CRED Variations 2017
7 June 2017
DoubleTree by Hilton Victoria, London, UK
Workshop Chair : Shilpa Jain, Senior Regulatory Affairs Consultant, TRAC Services Ltd.
08.45 Registration Opens/Coffee
Senior Regulatory Affairs Consultant,
Welcome from TOPRA Overview of the day
TRAC Services Ltd.
09.10 Principles of Variations Regulations and Guidelines
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)
Head of Service, Procedure Management Department, EMA
11.15 Procedures & their impact on regulatory strategy and implementation
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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