26 September 2016 EMA/621049/2016 Corporate Stakeholders Department

Report of first EMA-EFPIA annual bilateral meeting 16 September 2016, European Medicines Agency

Objectives of the meeting •

To provide an annual opportunity for EMA to engage individual industry stakeholder associations in dialogue on key areas of mutual interest, to share information, exchange views and enhance the EMA understanding of the needs and expectations of its stakeholders.

Topics addressed at the meeting Support for medicines development and market access •

EMA provided an update on recent experience with EMA’s “PRIME” initiative which was launched earlier this year. It was noted that a stakeholder meeting on PRIME will be organised by EMA in Q1 2017 once one year of experience has been gained with the scheme.



The recently published report from the Adaptive Pathways pilot was discussed. It was noted that a multi-stakeholders workshop on Adaptive Pathways will be held at EMA on the 8th December 2016 to discuss the learnings from the pilot and next steps. Discussions around the various development support mechanisms and regulatory tools for EMA early access to medicines took place with reference to the published overview of “Development support and regulatory tools for early access to medicines (EMA/531801/2015)”.



In the context of the ongoing EC review into the experience with Orphan and Paediatric incentives for medicines development, industry shared their views in response to the consultation.



Exchange of views regarding on-going implementing Commission legislative documents took place.



Finally a discussion took place on EMA-HTAs interaction early in development and the importance for industry of joint advice.

Implementation of recent legislation & IT telematics •

Both parties exchanged views on experience and challenges relating to the development of databases further to the implementation of falsified medicines, pharmacovigilance and clinical trial legislation. The high level business specifications and potential benefits and opportunities were discussed, as well as the involved partners/stakeholders, data standards and interdependencies. These discussions will continue to be coordinated through existing “technical fora” with all relevant

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

stakeholders, namely Member states, European Commission, EMA and Industry, where and as relevant. International Activity updates •

Both parties welcome the new ICH Reform and are looking forward to the extension of its membership, to facilitate global standard development and convergence, where and as appropriate. EFPIA highlighted potential challenges in maintaining efficiency and flexibility around such expansion but acknowledged the added benefits this may bring on topics such as scientific manufacturing standards, and regulatory capacity.



At the end of the meeting, EMA and EFPIA briefly discussed their recent engagement with emerging regulatory authorities. EMA also provided an update on ICMRA activities.

Interaction between the European Medicines Agency and industry stakeholders, namely EFPIA •

The implementation of the eligibility criteria for industry stakeholder associations and the launch of the application process (application form) for direct involvement in EMA activities were highlighted.



Further discussion on EMA and EFPIA specific Industry Stakeholders’ framework implementation will take place prior to the next annual meeting bilateral which is expected to take place around the same period in 2017.

EMA/621049/2016

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Participants List EMA

Guido Rasi Melanie Carr, Chair

Executive Director Head of Stakeholders and Communication ad interim, Head of Corporate Stakeholders

Marie-Hélène Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders

Enrica Alteri

Head of Human Medicines Research & Development Support

Peter Arlett

Head of Pharmacovigilance & Epidemiology

Michael Berntgen

Head of Product Development Scientific Support

Stefan Blixen-Finecke

Head of Head of Planning, Architecture and Quality ad interim

Francesca Cerreta

Scientific Advice

Emer Cooke

Head of International Affairs

Hans-Georg Eichler

Senior Medical Officer

Zaide Frias

Head of Human Medicines Evaluation

Jordi Llinares Garcia

Head of Scientific & Regulatory Management

Riccardo Luigetti

Principal International Affairs Officer

Stefano Marino

Head of Legal Department

Esther Martinez

Manufacturing and Quality Compliance

Jane Moseley

Scientific Advice

Francisco Fernandez Penaranda

Head of Business Data & Analytics

Cherif Radhouane

Head of Head of Telematics

Agnes Saint-Raymond

Head of Portfolio Board

Fergus Sweeney Spiros Vamvakas

EMA/621049/2016

Head of Inspections, Human Medicines Pharmacovigilance & Committees Head of Scientific Advice

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EFPIA

Richard Bergström

Director General

Sini Eskola

Director Regulatory Affairs

Pär Tellner

Director, Team Leader, Regulatory Affairs

Salah-dine Chibout

Member of IMI Board and Chair, EFPIA Innovative Medicines WG

Sue Forda

Chair, EFPIA Adaptive Models Priority WG

Edith Frenoy

Director HTA/REA

David Jefferys

EFPIA European Regulatory Expert WG

EMA/621049/2016

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Report of the first EMA-EFPIA annual bilateral meeting - European ...

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