management: severity, occurrence,
harm and hazard
• Typical hazards with injection devices
• Definition of occurrence of harm

12:15 Round Table Discussion

13:00 Lunch Break & Exhibition

New European Medical Devices Regulation Moderator: Michael Karl Ledinegg, Sandoz

14:00 An Introduction to the New European Medical Devices Regulation Michael Karl Ledinegg, Sandoz
and the Consequences for Combination Products - General
Overview and Timelines
• EMDR product related aspects
• EMDR system related aspects
• Identification of products

14:30 Round Table Discussion

• Single Integral Drug Device Combinations under Article 117
• Co-Packed Drug Device Combinations

15:15 Coffee Break & Exhibition

Closing Moderator: Thomas Schoenknecht, LONZA

15:45 Summary of Roundtable Discussions Alphons Fakler, Novartis

Michael Karl Ledinegg, Sandoz
Thomas Schoenknecht, LONZA

16:00 Supplier presentations

• Interactions with customers
• Tech Transfer
• Case Studies
• Latest trends in specialized devices

16:50 Q&A and Final Discussion

17:00 Summary of Pre-Conference Workshop and Farewell Thomas Schoenknecht, LONZA

Program is subject to change without notice, all speakers pending confirmation

pda.org/eu-ups/DDSCP19 11
 PRE-CONFERENCE WORKSHOP

Impact of Pre-filled Syringe

Components on Biopharmaceuticals
Workshop Description
Biotherapeutics remain the largest growing segment in the pharmaceutical industry, spurred by various
technological advancements in many fields and with further progress in understanding diseases. Moreover,
advanced therapy medicinal products (ATMPs) offer ground-breaking new opportunities for the treatment
of currently untreatable diseases or provide for additional effective and curative treatment options.

These advances in pharmacotherapy are also giving challenges and hurdles, with regulators becoming
increasingly stringent. It is critical to consider potential interactions with primary packaging components
and direct contact materials. The importance of Pre-filled syringes and other Pre-filled drug containers,
often used in combination with drug delivery devices, cannot be underestimated within this space of
parenteral drug delivery.

This workshop will address various aspects regarding potential influences from primary packaging
components and materials on drug quality, safety and efficacy, including the influence of sub-visible
particles, extractables and leachables, silicone oil, handling and manipulation, e.g. aggregation, protein
degradation routes and stability.

This workshop will bring together experts from academia, the pharmaceutical industry and providers
of primary packaging components to share their experiences. There will be plenty of time allocated for
discussion and interaction with the audience.

Who Should Attend

Professionals involved in research, development and manufacturing of biopharmaceuticals, primary drug
container and parenteral drug device development, quality and regulatory.

Philippe Lauwers, Director, Technology Development Terumo Pharmaceutical Solutions

Philippe graduated in Biotechnology from the Ghent University, Belgium, and worked as a scientific researcher
at the Catholic University of Leuven, Belgium. Upon obtaining an additional degree in Biomedical Engineering, he
moved from an academic to an industrial environment. He has been active in the medical device and pharmaceu-
tical packaging sector for the last ten years with growing responsibilities in business development and technical
roles. Philippe also serves as expert in ISO technical committees TC76 and TC84.

12 pda.org/eu-ups/IPSB19
 AGENDA

9 Oct 2019

Monday, 21 October 2019

10:00 Welcome: Opening Remarks & Introductions Philippe Lauwers, Terumo

Opening Plenary: Keynote Presentations

10:15 Formulation and Primary Packaging Optimizations for Susumu Uchiyama,

Biopharmaceuticals in Pre-filled Syringes Osaka University

10:45 Interactive Group Discussion – Creating a Mind Map Roman Mathaes, LONZA

11:15 Coffee Break & Exhibition

11:45 Primary Packaging Material: One of Several Suspects Causing Guenter Waxenecker,
Immunogenicity BASG, Austrian Agency for
Health and Food Safety

12:15 Interactive Group Discussion – Creating a Mind Map Roman Mathaes, LONZA

12:45 Lunch Break & Exhibition

Interactions between Primary Packaging Components,

Drug Product Formulation and Functionality

13:45 Influence of Surface Treatment on Migrating Components Simon Kervyn, Datwyler

from the Elastomeric Closure

14:15 Using Drug Container Interaction Screening Methods Robert Hormes, Novartis
to Design a Robust Syringe - Autoinjector Functionality

14:45 Interactive Group Discussion - Creating a Mind Map Roman Mathaes, LONZA

15:15 Coffee Break & Exhibition

15:45 Extractables & Leachables: Chemical Interactions Between Leach- Koen Nuyts, Nelson Labs
ables and Biopharmaceuticals

16:10 Polysorbate – a Relevant Excipient for Biopharmaceuticals Andrea Hawe, Coriolis Pharma
in Pre-filled Syringes

16:35 Finalizing the Mind Map and Workshop Summary Roman Mathaes, LONZA
Philippe Lauwers, Terumo

17:00 End of Workshop and Farewell Philippe Lauwers, Terumo

pda.org/eu-ups/IPSB19 13
 CONFERENCE AGENDA

9 Oct 2019

Tuesday, 22 October 2019

9:00 Welcome: Opening Remarks & Introduction Falk Klar, PDA Europe

PDA Awards Conference Chairs

Thomas Schoenknecht, LONZA
Mathias Romacker, Pfizer

Opening Plenary Moderators: Thomas Schoenknecht, LONZA

Mathias Romacker, Pfizer

KEYNOTE PRESENTATIONS - Regulatory & Technology Highlights

9:30 Digital Health: Design for the Behaviour You Would Like to See Julia Häring, Novo Nordisk

9:55 Drug-Device Combinations in the EU: An Update Pascal Venneugues,

European Medicines Agency

10:20 Challenges and Opportunities of Developing a Dennis Lee, Gates Foundation &
Self-Injectable Platform for Global Health Applications Robin Hwang, ICP Consulting

10:45 Coffee Break, Poster Session & Exhibition

11:30 Delivery Device Development in Midst of an Evolving Landscape of Andrew Ratz, Eli Lilly
Novel Drug Modalities, Patient Centered Design and Digital Health

11:55 Life-Cycle Management of Combination Products Juan C. Kuang, Amgen

12:20 Panel Discussion, Q&A

13:00 Lunch Break, Poster Session & Exhibition

TRANSITION TO PARALLEL TRACKS

PARALLEL TRACKS ABC

Session 1 TRACK A TRACK B TRACK C

Human Factors Polymer Containers Regulatory Perspectives

Moderator:
Sherri Biondi, AstraZeneca
14:30 Larger Injection Volumes,
Longer Injection Times – Where
are the Users’ Limits with
Handheld Devices?
Moderator:
William Dierick, Terumo
Business Case and Journey of
Launching a Biosimilar
in a Polymer Prefilled Syringe in
the International Market
Moderator:
Olivia Henderson, Amgen
An Opportunity to Leverage
the Medical Devices Regula-
tion (MDR) Whilst Supporting
a Broad Innovative Portfolio in
Pharma

Jakob Lange, Ypsomed Yoshifumi Torii, Daniel Latham, Novartis &

14:50 Practical Pathways for Human
Factors Regulatory Compliance
for Parenteral Products
Fujifilm Kyowa Kirin Biologics Co.
Polymer Prefilled Syringes and
Cartridges - Process Technol-
ogy Development and Handling
Aspects for Successful Fill-
And-Finish
Mark Chipperfield, Corvus Device
Impact of MDR Article 117 on
Marketing Authorization Appli-
cations for Pre-filled Syringes

Bjorg Hunter, GSK Philipp Hoerner, Stephanie Horn,

Bausch + Stroebel F. Hoffmann-La Roche

14 pda.org/EU/UPS2019
 CONFERENCE AGENDA

15:10 Human Factors Perspectives on Excipients Effects on Func- MDR Article 117: Notified Body
Leveraging a Platform Tech­ tionality of Glass and Polymer Opinion Interpretation and
nology Based Pre-filled Syringes Implementation

Nicholas Stones, Novartis Liang Fang, WEST Blake Green, Amgen

15:30 Q&A, Discussion Q&A, Discussion Q&A, Discussion

16:00 Coffee Break, Poster Session & Exhibition

TRANSITION TO PARALLEL TRACKS

PARALLEL TRACKS ABC

Session 2 TRACK A TRACK B TRACK C

Large Volume Injection Manufacturing and Novel Therapeutics

Moderator:
Ian Thompson, Ypsomed
16:45 MRI Clinical Imaging of Human
Subcutaneous Injections Up to
10ml in the Abdomen, Thigh
and Arm
Processing Technologies
Moderators:
Laurent Jeanmart, GSK
Hanns-Christian Mahler, LONZA
Innovations in Manufacturing
of Elastomeric Components for
Parenteral Packaging Applica-
tions
Moderator:
Manfred Maeder, Novartis
Design Considerations Pertain-
ing to Primary Container Used
for Cell Therapy Products

Wendy D Woodley, Rahul Thakar, Min Wei, AstraZeneca

Becton Dickinson Datwyler Sealing Solutions
17:05 Evaluating Formulation and Augmented Reality for A Science-Based Recommen-
Device Factors on Subcutane- Preventive Maintenance dation of Elastomer Compo-
ous Administration nents for Biologic Drugs

Rhea Sirkar, Eli Lilly
17:25 Evolving Component Technol-
ogies to Meet the Needs of
Cartridge Delivery Applications
Michael Pratz, Bausch & Stroebel
Vision Robot Unit (VRU)
Cathy Zhao, WEST
Challenges & Device Opportuni-
ties with Microliter Dose
Delivery Using Standard
Pre-fillable Syringes:
A Case Study

Simon Cote & Royce C. Brockett, Michael Betz, Gautam Shetty,

WEST F. Hoffmann-La Roche Congruence Medical Solutions &
Andrea Sardella, Stevanato Group Kedar Datar, Boehringer Ingelheim
17:45 Q&A, Discussion Q&A, Discussion Q&A, Discussion

18:00 End of Day 1 & Networking Event

Program subject to change without prior notice - for most current updates, go to pda.org/EU/UPS2019

pda.org/EU/UPS2019 15
 The Parenteral Drug Association warmly invites you to an evening of
Networking, Dinner & Dance.

Relax, Chat, and Dance the Night Away With PDA!

22 October 2019 • 19:30h - 22:00h

Teatergatan at Valand
Vasagatan 41
411 36 Gothenburg
Location Within a Short Walking Distance from the Conference Venue

DRESS CODE: 1970s Disco Attire

Admission is included in the Conference Registration.
To reserve your ticket, please register online.
 CONFERENCE AGENDA

Wednesday, 23 October 2019

Morning Plenary Moderator: Mathias Romacker, Pfizer

KEYNOTE PRESENTATIONS - Patient & Payers Perspectives

9:00 Patient Perspective of Managing Type 1 Diabetes in the Digital Age Johan Ahstrom, Patient Speaker

9:25 The Evolving Payer Perspective on Injection Treatment Devices: Robert S. Epstein, Epstein Health
Balancing Costs, Convenience, Outcomes and More

9:50 Unsolved Mystery: John Alter, Pfizer,

How to Get Payers to Reward Injection Device Innovation Every Time

10:15 Panel Discussion Moderator: Max Cambras, LEK

Partnering with Payers and Health Systems to
Support Digital Innovation in Drug Delivery Devices

10:45 Coffee Break, Poster Session & Exhibition

PARALLEL TRACKS ABC

Session 3 TRACK A TRACK B TRACK C

Digital Health & Manufacturing and Development Strategies

Connected Devices Processing Technologies
Moderator: Moderators:
Markus Bauss, SHL Connect Theresa Bankston, BD
Philippe Lauwers, Terumo
11:30 Digital Health Application Case Study:
Development Within a Pharma- Modular Scalability & Flexibil-
ceutical Culture ity in Device Assembly - From
Early Stage to Full Scale
Production
Moderator:
Brigitte Reutter-Haerle, Vetter
Collaboration to Enable a
Simple, Reliable Device Suit-
able for Self-Administration in
Early Clinical Studies Through
to Commercialization

Gareth Hilton, AstraZeneca
11:50 A Behavioural Design Approach
to Digital Health Solutions
Jens Schou Christensen,
Stevanato Group
Modularizing Assembly and
Testing Equipment for Auto and
Pen Injectors
Nicolas Bralet, Becton Dickinson
& Peter Krulevitch, Janssen
Creating a Parenteral Drug
Delivery Device for Developing
Markets

Geraint Davies, Gilbert Fluetsch & Lucy Chung, Rob Veasey,

F. Hoffmann-La Roche
12:10 To Connect or Not to Connect:
When Should A Parenteral
Device Go Connected?
SHL Group
Seeing the Hidden: Detection
of Leakage in Pre-filled Syringe
During Storage by Neutron
Radiography
DCA Design International &
Stefan Bohling, Sanofi Aventis
Software and Services to
Transform Drugs into Disease
Management Solutions

Paul Greenhalgh, Jonas Fransson, Alexander Dahmani,

TeamConsulting Swedish Orphan Biovitrum QuiO Technologies
12:30 Q&A, Discussion Q&A, Discussion Q&A, Discussion

13:00 Lunch Break, Poster Session & Exhibition

pda.org/EU/UPS2019 17
CONFERENCE AGENDA

Closing Plenary - Keynotes Moderators: Mathias Romacker, Pfizer

Thomas Schoenknecht, LONZA

14:20 Formulation and Device Lifecycle Management – Beate Bittner,

The Role of Drug Delivery Devices in F. Hoffmann-La Roche
Improving Access to Medicines

14:45 A Novel Approach to Characterizing Roman Mathaes, LONZA

Drug Delivery System Flow Performance

15:10 Coffee Break, Poster Session & Exhibition

15:40 Closing Panel Discussion, Q&A

16:10 Conference Summary by the 2019 Co-Chairs Thomas Schoenknecht, LONZA

Mathias Romacker, Pfizer

16:30 Closing Comments & Farewell Falk Klar, PDA Europe

Program subject to change without prior notice - for most current updates, go to pda.org/EU/UPS2019

IMPROVING PATIENTS’ LIVES

THROUGH OUR INNOVATIVE
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People are different and
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 i
per
Dra

Congress Foyer
N
R ATIO
I ST
REG

Branddörr
Vattenautomat

H5A

Track B
Skyliftgarage
Plenary Congress Hall

Pers.ingång
(Får ej blockeras)

Room G1 & G2
Working
Lounge

H Track A
H1A H2A

Entrance Innovation Laboratory

H3A H4A
Room H1 & H2

Hall of
H6A
Gothenburg Fame
Patient Convention
Experience Bureau
Pavilion

Stage

Diamond
Junction
Disk

Company Name Booth Company Name Booth Company Name Booth Company Name Booth

3P Innovation Lab F20 Cambridge Consulants F80 DCA Design HK Packaging Consulting
F56, F48 H6A
International GmbH
Automationspartner AB F05 Cambridge Design F19
Partnership Duojet Medical IGS Geb Jagema F65
F75
ATS Automation F08 Systems
Catalent F109, F110 IMA F28, F29
Aptar F72 E3D F85
Clariant Plastic & Coatings Innerspace H5A
F55
Baumann Medical F26 GmbH ELIX Polymers SL F87
Insight Product F11
0

Bausch & Ströbel Congruence Medical Inno Enable Injections F13 Development
1 25

H1A
/ WILCO / Harro F93, F94 Solutions Lab
Höfliger Flex F41, F42 Kahle F62
Kaffebuffé

Connecticut Spring & F30

Battelle F111 Stamping Fresenius Kabi Austria Körber Medipark Systems F12
F86
1 50

GmbH
0
Höjd=2,30 m
Arrangé

BD F33, F24, F25 Consort Medical / Lighthouse F64

F70, F73
0
Bespak Europe LTD Früh Verpackungen F95
F102 Lonstroff AG F07
1 50

Välkomstdisk
Biocorp Inno Lab F103 Copernicus F78 Gerresheimer F91
H4A Lonza Pharma & Biotech F50
CREDENCE F63 Getinge G01
B.Braun Melsungen AG F84
Arrangé

Lyophilization
Arrangé

Dali F79 InnoLab H2A

Gore G5, G10 Technology Inc
WC DAM Brevetti Angela F104
Datwyler F43 Heuft Systemtechnik G16 Medical Engineering F106
Disk

WC HERR COMECER F09 Technologies

Disk
Disk

HWC
CR

Water Cooler

Ståbord Ståbord Ståbord Ståbord

Ståbord Ståbord Ståbord Ståbord Ståbord Ståbord

Bo
rd
Bo

Bo
Re

rd

rd
ce
pti
on

EXHIBITION
Bo
rd
Bo

Bo
rd

rd
Ta
ksk
en
a

Serveringsdisk

Serveringsdisk

Bo
rd

Entrance
FLOOR PLAN Hotel
Gothia
ance 5 Water Cooler

Towers

22 pda.org/EU/UPS2019
 01 02
Working 13 14 15 16

03
Lounge

Bo
rd

Bo
rd
Bo
rd
Track C 12
CATERING 04 05 06 07

G
2 Room G3 11
10 11 12 13 08 09
Happy
Hour
Bar 14 15
Posters 01 02 03 04 05
06 07 08 09 10
Pall Pall Pall Pall

16 17 18 19 20 2122 23
Posters
Bord Bord Bord Bord

Soffbänk Soffbänk Soffbänk Soffbänk

24 25 26 27 28 29 30 31 32

33 34 35 36 37 38 39 40

41

CATERING

Catering

Catering

Catering

Catering
42

43

Company Name Booth Company Name Booth Company Name Booth

44 45 46 47 48 49 50
Mikron F101 Raumedic F81 Sonceboz F53

Mitsubishi Gas Robert Bosch Packaging Sorrel Medical F06 5152 53 54 55 56 5758
F100 F58
Chemical Company Technology
Steriline F40 5960 61A 61B
Nelson Labs F105 F. Hoffmann - Diamond 62

F
La Roche Junction Sterisys G04
Nemera F107
Rommelag F99 Stevanato Group F36, F37 6364 65
Neoceram S.A. F88
ROVI Team Consulting F61B 66 67 6869
Nipro G08 + G09 Contract Manufacturing F52 70
Terumo F38, F39
Noble F16 Sartorius F21 71 72 Networking
Topas Advenced Polymers G11 Lounge 73
Nolato Medical Solutions F89 Scherdel F10
Transcoject GmbH G03 74 75 76
On Drug Delivery F32 Schoettli F97
TTP G02
One World F74 Schott F59, F60 77 78 79 8081
82
Unchained Labs F96
OPTIMA F14 Sensile Medical F92
Vetter F49, F57 83 84 85 86 87
Owen Mumford F34, F35 Schreiner Medipharm F17, F18
Wihelm Haselmeier F83 8990 91 92 93 94 9596
PDA Lounge F113 SHL F45, F46, F47 88 97
West F44
PHC F77 Shore Group F98 Pharmaceutical InnoLab F51 9899 100 101 102 103
Services H3A 104
Phillips Medizise F66,F67 Sio2Med F27
Ypsomed G13, G14, G15
105 106
Bo

Pia Automation Skan AG F108

rd

F04
Bo
rd

Amberg GmbH Zebrasci G06

Bo
rd

Smart Skin F59, F60

Plas-Tec-Engineering F61A Technologies Zeon F54

PTI F90 SMC F68, F69 Zwick Roell F01 107 108
CATERING

Smithers F71 109110 111 112

Innovation Laboratory Networking Lounge PDA

Lounge 114
Sponsor Working Lounge
115 116 117 118
F. Hoffmann-La Roche Happy Hour Bar
Diamond Junction Working
Lounge
Catering Area
Poster Session
AstraZeneca & Matchstick
PDA Lounge Patience Experience Pavilion

pda.org/EU/UPS2019 23
 SCIENTIFIC POSTER SESSION

Please visit our poster presenters during the breaks:

POS. POSTER TITLE COMPANY
PRESENTER

1 Dirk Gläser Combination Product Lifecycle Management Case Study: F.Hoffmann-La Roche
Introduction of a New Therapeutic Indication Ltd,

2 Tomohiro Suzuki EXYCAPT_ Multilayer Plastic Vial & Syringe Mitsubishi Gas Chemical
Company, Inc

3 Karin Fischer Gx InnoSafe, Integrated and Passive Safety Systems Gerresheimer

4 John Simpson Integrating Human Factors Into the Product Development Process – BD
Development of BD Intevia™ 1 Ml Two-Step Disposable

5 Sivan Koskas 8 mm Needle - a First Step to Improve Chronic Subcutaneous Drug BD

Delivery

6 Megan Lan Enabling Biologic Drug Delivery of Volumes Beyond 1 ml With BD

Ergonomic Injection Solutions for Targeted User Populations

7 Joe Reynolds Enhancing the Patient Experience for Self-Injection Systems BD

8 Christopher J Rini Impact of PFS Needle Dimensions on High Volume, High Viscosity BD
Fluid Delivery

9 Natasha G Bolick Imaging Large Volume Subcutaneous Injections in Swine and BD

Human Models Informs Effective Clinical Design

10 Lionel Maritan A Successful System Integration Enables Robust and Well BD

Designed Autoinjector-Based Combination Products

11 Ashton Gwinnell Evaluation of Syringe Configurations for the Delivery of AstraZeneca

Viscous Formulations in a Pharmacokinetics Study

12 Christopher Customization of Fluids & Gels for Motion Control & Simulation in NYE
Andreola Parental Drug Delivery

13 Dhananjay Jere Formulation Parameters On Intravitreal Dosing Accuracy Using 1mL Lonza
Commercial Syringes

14 Christian Riva Analysis and Simulation of Injection Volume Accuracy in On-Body Flex
Delivery Systems

15 Saki Yoneda Establishment of a New Quantification Method for Protein Osaka University
Aggregates in Biopharmaceuticals

16 Tim Allen Device Drive Technology Considerations for Large Volume Drug West
Delivery

17 Dr. Caroline Case Study QC-Lab Implementation and Performance of Vetter

Peskoller Autoinjector Release Testing

18 Chava Hadany Utilizing Connected Drug Delivery Devices for Patient Adherence to DALI Medical
LAI-AP Treatment

19 Lisa Krapf The New Hound: Three Lasers to ID It All Unchained Labs

24 pda.org/EU/UPS2019
 SCIENTIFIC POSTER SESSION

20 Tyler Hinkle Novel Test Method to Assess Consistency of Autoinjection W.L. Gore

21 Simon Kervyn Influence of Water Content of Combiseals Bulging Datwyler

22 Arne Rehm RFID Labeling Solutions for Injection Devices and Pre-filled Syringes Schreiner MediPharm
Challenges, Solutions and Benefits in Real World Applications

23 Sivan Koskas Evaluating The Impact Of Sterilization MethodsOn Stopper Aptar Pharma & BD
Performances

24 Gautam Shetty Accurate, Precise, Microliter Vial Transfer & Delivery Congruence Med.

25 Manuela Basso Phase Change Material (PCM) for Drug Injection Warming Nemera

26 Chris Hurlstone Regulatory Approval of Medical Devices – What Is Good to Know? Team Consulting

27 Stephen Augustyn How to Design a Body Worn Injector Team Consulting

28 Paolo Liverani Integrity Testers for Isolator Gloves and the DPTE® Aseptic Getinge
Transfer System

29 Christopher Oxidative Stability of Biologics Packaged in Sterilized SiOPlasTM SiO2 Medical Products,
Weikart Primary Containers Inc.

30 Dr.-Ing. Manufacturing of Injectable Implants for Drug Delivery Thermo Fisher Scientific
Margarethe Richter,
Anja Geissler-Fichtner

2019 PDA Drug Delivery Innovation Awards

Category 1
Innovation - Recognizing a new device, manufacturing
process, method, or
automation that brings value to the industry

Category 2
Partnership Innovation (supplier and pharma/
biotech) – Recognizing achievement in partnering
to successfully launch or introduce a new
product to the market or modifying an existing
product to make it significantly better or
scalable

PDA is pleased to introduce the new PDA Drug Delivery Innovation Awards, created to recognize technical innovation
advancing the field of bio/pharmaceutical manufacturing. Winners will be acknowledged and awards will be presented
during the 2019 Universe of Pre-Filled Syringes and Injection Devices.
 TWO-DAY TRAINING COURSE

All about Pre-filled Syringe Systems

From Initial Development to Final Fill Finish
Overview
Join us on our journey from the components of a syringe to a customer needs oriented pre-filled syringe system. This two-day interac-
tive course will provide an overview of relevant practical aspects and trends of developing and processing of pre-filled syringes. It will
also address relevant regulatory requirements related to materials, components and processes of pre-filled syringes. Special focus is
given to the perspectives of health care practitioners and patients covering the relationships of syringe properties with aspects of drug
administration. In hands-on sessions participants will have the opportunity to study pieces of equipment such as syringes, stoppers,
needle shields and tip caps in more detail. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art
technology. Discussions of real case examples and Q&A sessions will complement the course.

Who Should Attend

• Packaging engineers with little or no experience in Pre-filled syringes
• Pharmacists and formulation developers who want to learn about prefilled syringes as a device
• Quality, Purchasing, Business Development, Sales

Learning Objectives
Upon completion of the course participants
• Know the stakeholders in Pre-fillable and Pre-filled syringes
• Understand what the packaging supplier can support with and what can only be done at the pharma company
• Understand Pre-filled syringe technologies, materials, applications and requirements
• Are able to develop a syringe system that fits the needs of a dedicated application
• Are able to compare different syringe types with regard to their advantages and disadvantages

Michael Andersen, Sales Director, Bosch Packaging Scandinavia

Michael Andersen has a mechanical engineering degree, and an MBA from SDU in Denmark. The start of his career was
in mechanical design, moving on to project management and sales. In August 2015 he joined Bosch Packaging at the
Danish site in Sandved, manufacturing assembly and handling machines, especially within the device market. He has
been a driving force developing the company within the device market, latest with the highly successful Range-Program
for devices assembly, labelling and pack- globally. Recently he has also picked up the commercial responsibility for the
full portfolio of Bosch Packaging within the pharma industry. Michael’s position covers the Business Development and
conceptualizing of machines and systems.

Christa Jansen-Otten, Director Global Product Management Prefilled Systems and Delivery, West
Since 2016 Christa holds her position as Director of Global Product Management, Prefilled Systems and Delivery, at West
Pharmaceutical Services, Inc. She has worked within the pharmaceutical industry for more than 20 years. Christa gained
experience as Quality Assurance Manager in one of the world’s leading pharmaceutical companies for sterile filling and
packaging. In addition, she spent several years with the leading pre-fillable syringe manufacturer in the Customer Quality
Assurance department. She joined West in 2005 and developed an expertise in pre-filable systems and delivery technol-
ogy in the Technical Customer Service and Marketing departments. Christa holds a diploma in Biomedical Engineering
from the University of Aachen.

Klaus Ullherr, Senior Product Manager, Robert Bosch Packaging

Klaus Ullherr has a degree in electrical engineering. After university, he worked for several years as a project manager in
the electrical industry. In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma
Liquid. During the first two years, he was responsible for handling complex customer orders. Since 2002, he is product
manager for the business fields syringes and filling systems with global product responsibility. His main responsibilities
are Market Analysis, Initiating New Product Developments, and Business development. He is an expert for syringe pro-
cessing. He is member of the “PDA Interest Group Pre-filled Syringes” and works as an expert in the DIN/ISO group for pri-
mary packaging. He is a popular speaker at conferences covering trends and solutions for fill/finish equipment especially
for pre-filled syringes and single-use-filling-systems.

Bernd Zeiss, Head of Global Technical Support Gx® Solutions & Syringe Systems, Gerresheimer
Bernd Zeiss is biologist by education and graduated from the University of Göttingen, Germany. After several years work-
ing as a biostatistician, in lab automation and in pharma sales, he today is a member of the Gerresheimer business devel-
opment team since 2011. Currently he works in the Gerresheimer Centre of Excellence for pre-fillable syringes as Head
of Technical Support Medical Systems. His main areas of work are technical customer support with regard to syringe
systems as well as investigating possible interactions between syringe components and drug substance.

26 pda.org/EU/TC_PFS19
 TRAINING COURSE AGENDA

9 Okt. 2019

Thursday, 24 October 2019 9:00 – 17:30 Friday, 25 October 2019 9:00 – 15:45

9:00 Welcome 9:00 Recap Day 1

9:15 Overview and Introduction into Pre-filled 9:30 The Syringe (Body) - Example Specification
Syringe Market • Materials (glass, polymer)
• Overview & Trends • Shape
• Stakeholders • Cone
• User’s perspective • Diameter
• Mechanical properties
10:15 Technical Aspects • Chemical Properties
• Syringe • Siliconization
• Stopper • Impact of different drug properties
• Plunger • Dual-chamber syringe
• Needle • Needle shield, tip cap
• Needle shield • Nest, tub
• Autoinjector • Integrated needles, luer lock adapter, cone
• Regulatory guidelines and technical types
standards: EU / US / ISO / … • Back stops, rods
• Regulatory guidelines and technical
11:15 Coffee Break standards: EU / US / ISO / …

11:45 Overview and Introduction into Drug-syringe 10:15 Coffee Break

Interactions
• Aggregation 10:45 Plunger Stopper, Needle Shields, Tip Caps
• Degeneration • Materials
• Oxidation • Physical properties
• Viscosity • Chemical properties
• Bubbles • Washing
• Siliconization
12:15 Lunch Break • Impact of different drug properties
• Syringe system functionality
13:15 Overview and Introduction to Manufacturing • Regulatory guidelines and technical
Process of Pre-filled Syringes standards: EU / US / ISO / …
• Barrel forming
• Washing 11:45 Manufacturing Aspects Regarding Filling,
• Siliconization Finishing and Assembly
• Sterilization • Bulk versus nested
• Regulatory guidelines and technical • Nest sizes
standards: EU / US / ISO / … • Standard processing for Rod Insertion and
Labelling
14:00 Fill and Finish • Handling of syringes considering glass to
• Filling glass vs. no glass to glass contact
• Stoppering
• Assembly 12:30 Lunch Break
• Technical Standards: ISO
13:30 Assembly of Syringes and Administration
14:45 Hands-on Session 1 Devices
• Pen Injectors
15:45 Coffee Break • Safety Systems
• Autoinjectors
• Manual versus automated
16:15 Hands-on Session 1 (cont.)
Design Independent Assembly
17:15 Q&A
14:30 Hands-on Session 2
17:30 End of Day 1
15:30 Q&A

15:45 End of Course

pda.org/EU/TC_PFS19 27
 pda.org/EU/ParPack2020

2020 PDA EUROPE

Parenteral Packaging

25-26 FEBRUARY 2020

BASEL, SWITZERLAND

SAVE THE DATE

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Getinge is Gold sponsor for

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SECURE PLUNGER
Plunger cannot detach
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when removing the RNS.
Syringe barrel is unobscured, COST EFFECTIVE
allowing the user to check the Designed to work with
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confirm the full dose has which means no change to
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and minimises training costs. Prevention of accidental
activation e.g. in transit.

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 TWO-DAY TRAINING COURSE

Container Closure Integrity Testing

Overview
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic
approach to apply these testing methods for CCI verification throughout drug product lifecycle. The course will enable the partic-
ipants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory
and compendia requirements. In this course, participants gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory
experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies

Who Should Attend

• Parenteral drug packaging engineers and formulation scientists Presentation of Technology, Instruments Demo
• Laboratory scientific staff and managers and Hands-on Training kindly supported by
• Parenteral manufacturing staff Leak Detection Associates (LDA), Lenox Laser,
• Sterility Quality Assurance Lighthouse, Pfeiffer Vacuum, pti Inspection
• Regulatory affair scientists Systems, Sartorius Stedim, Wilco
• Pharmaceutical packaging component manufacturing staff

Learning Objectives
This course utilizes lectures, case studies, and interactive
hands-on training on testing instruments to provide insight
into the latest developments of Container Closure Integrity
(CCI) Testing, with focus on achieving the following key
objectives:
• Selecting and applying appropriate testing methods for
both laboratory and in-process testing to formulate com-
prehensive package integrity verification profiles.
• Defining CCI testing method development and validation
approach and best practices.

• Understanding up-to-date regulatory and pharmacopeia • Avoiding common issues and pitfalls in CCI testing
requirements on CCI. applications.

• Defining CCI requirements for various container and drug

product types using a risk-based approach.
• Explaining working principles of various CCI testing tech-
niques and their practical applications, with focus
on deterministic methods such as tracer gas
detection (e.g. helium leak detection), electrical conductivity
and capacitance (HVLD), vacuum decay leak detection,
laser-based gas headspace analysis, mass extraction leak
test.

Lei Li, PhD, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly
Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of
experience in pharmaceutical and medical device industry, with focus on developing API and drug product pack-
aging in support of clinical development and product commercialization, and establishing cold-chain distribution
for biologic products. His current responsibilities include developing package integrity verification profiles for Lil-
ly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting commercial control
strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at
PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his
Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as
an analytical and material scientist.

32 pda.org/EU/CCIT2019-fall-edition
 TRAINING COURSE AGENDA

9 Okt. 2019

Thursday, 24 October 2019 9:00 – 17:30 Friday, 25 October 2019 8:30 – 16:30
9:00 Welcome and Introduction 8:30 Application Case Studies – Part 2
• Vacuum and pressure decay
9:15 Regulatory Requirements: • Mass extraction
CCI introduction, regulatory requirements, and
industry trends 9:10 Hands-on Training

10:00 Introduction 10:10 Coffee Break

• CCI assurance throughout product lifecycle
• Testing requirement definition – risk based 10:40 Application Case Studies – Part 3
approach • Headspace analysis
• CCI profile & testing strategy development • HVLD

10:30 Coffee Break 11:20 Hands-on Training

11:00 CCI Test Methods: Fundamentals 12:00 Lunch Break

• CCI defects and commonly used positive con-
trols 13:00 Development and Validation of
• Evolution of CCI testing technology: liquid flow, Integrity Test Methods
gas flow, electron flow (electric current) • Method development best practices
• Method validation strategy
11:40 Methodologies for Sizing CCI Defects Using Gas • Pitfalls and solutions
Flow Dynamics • A Case study

12:00 Lunch Break 14:10 Approaches to CCI Testing Method Selection

13:00 CCI Test Methods: Overview Introduce group exercise:

• Deterministic vs probabilistic definitions • Product life cycle testing and method selection
• Physicochemical methods vs microbiological
methods: differences and correlations 14:30 Coffee Break
• Microbial and dye ingress testing basics
15:00 Group Exercise - Breakout
14:00 CCI Testing Technologies
• Vacuum and pressure decay 16:00 Group Exercise - Presentations & Discussion
• Mass Extraction
• Headspace analysis 16:30 End of Course
• HVLD
• Tracer gas (helium leak detection)
• Seal quality testing (residual seal force)

15:00 Coffee Break

15:30 Current Topics: Industry Best-Practices and

Novel Technologies
• AMI optical emission spectroscopy for
CCI testing & demo

16:00 Application Case Studies – Part 1

• Tracer gas (helium leak detection)
• API container testing using helium leak
detection & video

17:30 End of Day 1

Allison L. Dill, PhD, Senior Research Scientist, Eli Lilly and Company
Allison Dill, is a Senior Research Scientist in Delivery and Device Connected Solutions at Eli Lilly and Company,
Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University, and worked for 4 years as an
analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D.
in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characteri-
zation. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral
dosage forms and has contributed to several regulatory submissions. Her recent contributions have focused on
enabling the delivery of the early phase portfolio within a complex global network with responsibility for the analyti-
cal control strategy of both the active pharmaceutical ingredient and the drug product. She is now focusing on the
CCI strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection.

pda.org/EU/CCIT2019-fall-edition 33
 TWO-DAY TRAINING COURSE

Test-Methods for
Pre-filled Syringe Systems
Overview
The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will
benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a
PFS from the idea to finished marketed product.

Who Should Attend

• The course is designed specifically for those who are • Engineers and Managers in Device Development and all
involved or interested in the development, manufacturing other technical functions surrounding syringe systems
and QC-testing of a Pre-filled Syringe System • Quality Personal / Regulatory Personal
• Clinical and commercial Drug Product Manufacturing

Learning Objectives
• Materials used for PFS Systems
• Luer Cone and Luer Lock Compliance Testing
• Requirements for the empty sterile sub-assembled syringe ready for filling
• Test Methods for Drug Product Filled Syringes
• PFS used in Delivery Systems

Horst Koller, CEO, HK Packaging Consulting

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging
with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regu-
latory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an
active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international
conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mann-
heim / Germany.

Roman Mathaes, PhD, Senior Group Leader, LONZA Drug Product Services
Roman is leading the LONZA particle lab and the container closure integrity testing. In this role, he is responsi-
ble for container closure integrity testing of vials and Pre-filled syringes and process development of capping /
crimping. Prior to this assignment, Roman was working within Roche / Genentech network supporting process
development of the commercial manufacturing vial capping process. Roman is a pharmacist by training and
conducted his studies at the University of Marburg and King’s College London. He holds a PhD in Pharmaceutical
Technology from the University of Munich for work on subvisible particle characterization.

34 pda.org/EU/TMPFS2019-fall-edition
 TRAINING COURSE AGENDA

9 Okt. 2019

Thursday, 24 October 2019 9:00 – 17:45 Friday, 25 October 2019 9:00 – 15:30

9:00 Welcome 9:00 Regulatory Requirements of

Finished Pre-filled Syringes – Part 1
• System Characterization / Physical
9:15 Introduction of Pre-filled Syringes and Characterization
Materials Used to Manufacture Syringes

10:15 Coffee Break

10:30 Coffee Break

10:45 Regulatory Requirements of

11:00 Luer cone and Luer lock Compliance Testing Finished Pre-filled Syringes – Part 2
for Glass and Polymer Syringes • Pharmaceutical Characterization

Requirements for the Empty Sterile Sub-

assembled Syringes Ready for Filling- Part 1) 11:45 Challenges of Syringe Systems and
• Cone Breakage / Flange Breakage Components
• Parenterals and Ophthalmics

12:30 Lunch Break

12:30 Lunch Break

13:30 Requirements for the Empty Sterile Sub-

assembled Syringes Ready for Filling- Part 1 13:30 Challenges of Syringe Systems and
(cont.) Components (cont.)
• Closure Testing • Parenterals and Ophthalmics

15:30 Coffee Break 14:15 Additional Testing for Use in Delivery Devices

16:00 Requirements for the Empty Sterile Sub- 15:15 Wrap-up of Day 2
assembled Syringes Ready for Filling- Part 2
• Break Loose and Gliding Force / Needle
Testing / Particulate Matter 15:30 End of Course

17:30 Wrap-up of Day 1

Hands-on
17:45 End of Day 1
Training
kindly supported by
ZwickRoell

pda.org/EU/TMPFS2019-fall-edition 35
 TWO-DAY TRAINING COURSE

Extractables & Leachables

Including: Important Regulatory Updates –
Case Study Section: Selection of the most interesting Case Studies,
presented over the last 10 years!

Overview
When making Parenteral Drug Products, pharmaceutical companies are faced with the need to further investigate the materials
that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or
during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of
investigations, recently, also quality issues – i.e. for biopharmaceuticals – have become an additional concern.

This workshop will look at “Extractables & Leachables” from many different angles: Definitions, Regulatory, Material & Polymer
Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral primary packaging systems,
as well as for injection devices.

Who Should Attend Learning Objectives

• Pharmaceutical Packaging and Device Engineers
• Production Engineers, using SU systems
• Regulatory Affairs Officers
• Pharmaceutical R & D Managers
• Analytical Chemists, working on E/L
• Quality Assurance Officers
Upon completion of this workshop, you will be able to:
• Explain in detail the current regulatory requirements for
container/closure qualification from an E/L perspective.
• Explain the upcoming changes in regulations, standards and
recommendations from PQRI, USP and BPOG and how these
changes could impact a future evaluation of a pharmaceutical
C/C-system.
• Understand the materials of construction – and their
composition – of container closure systems, and how they could
impact the safety and quality of a parenteral drug product.
• Put together an evaluation program (review of provided docu-
mentation, analytical testing) of different types of parenteral drug
product container/closure systems.
• Perform a safety/risk assessment of analytical results,
obtained after completion of an E/L study.

Dennis Jenke, PhD, Chief Executive Scientist, Triad Scientific Solutions

Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions
to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery
devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter
Healthcare Corporation where for more than three decades he lead a team whose primary responsibility includes
the assessment of material/product compatibility, specifically with respect to establishing the suitability for use
of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for ex-
ample, extractables/leachables and product ingredient binding). He has published extensively in the areas of ana-
lytical chemistry, environmental science and material/solution compatibility and serves as an expert reviewer for
numerous pharmaceutical and analytical journals. He is the author of the book Compatibility of Pharmaceutical
Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables and a con-
tributing author to the Leachables and Extractables Handbook. Dennis Jenke is a member of numerous industry
groups whose charter is to establish best demonstrated practices in the area of material/solution compatibility.

36 pda.org/EU/E-and-L2019-fall-edition
 TRAINING COURSE AGENDA

9 Okt. 2019

Thursday, 24 October 2019 9:00 – 18:00

Introduction on Extractables & Leachables (E/L)

▶▶ What is the importance of a good E/L-qualification
▶▶ Historical cases of leachables, impacting the quality or the safety of a drug product
▶▶ Regulatory requirements (FDA, EMA…) for primary packaging
Understanding the Materials, Used in the Manufacture of Pharmaceutical Containers & Closures
▶▶ Types of polymers – examples in medical/pharmaceutical use
▶▶ Understanding the composition of polymers
▶▶ The issues with glass in parenteral applications
FULL Session on Updates of E/L- Regulations, Standards and Recommendations
▶▶ Pharma Packaging:
▶▶ Preview of the final PQRI Parenteral Drug Product (DPD) & ODP Chemistry group
▶▶ Update on the most recent developments on the USP <661> chapters
▶▶ Devices
▶▶ Chemical characterization of devices according to ISO 10993-18: What changes are coming up?
▶▶ Upcoming Revisions of the USP <87> and USP <88>: Where could it go to?
▶▶ (Bio)Pharmaceutical Manufacturing
▶▶ Where is USP with the update on the USP <661.3> Plastic Manufacturing Components standard
How to Perform a Safety Evaluation – Risk Assessment on Extractables & Leachables
▶▶ Toxicology 101
▶▶ EMA Guideline on Genotoxic Impurities
▶▶ ICH M7 (DNA reactive Impurities) and its suggested staged approach
▶▶ The Threshold Concept of PQRI (OINDP and PDP/ODP)
▶▶ Examples
How to Look at Injection Devices from an E/L Perspective
▶▶ Medical device regulations versus pharma packaging
▶▶ Test selection process for devices: What to do?
▶▶ USP and ISO 10993 series for biocompatibility testing
▶▶ Case: Injection device

Piet Christiaens, PhD, Scientific Director, Nelson Labs

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Bel-
gium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997
to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas where he
conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-Polymers (Kraton
Polymers). Since 2001, Piet Christiaens has been Scientific Director at Nelson Labs Europe where he develops
analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceuti-
cal Industries. He oversees all laboratory operations at Nelson Labs Europe and supports the European business
development team.

pda.org/EU/E-and-L2019-fall-edition 37
 TRAINING COURSE AGENDA

Friday, 25 October 2019  9:00 – 16:30

E/L Testing for Small Volume Parenteral Applications

▶▶ Glass Syringes: the issues with tungsten, glue residues and silicone oil and glass metals leaching
▶▶ The Issue with rubbers: the plunger, the needle shield or the tip cap: different approaches needed?
▶▶ The impact of secondary packaging – option or necessity?
▶▶ Setting up extractable & leachable studies for a pre-filled Syringe or a vial system
E/L Testing for Lyophilized Drug Products
▶▶ Primary packaging for the lyophilized drug product – modus of interaction with the DP
▶▶ Impact of the “21CFR Part 4” on combination products, used in the administration of a lyo DP
▶▶ Critical aspects when designing leachable studies for lyophilized DP
▶▶ Integration of the administration procedure (e.g. IV-set, pump system) in leachables evaluation
Large Volume Parenterals
▶▶ The challenge in E/L testing for LVP’s
▶▶ Primary packaging for LVP’s – critical materials and components
▶▶ Secondary packaging for LVP: critical points to consider
E/L Testing for Disposable and Single-Use Systems in Bioproduction
▶▶ How to classify the risk of different single-use systems in the bioproduction process
▶▶ Understanding BPSA & BPOG recommendations, and how they can be implemented in the study design
▶▶ Performing E/L studies on filters: potential approaches
Analytical Techniques and Methodologies in E/L Research
▶▶ Discussion of the Analytical Instrumentation used
▶▶ The Analytical Chromatographic Screening Process to Discover, Identify and Quantify Organic Extractables
▶▶ The Risk of Omissions with the Screening Process
▶▶ The Risk of Inexact Identifications in the Screening Process
▶▶ The Risk of Inaccurate Quantification when Sscreening
▶▶ A Risk Mitigation Strategy when Implementing a Screening Methodology
How to Set-up Extractables & Leachables Studies
▶▶ Selecting the right conditions for extraction
▶▶ How to select the right compounds to monitor in a leachable study
▶▶ Designing a leachable study

John Iannone, Principal Consultant, iCG Solutions

John Iannone has a background in Biomedical Engineering from Boston University. Since joining the Biotech/
Medtech Industry 15 years ago, John has assisted multiple pharmaceutical & medical device companies with the
development of their product safety evaluation strategies. Currently he is a Principal Consultant for iCG, LLC. His
areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Char-
acterization, and attainment of Biological or Toxicological risk assessments for medical devices, pharmaceutical
container systems, bioprocessing systems, and combination products. John has given numerous technical pre-
sentations and has led many workshops on Extractable & Leachable Considerations, Biocompatibility, Microbi-
ology, and Regulatory Testing Requirements. He also participates in the development of both industry groups’
recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees,
and industry collaborations.

38 pda.org/EU/E-and-L2019-fall-edition
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 pda.org/calendar

2020 PDA EUROPE

Visual Inspection
Forum

21-22 APRIL 2020

BERLIN, GERMANY

SAVE THE DATE

 INFORMATION

VENUE
The Swedish Exhibition & Congress Centre
Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden
Tel: +31 750 88 00
https://en.gothiatowers.com/
Hotel Accommodation
optiMICE is the official housing provider for The Universe
of Pre-filled Syringes and Injection Devices 2019.
We recognize that attendees have many options with area
hotels, and that you may be looking only at the per night
cost in making your decision. However, we encourage you
to understand the importance and recognize the benefits
of selecting the conference hotel.
G E N E R A L A DDRESS
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: + 49 30 436 55 08-0
Fax: + 49 30 436 55 08-66
CO N FE RE N C E REG ISTR ATIO N H OU RS
Monday, 21 October: 9:00 – 17:00
Tuesday, 22 October: 8:00 – 17:30
Wednesday, 23 October: 8:00 – 12:00
COU RS E REG ISTR ATIO N H OU RS
Thursday, 24 October: 8:00 – 16:30
Friday, 25 October: 9:00 – 12:00

BOOK YOUR TO E X HI BIT:

ROOM HERE Exhibition and Sponsorship Opportunities are available.
t1p.de/ups-travel PDA meetings and conferences are a great opportunity for
your company to gain on-site exposure in front of highly-
qualified, upper-level professionals in the pharmaceutical
DI RECTIO NS and biopharmaceutical industry. Exhibit at PDA events
and let your company’s products or services become a
valuable tool or resource for our attendees.

S PECIA L REQ UI RE M E NTS

If you require special accommodations to fully
GOTHIA TOWERS HOTEL participate, please attach a written description of
GOTHENBURG your needs with your registration form. Specific
questions can be directed to registration-europe@pda.org.

© Google For directions click on the picture, scan the

QR-code or go to https://goo.gl/maps/Uxz5UEbZxp32

CO NTACT I N FO RM ATIO N
Conference Inquiries
Melanie Decker
Director Events & Exhibitions
decker@pda.org Special offer: Discounted travel with Lufthansa Group Airlines
Conference Program Inquiries Lufthansa Group Partner Airlines offer a comprehensive global
Sylvia Becker route network linking major cities around the world. We offer spe-
programs-europe@pda.org cial prices and conditions to participants, visitors, exhibitors, in-
vited guests as well as employees of the Contracting partner and
Registration Customer Care their travel companions. To make a reservation, please click on
Tel: + 49 30 436 55 08-10 www.lh.com/event-flight-booking and enter the access code
registration-europe@pda.org DEZQWBE in the "Access to Your Special Lufthansa Offer" area. This
Training Program Inquiries will open an online booking platform that will automatically calcu-
Elke von Laufenberg late the discount offered or provide you with an even better offer if
training-europe@pda.org another promotional fare is available.
Exhibition/Sponsorship Inquiries NOTE: Pop-ups must be enabled otherwise the booking platform
Christopher Haertig window will not open.
expo-europe@pda.org These promotional fares are also available through your IATA /
Marketing Inquiries ARC travel agent. Travel agents can obtain ticketing instructions by
Mark Roediger sending an email to lufthansa.mobility@dlh.de and providing the
roediger@pda.org access code as a reference.

pda.org/EU/UPS2019 43
 The Universe of Pre-filled Syringes and Injection Devices Reg Form Page 1

21-25 October | Gothenburg | Sweden This PDF-file provides an automatic

fill-in function. Your signature,
however, is needed in writing.

Your registration is only complete upon filling in and submitting both pages of this form.

1 Registration EARLY BIRD DISCOUNT Book by 25 Aug 2019 to receive € 200 off the conference fee only

All fees given in Euro, excluding VAT (25 %)

22-23 October Conference only Conference Fee

The Universe of Pre-filled Syringes and Injection Devices PDA Member 1995

¹Nonmember 2295

²Young Professionals 1000

¹Regulatory/Academic 1000
Poster Presenter please mark here (written approval required, conference fee applies)

21 October One-Day Workshop Workshop Fee

Innovating the Journey from Manufacturing to the Patient All Participants  795

21 October One-Day Workshop Workshop Fee

Innovative Drug Delivery Sytems / Combination Products All Participants  795

21 October One-Day Workshop Workshop Fee

Impact of Pre-Filled Syringe Components on Biopharmaceuticals All Participants  795

24-25 October Two-Day Training Course Training Course Fee

Container Closure Integrity Testing All Participants  1595

24-25 October Two-Day Training Course Training Course Fee

Extractables and Leachables All Participants  1595

24-25 October Two-Day Training Course Training Course Fee

Test Methods for Pre-Filled Syringe Systems All Participants  1595

24-25 October Two-Day Training Course Training Course Fee

All About Pre-filled Syringe Systems - From Initial Development to Final Fill Finish All Participants  1595

The fee includes event documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks
and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a
special group rate.
¹Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and
receive the benefits of membership, please check here (same rate applies).
² Rate applicable to all professionals 30 years of age or younger. A proof via ID or Passport copy is required, please submit this via fax or e-mail.
Rate does not include membership. Group Discount is not applicable to this rate.
Group Registration Discount Register 3 colleagues for the conference at the same time and receive the
Join PDA and receive the
4th registration free. Other discounts cannot be applied. For more information on group discounts please contact Membership Rate Today!
at registration-europe@pda.org. Please got to:
pda.org/membership
Discount for Exhibiting Companies
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1545 € per ticket.
No further discounts are applicable with this option (as PDA Membership Discount or Group Discount).

44 pda.org/EU/UPS2019
 Reg Form Page 2 The Universe of Pre-filled Syringes and Injection Devices

This PDF-file provides an automatic

fill-in function. Your signature,
21-25 October | Gothenburg | Sweden
however, is needed in writing.

3 WAYS A
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online: pda.org/EU/UPS2019

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FAX: + 49 30 436 55 08-66
Email: registration-europe@pda.org

2 Your Contact Information If this form is an update to a previously submitted form, please check here.

Mr. Ms. Dr. Nonmember I want to become a PDA Member.

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Substituting for
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3
•• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event
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submitting documents by courier.)
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M PDA sending me promotional information via email.
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P PDA sending me promotional information via post
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Your registration is only complete upon filling in and

submitting both pages of this form.

Date Mandatory Signature

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally
binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must
have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully
settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee,
please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of up to € 100 excl. VAT per name
change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 22 September 2019 you will receive a full refund minus a 150 € excl. VAT handling fee.
After that time, no refund or credit requests will be approved. No-shows are responsible for paying the full registration fee. Late and on-site registration does not guarantee access to complete event
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pda.org/EU/UPS2019 45
 europe.pda.org

PDA EU ROPE E V ENTS

2 019
Workshops:
21 October Innovating the Journey from Manufacturing to the Patient
21 October Innovative Drug Delivery Systems/Combination Products Gothenburg, Sweden
21 October Impact of Pre-filled Syringe Components on Biopharmaceuticals
22-23 October The Universe of Pre-filled Syringes and Injection Devices

12-13 November Pharma Logistics & Outsourced Operations

Lisbon, Portugal
14 November Interest Group Meeting Supply Chain Management

2020
25-26 February Parenteral Packaging Basel, Switzerland

21-22 April Visual Inspection Forum Berlin, Germany

9-10 June Quality and Regulations Conference Dublin, Ireland

22-23 June Virus Forum Brussels, Belgium

24-25 June Advanced Therapy Medicinal Products Brussels, Belgium

8-9 September Medical Devices and Connected Health TBC, Europe

22-23 September BioManufacturing TBC, Europe

24 September Pharmaceutical Freeze Drying Technology TBC, Europe

20-21 October Aseptic Animal Health TBC, Europe

Subject to change For latest info: europe.pda.org Shortlist 9 Oct 2019

GENERAL INFORMATION
PDA EUROPE GGMBH
AM BORSIGTURM 60
13507 BERLIN, GERMANY
TEL: +49 30 4365508-0
FAX: +49 30 4365508-66
INFO-EUROPE@PDA.ORG