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EMA/IFAH-Europe Info Day 2014

London, 13 March 2023

 

 

The EMA/IFAH-Europe Info Day took place on 13-14 March at the EMA offices in London with a record attendance of over 160 delegates. 

 

 

 

Presentations

Session I
Anja Holm - CVMP Work Plan for 2014 
Karen Quine - Pharmacovigilance: the industry perspective 
Jos Olaerts - Pharmacovigilance: the EMA's view

Session II
Mario Magtzaam - Upcoming actions for implementing MRL regulation 
Bruno Urbain - Approach for injection site residues 
Gesine Hahn - Demonstration of efficacy for veterinary medicines containing antimicrobials 
Nicolas Jarrett - Update on guidance on user safety 

Session III
David Murphy - Clarification of MUMS policy 
Alexander Böttner - Industry feedback on MUMS policy
Jóhann M. Lenharðsson - Packaging and labelling 
Fia Westerholm, Nikolaus Križ - Pre-submission phase and guidance for novel products 
David Mackay - Trends in Veterinary Medicines 

Session IV
Melanie Leivers - Variations and progress on worksharing & CMDv Comments 
Rose-Marie Molina - Variation guidelines: impact on admin burden and fees 
David Mackay - EMA IT strategy 
Agneta Brandt - Update on Agency move 

 

 

 

 

Programme:
This annual event serves as an opportunity for professionals to get first-hand information on current developments in the regulatory scene with good networking opportunities.

Download full programme of the event 

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