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