SPEAKERS:

Fiona McLeod
European Directorate for the Quality
of Medicines (EDQM & Health Care),
France
Boris Pimentel
Pi-Consulting, Switzerland
Wilhelm Schlumbohm
Berlin, Germany
Jan Smeets
DSM Sinochem Pharmaceuticals,
The Netherlands

PROGRAMME:
Dossier Requirements for the Drug
Substance An Introduction
How to Compile an ASMF
Requirements for the Certicate of
Suitability
Drug Substance - Setting Specica-
tions
Stability Data
Description of the Manufacturing
Process and Process Controls
Impurities and Residual Solvents
Handling of Variations/Changes in
Europe and the US
Comparison of CEP and ASMF
Procedure
CTD, CEP and Active
Substance Master File

Quality of Drug Substance
24-25 March 2015, Heidelberg, Germany
wa/vers1/10092014 This education course is recognised for the ECA GMP Certication Programme Certied Regulatory Affairs Manager. Please nd details at www.gmp-certication.eu
Choose 2 out of 4 Parallel Workshops
Stability Studies and Establishing the Retest Date
Description of the Manufacturing Process
How to Compile Data for Impurities and Residual
Solvents
Questions and Answers of the CEP Procedure
Objectives
This education course is intended to provide guidance
on the format, content and submission procedures for
the pharmaceutical documentation of the quality of the
drug substance for different types of dossiers, the CTD,
the CEP and the European ASMF and the US-DMF. Fur-
thermore, the impact of the variations regulations will be
discussed.
Participants will have the opportunity to choose 2 out of
4 parallel workshops:
Stability studies and establishing a retest date
Description of the manufacturing process
How to compile data for impurities and residual
solvents
Questions and answers of the CEP procedure
Background
In Europe there are several ways to document the quality
of the drug substance for the purpose of marketing au-
thorisation:
Certicate of Suitability of the pharmacopoeial
monograph (CEP)
Full details of manufacture (according to CTD Module
3 Quality of Drug Substance)
European Active Substance Master File (ASMF; former
Drug Master File, DMF)
Other evidence of suitability of the pharmacopoeial
monograph
In the US, the quality of the drug substance can be docu-
mented as part of the CMC Dossier or in a US-DMF.
Target Group
The education course is designed for all persons in-
volved in the compilation of pharmaceutical dossiers for
marketing authorisations who want to become familiar
with the different ways to document the quality of the
drug substance for the purpose of marketing authorisa-
tion in Europe. Furthermore, the course will be of interest
to personnel from Quality Units of the pharmaceutical
and the API industry.
Social Event
On 24 March, you are
cordially invited to a
social event. This is an
excellent opportunity to
share your experiences
with colleagues from oth-
er companies in a
relaxed atmosphere.
Programme
General Part
Dossier Requirements for the Drug Substance
An Introduction
Chemical pharmaceutical documentation for active
substance(s) Regulatory requirements in EU, USA
Types of active substances types of documentation
CTD Module 3, CEP and ASMF (former DMF)
CEP for a substance for TSE risk assessment
Dr Wilhelm Schlumbohm
Germany
How to Compile an ASMF Using the CTD Format
Structure of the ASMF
Compilation of an ASMF; how to start
Compilation steps and technical approaches
ASMF and eCTD
eCTD vs. NEES
DMF systems in the US, Japan and Latin America
Dr Boris Pimentel
Pi Consulting, Switzerland
Requirements for the Certicate of Suitability
Regulatory basis: Resolution AP-CSP (99)4 of the
Council of Europe
CEP Procedure
Content of the CEP dossier with practical examples
Administrative minor and major changes, 5 years
revision
Fiona McLeod
European Directorate for the Quality of Medicines (EDQM &
Health Care), France
Special Part
Drug Substance - Setting Specications
Denition of specication
ICH/CHMP guidelines
Pharmacopoeial tests and acceptance criteria
Specications in API development
Criteria for the specication of impurities
Justication of specications
Dr Wilhelm Schlumbohm
Germany
Stability Data
CPMP/ICH Guidelines
Stability Summary and Conclusions, stability
commitment
Documentation of Stability Data
Necessity for documentation of raw data?
Dr Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands
CTD, CEP and Active Substance Master File
24-25 March 2015, Heidelberg, Germany
Description of the Manufacturing Process and Process
Controls
The regulatory framework for manufacturing APIs
Most frequent issues on manufacturing process
description
Format and content of the MP Chapter CTD-3.2.S-2
The CTD Module 3 Quality: 3.2.S.2
Critical issues in the process description
CEP specic requirements
Dr Boris Pimentel
Switzerland
Impurities and Residual Solvents
CPMP/ICH Guidelines Impurities and Residual
Solvents
Specifying Impurities
Classifying solvents, setting and proving limits
Justication of Specication
Dr Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands
Regulatory Compliance
Handling of Variations/Changes in Europe and the US
The EU Variations Regulation and detailed
Guidelines
Types of Changes
Remaining problems of changes for the API Industry
Change system for APIs in EU
Change System for APIs in USA
New FDA initiatives to facilitate changes
Preferred options for Bulk Pharmaceutical Industry to
solve post-approval change problems
How to handle variations in the ASMF and the CEP
procedure
Dr Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands
Comparison of CEP and ASMF Procedure
Advantages of the CEP procedure
Handling Changes
In which countries is the CEP being accepted?
Cost Considerations
Practical examples
Dr Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands
Parallel Workshops
Please choose two out of four parallel workshops
Stability Studies and Establishing the Retest Date
Dr Jan Smeets
Description of the Manufacturing Process
Dr Wilhelm Schlumbohm
How to Compile Data for Impurities and
Residual Solvents
Dr Boris Pimentel
Questions and Answers of the CEP Procedure
Fiona McLeod
Important: In order to prepare the lectures and the
workshops in an optimal way, please send your ques-
tions to special topics to Dr Gerhard Becker, email:
becker@concept-heidelberg.de. He will forward your
questions to the responsible speaker. Thank you in ad-
vance for your cooperation.
Fiona McLeod
Certication Division, European Directorate for the Quality of
Medicines (EDQM & Health Care), France
Graduated in Pure Chemistry. She worked for 18 years for major
pharmaceutical company in various analytical chemistry roles
in both QA and development activities then in regulatory
affairs. She then joined the European Directorate for the Quality
of Medicines & HealthCare in 2004, where she is a scientic
ofcer with the Certication Division. She is a member of the
team dealing with new dossiers and also has responsibilities for
e-submissions and IT solutions for the division.
Dr Boris Pimentel
Pi-Consulting, Switzerland
Dr Pimentel is manager of the consulting company
for global regulatory services Pi-Consulting in
Switzerland. Until June 2014 he worked on the
Dutch company DSM Nutritional Products in
Switzerland, focusing in Pharma and Food regulations. Since
2010 as a member of the APIC board he was involved in several
task forces like ASMFs, Variations and Changes, and participat-
ed in the discussions with EMA, WHO and EDQM. He also
chaired the task force for Japan regulations, and Emerging
Market Regulations.
Dr Wilhelm Schlumbohm
Berlin, Germany
More than 20 years with German drug licensing au-
thorities, assessment of the CMC parts of new drug
applications, regulatory affairs, inspections in con-
nection with licensing applications of medicinal
products (pre-approval inspections). Rapporteur and member of
the Technical Advisory Board for the Certication Procedure.
Dr Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands
10 years with Gist-brocades, 12 years with DSM and
now with DSM Sinochem Pharmaceuticals with
different positions in Research & Development,
Regulatory Affairs and Technical Sales Services for
APIs and intermediates. Currently Director Regulatory Affairs &
Technical Sales Services. Responsible for worldwide submissions
and regulatory approvals. Dutch representative in group 7
(antibiotics) of the European Pharmacopoeia.
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Date
Tuesday, 24 March 2015, 9.00 h 18.00 h
(Registration and coffee 8.30 h 9.00)
Wednesday, 25 March 2015, 8.30 h 16.00 h
Venue
Crowne Plaza Heidelberg
Kurfrstenanlage 1
69115 Heidelberg, Germany
Phone +49 (0) 6221 917 0
Fax +49 (0) 6221 21007
Heidelberg Optimal Accessibility via Frankfurt:
Lufthansa Shuttle Bus:
It leaves Frankfurt Airport approximately every 60 minutes
to the Heidelberg Crowne Plaza Hotel.
Info: www.lufthansa.com/de/en/Lufthansa-Airport-Bus
Airport Shuttle Service: Airport shuttle services bring you
promptly and reliably from the airport to your hotel.
Info: https://www.tls-heidelberg.de/en/home/
Train: You can get on the train at the Airport Station.
A train leaves up to three times per hour and it usually
takes less than one hour to get to Heidelberg.
Fees (per delegate plus VAT)
ECA Members 1,590
APIC Members 1,690
Non-ECA Members 1,790
EU GMP Inspectorates 895
The fee is payable in advance after receipt of invoice and
includes conference documentation, social event and
dinner on the rst day, lunch on both days and all refresh-
ments. VAT is reclaimable.
Accommodation
CONCEPT has reserved a limited number of rooms in the
conference hotel. You will receive a room reservation
form when you have registered for the course. Reserva-
tion should be made directly with the hotel. Early reserva-
tion is recommended.
Conference language
The ofcial conference language will be English.
Organisation and Contact
ECA has entrusted Concept Heidelberg with the
organisation of this event.
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34
info@concept-heidelberg.de
www.concept-heidelberg.de
For questions regarding content:
Dr Gerhard Becker (Operations Director) at
+49 (0) 62 21 / 84 44 65, or per e-mail at
becker@concept-heidelberg.de.
For questions regarding reservation, hotel,
organisation etc.:
Ms Susanne Ludwig (Organisation Manager) at
+49 (0) 62 21 / 84 44 44, or per e-mail at
ludwig@concept-heidelberg.de.

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Reservation Form:
CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg
Germany

Reservation Form:
+ 49 6221 84 44 34
@
e-mail:
info@concept-heidelberg.de

Internet:
www.gmp-compliance.org
wa/vers1/10092014
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