EMA veterinary medicines innovation day Thursday, 19 April 2018 European Medicines Agency London, United Kingdom

About this event The objective of this meeting is to further raise awareness of the support available to facilitate innovation of veterinary medicines by giving an overview of the legislative framework and by describing the support offered by the EMA and interactions with stakeholders. This event is open to all companies and stakeholders developing veterinary medicinal products.

Arrival at the Agency and registration On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry lounge is located through the sliding doors to the right of the reception desk past the security turnstiles. Your EMA contact point will meet you there. We strongly advise you to arrive up to 30 minutes before the start of the info day, to allow you time for registration. Please note that the Agency requires all visitors to provide a valid photo ID on arrival, such as passport, identity card or driving licence. Participants without a valid photo ID may be turned away.

Media disclaimer The Agency records or broadcasts a number of its meetings, including some virtual meetings. This is part of the Agency’s commitment to the principle of transparency as enshrined in the Treaty on European Union. The Agency herewith informs attendees that this particular meeting will be recorded and broadcast. For more information about processing of personal data by EMA, please visit the EMA website or contact: [email protected] By attending this meeting you consent to any recording or broadcast.

Venue European Medicines Agency 30 Churchill Place Canary Wharf, London E14 5EU United Kingdom

Telephone +44 (0)20 3660 7099 E-mail: [email protected] Website: www.ema.europa.eu

EMA veterinary medicines innovation day - Agenda 13:30-17:45, Meeting Room: 3A and 3M 1.

Registration / 13:00-13:30 Chair: I. Claassen, Head of EMA Veterinary Division Welcome and opening remarks / 13:30-13:40 Session 1: EU legislative framework for veterinary medicinal products

2.

EC perspective on innovation in veterinary medicinal product development Impact of new veterinary regulation in innovation Speaker: C. Siebert, EC / 13:40-14:10

3.

Promoting innovation through the veterinary regulatory framework: Role of EMA

4.

Questions and answers / 14:30-14:40

Speaker: D. Mackay, EMA / 14:10-14:30

Session 2: EMA interactions to support innovative medicines 5.

Introduction to SME incentives

6.

Advantages of Minor Use Minor Species (MUMS) classification to innovative products

7.

Innovation Task Force and ITF briefing meetings: What can be gained

Speaker: H. Casaert, EMA / 14:40-14:55

Speaker: M. Jakava-Viljanen, EMA / 14:55-15:10

Speaker: M. Leppänen, EMA / 15:10-15:25

8.

How scientific advice procedure can support innovation

9.

Questions and answers / 15:40-15:55

Speaker: R. Breathnach, CVMP, SAWP-V Chair / 15:25-15:40

Break / 15:55-16:15 Chair: David Murphy, CVMP Session 3: Interactions with Stakeholders 10. EMA –Academia collaboration framework Speaker: M. Ensini, EMA / 16:15-16:30

11. Role of ADVENT in innovation support

Speaker: E. Werner, CVMP, ADVENT, IWP Chair / 16:30-16:45

12. Stakeholder interaction in EMA innovation support Speaker: I. Claassen, EMA / 16:45-17:00

13. Experience of EMA innovation support from a stakeholder perspective

Speakers: S. Arnouts, PROVAXS – Ghent University; A.Pradera, Equicord Ymas S.L. / 17:00-17:20

14. AMEG’s proposal for an Early Hazard Characterisation to encourage the development of novel antimicrobial VMPs Speaker: H. Jukes, CVMP vice-chair. AWP chair / 17:20-17:30

15. Questions and answers / 17:30-17:45 Closing remarks by chairs / 17:45 On 20 April 2018, the European Medicines Agency will give an update on Brexit regulatory preparedness activities during another session organised for veterinary companies. Participants attending the Innovation Day will also be welcome at this meeting.

www.ema.europa.eu/vet

Agenda - European Medicines Agency veterinary medicines ...

On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry lounge is located through the sliding doors to the right of the reception desk past.

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