CRED Managing Variations Effectively

CRED Managing variations effectively 7 June 2018, TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE Chair: Shilpa Jain, TEVA Time Activity Speaker 09.00 Registration

Welcome from TOPRA

Samantha Alsbury Head of Professional Development TOPRA

09.30

Chairperson’s Introduction

Shilpa Jain Specialty European Regulatory Affairs Manager - Respiratory TEVA Richard Keane Associate Director, Global Regulatory CMC Biogen Idec

09.35

Principles of Variations Regulations and Guidelines • Introduction to Variations • Legal Basis of Variations • Introduction to Classification of Variations • Unforeseen variations • Introduction to Grouping and Work-sharing, • Practical issues for submissions Introduction to Classification – CMC/ Clinical/ PhV Variations • Overview of the categorisation annex of the variation guideline • Type IA/IAIN, Type IB and Type II variations • Variations relating to the quality dossier • Variations relating to safety/efficacy/PV • Handling of variations by EMA • Feedback from usage of the system from a Regulatory Authority perspective (for centralised submissions) Procedures & their impact on regulatory strategy and implementation • Grouping, Work-sharing • Submission strategy • Feedback from usage of the system from a Regulatory Authority perspective. • MRP/DCP considerations Tea/ coffee break Panel session Lunch

09.40

10.15

Alberto Ganan Jimenez Head of Procedure Management Service D in the Medicines Evaluation Division, and Jaime Oliva Procedure Manager EMA

10.30

11.45 12.05

All

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

12.50

14.05

Introduction to Case Study