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

EventCorporateMedicines

Date

Thursday, 13 March 2014, All day

Location

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

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

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

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Presentation - CVMP work plan 2014 (Anja Holm)

English (EN) (948.46 KB - PDF)

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

English (EN) (732.43 KB - PDF)

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

English (EN) (797.2 KB - PDF)

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

English (EN) (275.21 KB - PDF)

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

English (EN) (196.68 KB - PDF)

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

English (EN) (146.26 KB - PDF)

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

English (EN) (138.96 KB - PDF)

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Presentation - Clarification of MUMS policy (David Murphy)

English (EN) (146.18 KB - PDF)

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

English (EN) (229.03 KB - PDF)

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Presentation - Packaging and labelling (Johann M. Lenhardsson)

English (EN) (717.63 KB - PDF)

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

English (EN) (982.58 KB - PDF)

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

English (EN) (149.65 KB - PDF)

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Presentation - Variations and progress in worksharing (Melanie Leivers)

English (EN) (1.24 MB - PDF)

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

English (EN) (118.14 KB - PDF)

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

English (EN) (236.24 KB - PDF)

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

English (EN) (298.76 KB - PDF)

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Presentation - EMA new premises (Agneta Brandt)

English (EN) (2.98 MB - PDF)

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