Joint TOPRA-EMA meeting - New European Variations Legislation and Guidelines

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Price: £50.00

This session will explain each key provision in more detail, in particular its practical implementation (submission, review procedure, assessment outcome, implementation), by means of a joint presentation by representatives from CMD, EMA and industry. The speakers will present their views on each of the topics, such as Type IA grouping, Type IB default, grouping & work sharing, in a complimentary form, before inviting comments from the audience.

Introduction: Background and future work sharind - Peter Bachmann and Hilde Boone
Industry viewpoint on work sharing - Fiona Reekie - Director, Global Regulatory Affairs Strategic Policy & Support Policy & Intelligence EMEA Johnson & Johnson Pharmaceuticals, UK
Panel Session - The speakers take questions from the floor