Agenda - European Medicines Agency veterinary medicines info day

2017 EMA Veterinary Medicines Info Day Organised in collaboration with IFAH-Europe

‘The latest developments' in scientific review, regulation and marketing authorisation procedures 16-17 March 2017, European Medicines Agency (EMA), London Final Programme Thursday 16th March 2017 13:30

Registration opens

14:00

Introduction and welcome

Session I: Scientific developments 14:10

Chair: Rick Clayton (IFAH-Europe)

CVMP achievements 2016: Highlights and reflections (30’) David Murphy (Chair of CVMP)

14:40

Anthelmintic resistance: Status including feedback from the focus group meeting 13 June 2016 and presentation on the CVMP Reflection paper (20’) Gesine Hahn (EU expert, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit)

15:00

Antimicrobial resistance (AMR): Presentation on the joint EMA/EFSA RONAFA opinion; harmonisation of SPCs of antimicrobial veterinary medicines under current legislation (20’) Helen Jukes (Chair of CVMP Antimicrobials working party)

15:20

Recent developments in environmental assessment (20’) Chris van den Eede (Zoetis/IFAH-Europe)

15:40

Questions (20’)

16:00

Coffee break (30’) – EMA info points

Session II: Availability of veterinary medicines 16:30

Chair: Fia Westerholm (EMA)

Vaccine availability: -

Action plan (20’)

Faye Ioannou (EMA)

-

Industry perspective (action plan and progress following 2015 workshop) (20’)

Frédéric Descamps (Zoetis/IFAH-Europe)

17:10

Impact of future legislation on availability (20’) Pablo Hervas (Veterindustria/IFAH-Europe)

17:50

Questions (20’)

18:00

Cocktail reception at The Pearson Room Restaurant, followed by walking buffet from 18:45

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5505 Send a question via our website www.ema.europa.eu/contact

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Friday 17th March 2017 Session III: Innovation 09:00

Chair: Roxane Feller (IFAH-Europe)

Horizon scanning: General outcome from meetings with industry; Early support for novel types of products (15’) Fia Westerholm (EMA)

09:15

Innovation: How to make legislation more supportive for innovation (15’) Peter Oostenbach (MSD/IFAH-Europe)

09:30

Update on ADVENT and progress on Q&A documents: experience with predrafting consultations (10’) Minna Leppänen (EMA)

09:40

Questions (15’)

Session IV: EU Procedural updates 09:55

Chair: Melanie Leivers (EMA)

Recent experiences with centralised procedure: opportunities for development (10’) Teresa Potter (EMA)

10:05

Best practice guide on adherence to timetables: status update (15’) Piotr Kozarewicz (EMA)

10:20

Questions (15’)

10.35

EMA procedural updates (15’) Emily Drury (EMA)

10:50

Questions (15’)

11:05

Coffee break (30’) – EMA info points

Session V: Regulatory policy 11:35

Future Legislation: harmonisation of SPCs: -

Industry viewpoint (15’)

Emmanuelle Royer (Caroline Toulemonde) (Merial/IFAH-Europe)

11:50

Questions (10’)

12:00

Future Legislation: pharmacovigilance:

12:40

Chair: David Mackay (EMA)

-

Pharmacovigilance and product data (20’)

-

Industry Vision (20’)

Jos Olaerts (EMA)

Tony Simon (Zoetis/IFAH-Europe)

Questions (10’)

Close of the meeting (5’)

2017 EMA Veterinary Medicines Info Day Organised in collaboration with IFAH-Europe EMA/595779/2016

Fia Westerholm (EMA); Rick Clayton (IFAH-Europe)

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