STARS Global Conference Excellence in Regulatory Science
This event brought together leaders in regulatory science. Its goal was to stimulate discussion across all stakeholders and to critically consider lessons learned and recommendations from the STARS project that address regulatory support and the regulatory readiness of academia. Presentations now available!
TIME: Thursday, 19 May 2022 | 13.00-21.00 CEST
VENUE: The EGG, Brussels, Belgium
LINK: link to online participation (expired)
About this event:
This event brought together leaders in regulatory science. Its goal was to stimulate discussion across all stakeholders and to critically consider lessons learned and recommendations from the STARS project that address regulatory support and the regulatory readiness of academia.
The event was also used as a platform to discuss concepts on how to initiate collaborative regulatory science research in the future.
Joining the congress enabled participants to actively contribute to concepts on how academia-driven health innovations can be advanced more efficiently. The event also provided ample opportunities for networking between all stakeholders, including regulators, academia, funders, policy makers, industry and patient representatives.
Agenda and Presentations
Please click title to download an individual presentation (disclaimer).
You can also download all presentations as a single ZIP-file.
| Time | Title | Speaker | Institution |
|---|---|---|---|
| 11.00 – 13.00 | Registration and get-together Welcome drinks and snacks |
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| 13.00 – 14.45 | PART I CSA STARS: Major achievement and presentation of the Common Strategy Chair: Wiebke Löbker (BfArm) |
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| 13.00 – 13.15 | Welcome address | ||
| 13.15 – 13.30 | Regulatory Challenges and Support Needs in Academic Drug Discovery and Development – Insights from the STARS Survey Study | Viktoriia Starokozhko | MEB, The Netherlands |
| 13.30 – 13.45 | Strengthening Regulatory Science: STARS Core and Comprehensive Curricula | Eleonora Agricola | AIFA, Italy |
| 13.45 – 14.00 | STARS Pilots: Implementation of a best practice, novel support activity and the curriculum | Yoana Nuevo | AEMPS, Spain |
| 14.00 – 14.15 | Pre-grant regulatory scientific advice – Insights into a Novel Concept | Bettina Ziegele | PEI, Germany |
| 14.15 – 14.45 | STARS Common Strategy: Regulatory Support and Advice for Academia | Anne Heß | BfArM, Germany |
| 14.45 – 15.00 | Coffee break | ||
| 15.00 – 18.30 | PART II Facilitating the Translation of Academic Research into Clinical Practice – How to Move Forward Chair: Laurence O’Dwyer (HPRA, Ireland), Falk Ehmann (EMA) |
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| 15.00 – 16.30 | |||
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Impulse Talks with perspectives and experiences on the STARS Common Strategy (click name of speaker to download presentation) |
Carla Hollak | Amsterdam UMC, The Netherlands | |
| Cecile Ollivier | Critical Path Institute Europe, The Netherlands | ||
| Christine Mayer-Nicolai | European Federation of Pharmaceutical Industries and Associations, Belgium | ||
| Susan Winckler | Reagan-Udall Foundation, United States | ||
| Evelyn Depoortere | European Commission, Directorate-General for Research and Innovation, Belgium | ||
| Kristof Bonnarens | European Commission, Directorate-General for Health, Belgium | ||
| Rabia Hussain | University College Dublin, Ireland | ||
| 16.30 – 16.45 | Coffee break | ||
| 16.45 – 18.00 | Panel Discussion: Concepts to support the interaction and collaborative communication between academia and regulators: | ||
| Academic medicines developers needs | Carla Hollak | Amsterdam UMC, Netherlands | |
| Academic medicines developers needs | Rabia Hussain | University College Dublin, Ireland | |
| Incorporating regulatory considerations into academic research | David Morrow | EATRIS | |
| Regulatory science research needs | Ralf Herold | EMA | |
| The role of funders | tba | tba | |
| Accelerating Clinical Trials in the EU (ACT EU) | Greet Musch | FAMHP, Belgium | |
| Regulatory tools and resources for academics – the ReGARDD initiative | Lauren Kanigher | Virginia Commonwealth University, US | |
| 18.00 – 18.15 | Academia and Regulators – Stronger together. Lessons learned from COVID 19 | Harald Enzmann | BfArM, Germany; Chairperson of Committee for Medicinal Products for Human Use |
| 18.15 – 18.30 | Closing remarks and outlook | Wiebke Löbker | BfArM, Germany |
| 18.30 – 21.00 | PART III Networking with dinner |
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Download agenda (PDF)
