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Variations

7 June 2017

DoubleTree by Hilton Victoria, London, UK

Workshop Programme

Workshop Chair : Shilpa Jain, Senior Regulatory Affairs Consultant, TRAC Services Ltd.

08.45 Registration Opens/Coffee

Shilpa Jain

09.00

Chairperson’s Introduction

Senior Regulatory Affairs Consultant,

Welcome from TOPRA Overview of the day

 

TRAC Services Ltd.

09.10 Principles of Variations Regulations and Guidelines

Isabel Zwart

 Overview of the key principles of Regulations 1234/2008 and 712/2012  Introduction to different Types of variations  Introduction to Grouping and Worksharing,  Unforeseen variations  Centralised, mutual recognition, national applications  Practical issues for submissions

Senior Manager, CMC Regulatory Affairs Biogen Idec

Alberto Ganan Jimenez

09.45 Introduction to Classification – CMC/Clinical/PhV Variations

Head of Service ‘Evaluation Procedures D’, Procedure Management and Business Support Department, EMA

 Overview of the categorisation annex of the guideline  Type IA/IA IN , Type IB and Type II variations  Variations relating to the quality dossier  Variations relating to safety/efficacy  Variations to the pharmacovigilance system  Feedback from usage of the system from a Regulatory Authority perspective (for centralised submissions)

Iordanis Gravanis

Head of Service, Procedure Management Department, EMA

11.00 Coffee

11.15 Procedures & their impact on regulatory strategy and implementation

Krystyna Fielden

Manager, Product Lifecycle Assessment Team 2 (Dermatology, Respiratory, Sensory & Endocrine Medicines) MHRA

 Grouping, Worksharing, Annual Reports  Worksharing procedures  Grouping  Type IA Annual Reports  Feedback from usage of the system from a Regulatory Authority perspective.

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