European Medicines Agency/International Federation for Animal Health Europe info day 2014

• Date:
  štvrtok, 13 marec 2014, All day
• Miesto:
  European Medicines Agency, Amsterdam, the Netherlands

The info day covers latest developments in the scientific review, legislation and marketing authorisation procedure. It is an opportunity for professionals to receive first-hand information on current developments in the regulatory scene. Registration closed.

Documents

Registration form - European Medicines Agency/International Federation for Animal Health Europe info day 2014

Agenda - European Medicines Agency/International Federation for Animal Health Europe info day 2014

European Medicines Agency/International Federation for Animal Health Europe info day 2014 announcement

Presentation - CVMP work plan 2014 (Anja Holm)

Presentation - Pharmacovigilance: Vision and needs for the future (Karen Quine)

Presentation - Pharmacovigilance – vision and needs for the future: EMA perspective (Jos Olaerts)

Presentation - Upcoming actions for the implementation of Regulation (EC) 470/2009 (MRL-Regulation) (Mario Nagtzaam)

Presentation - Consumer safety issues - Approach for injection site residues (Bruno Urbain)

Presentation - Demonstration of efficacy for veterinary medicines containing antimicrobials (Gesine Hahn)

Presentation - Guidance on user safety evaluation for pharmaceutical veterinary medicinal products – development of existing and future guidance (Nicholas Jarrett)

Presentation - Clarification of MUMS policy (David Murphy)

Presentation - Minor Use / Minor Species policy industry feedback (Alexander Bà¶ttner)

Presentation - Packaging and labelling (Johann M. Lenhardsson)

Presentation - Pre-submission phase and guidance for novel products (Fia Westerholm, Nikolaus Kriz)

Presentation - Scanning the horizon - a regulatory perspective (David Mackay)

Presentation - Variations and progress in worksharing (Melanie Leivers)

Presentation - Variations - progress in worksharing CMDv comments (Esther Werner)

Presentation - Impact on administrative burden and fees (Rose-Marie Molina)

Presentation - EU Telematics strategy for veterinary medicines - Status update (David Mackay)

Presentation - EMA new premises (Agneta Brandt)