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Best Industrial Training Program in Regulatory Affairs by GIRA in Pune
Best Industrial Training Program in Regulatory Affairs by GIRA in Pune
Dear Student,
We wish to inform that Global Institute of Regulatory Affairs
(GIRA) is a Group Company of Perfect Pharmaceuticals Consult-
ants Pvt Ltd (PPCPL) reputed RA consulting firm in INDIA lo-
“GIRA is an ISO 9001:2008 cated at Pune. GIRA introduces a distance learning program in
Certified Institute”
the field of Regulatory Affairs.
#LEARNING OUTCOME:
“Accredited by
Joint Accreditation System
of Australia & New Zealand
Understand Regulatory Concepts
(JAS-ANZ)” Able to write and review Regulatory Documents
Marketing Authorization from different countries
OTHER COURSES BY GIRA:
Preparation for audits and inspections
eCTD Submission Become an RA professional
QA & QC
Pharma Validation #TOPICS COVERED:
Medical Devices
Biopharmaceuticals
Food/ Food Products Intro to RA: US FDA, UK MHRA, EDQM, EMEA
Pharmacovigilance Regulatory Bodies: DCGI, CDSCO, MHLW
GMP In Pharma Industry Regulatory Guidelines: ICH & WHO Guidelines
CTD & ACTD Submissions (API & Formulation)
US Dossier Submissions: US DMF, NDA, ANDA
EU Dossier Submissions: EU DMF, ASMF, CEP/ COS
ADDRESS:
Introduction to eCTD Submissions
Module 4 & 5: Non-Clinical and Clinical Documents
Prestige Classic Building, PSUR’s Annual Updates & Renewals
D-Wing, Office No G4 & G5,
Dawa bazaar, Behind Mayur
Trade Center, Pune- Mum FOR DETAILED INFORMATION:
Highway, Chinchwad Station,
Pune – 411019
Call us at: 9595 750 750 / 020 46704472