Regulatory Affairs

Introducing the international regulatory environment and requirements related to obtaining approval for marketing vaccines and the maintenance of these licenses.

Module's directors

Dr. Anne-Marie Georges

Independent Consultant Vaccine Development and Legal Affairs
EUvacra Cahors, France

Franco Laghi Pasini, MD,Professor

Professor of Internal medicine
Dept. Of Clinical Medicine and Immunology Sciences atUniversity of Siena, Italy

Jochen Auerbach, BVetMed, PhD

Head Regulatory Affairs
GSK Vaccines institute for Global Health, Siena, Italy

Contents

Introduction:

Drug development and life cycle from a regulatory perspective:

Regulatory systems:

Product labeling:

See the lessons' list

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Lessons' List

Role of Regulatory Affairs: where does RA fit in the organization of a Vaccine Company? Description and responsibilities
National and international bodies issuing law and guidance. The ICH initiative for harmonization of data requirements. Is the world harmonized?
History of Regulatory Affairs (USA - EU)
US regulatory system (FDA, CDC, HHS) and regulatory approval procedures
Health Authorities: where do HAs fit in the organization of a Government? Description of responsibilities
European Institutions, Regulatory System and European rules for clinical trial application
European Scientific Advice: national level, EMA level
Development in Pediatrics: Clinical/Regulatory Perspectives
Principles and functioning of CHMP and Committee interactions at EMA
Other Regulatory Systems (including clinical trials), Asia, Africa and Latin America
The cinese regulatory system
A briefing on WHO and its priorities, including WHO strategy to strengthening regulatory capacity for vaccines
WHO prequalification System
Challenges for timely registration of vaccines in user countries and new approaches to registration of vaccines
International Cooperation including PAHO, UNICEF, GAVI
International Cooperation: Regulatory Networks in the world and the Gulf Cooperation Council
Introduction: vaccines and biologics technical requirements
Overview if ICH guidance on biologicals
Product labelling and promotional compliance
Regulatory authority inspections from RA perspective
The impact of the submission strategy on development
The CTA and the IMPD structure (including Workshop)
Early clinical development phase from regulatory perspective (including workshop)
Late clinical development phase from regulatory perspective (including workshop)
The impact of the submission strategy on dossier preparation
Regulatory documentation: What constitutes a dossier?
CTD structure and electronic publishing + submission
CTD Workshop
The marketing authorization dossier: Quality sections
Post approval commitments and Life cycle Management of Vaccines
The marketing authorization dossier: vaccines clinical requirements
The marketing authorization dossier: vaccines preclinical testing (including Workshop)
Changes in an approved vaccine from regulatory perspective: impact assessment; comparability, variation preparation and submission
Vaccines Life Cycle workshop
Regulatory Planning & Tracking Tools
Regulatory requirements and systems in Pharmacovigilance and safety reporting
Vaccines regulatory specificity from manufacturing to marketing authorization and during life cycle: an overview

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