15 May 2018 EMA/195267/2018

Agenda – Industry stakeholder platform on research and development support 18 May 2018 10:30 – 17:00, Meeting room 03-F

Chair: Michael Berntgen Item

1.

Agenda

Time

Welcome / Introductions

15 min

Overview of the agenda Enrica Alteri, EMA 2.

Exchange on experience with the implementation of the Orphan notice

30 min

Experience and developments based on the reviews by COMP over the first year Kristina Larsson, EMA Challenges from industry perspective, particularly for the reassessment in the context of an extension of indication Maren von Fritschen and James Barnes, EUCOPE Discussion 3.

Targeting “histology-independent indications” and resulting challenges

30 min

in the context of orphan designations Experience from developers when discussing such development programmes Isabelle Stöckert, EFPIA Discussion, including update from the workshop as well as COMP experience Francesco Pignatti and Kristina Larsson, EMA

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4.

Introduction to the upcoming rollout of the new technology to support

45 min

orphan designation procedures (S-REPS) Presentation of the new CRM tool including live demo Paolo Tomasi, Sylvie Beausuroy and Bob Coggins, EMA Feedback from industry representatives from the user group Olaf Mengels and Danuta Wawrzak, EBE-EFPIA Discussion 5.

Experience with the review of digital technology proposals in medicine

45 min

development programmes Orientation and overview of developments in this field and needs for future engagement with regulators and other decision makers Mark Hope and Chris Walker, EFPIA Experience in scientific advice and qualification, and initial learnings for future activities Spiros Vamvakas and Francesca Cerreta, EMA Discussion on priorities for upcoming exchange in this space (also involving Marisa Papaluca and Alison Cave, EMA)

6.

Lunch

60 min

Evolving framework for the co-development of medicinal products with

45 min

companion diagnostics Status update on the developments in the implementation activities of the MDR/IVDR Armin Ritzhaupt, EMA Scientific proposals coming into the regulatory system: Identified critical issues for the (co-) development of companion diagnostics and medicinal products Falk Ehmann, EMA Considerations from developer’s perspective on the opportunities for alignment of development between drugs and diagnostics Christine Mayer-Nicolai and Claudia Dollins, EBE-EFPIA Discussion (with participation of Oliver Bisazza and Petra Zoellner, MedTech Europe, as observers)

Agenda – Industry stakeholder platform on research and development support EMA/195267/2018

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7.

Understanding which technologies are coming into the healthcare

20 min

systems Considerations from discussions across decision makers (regulator, HTA, payer) Michael Berntgen, EMA, together with Cláudia Furtado, INFARMED, Ingvil von Mehren Sæterdal, NIPH, as well as Ad Schuurman, Wytse Bruinsma, and Niels Speksnijder, ZIN Discussion (also with Enrico Tognana and Marisa Papaluca, EMA) 8.

Focus group “Post-licensing evidence generation”

20 min

Scope and methodology to progress with this focus group Jane Moseley, EMA / Emma Du Four, EFPIA 9.

Follow-up from the EC/EMA workshop on paediatrics

30 min

Summary of the outcome and next steps; recent experiences in the field of paediatrics with regard to extrapolation and international collaboration Ralph Bax, EMA Industry reflections on the workshop and priority areas Industry Angelika Joos and Genevieve Le Visage, EFPIA Discussion 10. Update on PRIME

30 min

Overview of updated guidance based on experience and learnings after 2 years of operation of the scheme Jordi Llinares and Zahra Hanaizi, EMA 11. Summary of follow-up items

15 min

Close of meeting Michael Berntgen, EMA

Agenda – Industry stakeholder platform on research and development support EMA/195267/2018

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Agenda - European Medicines Agency - Europa EU

May 15, 2018 - Mark Hope and Chris Walker, EFPIA. Experience in ... Jordi Llinares and Zahra Hanaizi, EMA. 30 min. 11. Summary of follow-up items. Close of ...

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