09:30 – 11:00: SME - Regulatory Updates for SME, Academia and Start-ups
Small and medium sized companies (SMEs), Academia and Start-ups meet different regulatory challenges when developing the life science products of the future to meet patients’ needs. This day is to explore regulatory news, to receive an update on recent changes and also to understand the support available and provided to SMEs, Academia and Start-ups.
There will be opportunities to hear directly from the European Medicines Agency (EMA) and the Paul-Ehrlich-Institut (PEI), Germany, on the support they can offer, along with practical examples on navigating the regulatory system and extensive time to network with colleagues and regulators.
09.30-09.35: Introduction
Chair: Margareth Jorvid, Methra Uppsala AB, Sweden
09.35-09.55: European Medicines Agency - Support to SMEs and Academia
Leonor Enes, EMA, SME Office, the Netherlands
- Support to SMEs - SME Office
- Support to academia
- EMA support to innovation
09.55-10.15: Local support from PEI to Academia and Start-ups
Nadine Kirsh-Stefan, Paul-Ehrlich-Institut, Germany
- How to prepare for and contact the Agency
- National scientific advice
- Experience of national support
10.15-10.25: The regulatory experience of a SME, industry perspective
Elaine Morten, Actimed Therapeutics Ltd, United Kingdom
- When to talk to the Regulators?
- Meetings with National Agencies, EMA and FDA
- Practical experiences
10.25-11.00: Panel discussion
Session Lead:
Speakers will include:
Leonor Enes
Scientific Officer -
SME Office, EMA,
The Netherlands |
Nadine Kirsch-Stefan
Head of DZIF Office for Scientific
and Regulatory Advice (OSRA), Paul-Ehrlich-Institut,
Germany |
Elaine Morten
Head of Regulatory Affairs and Technical Development
Actimed Therapeutics Ltd, United Kingdom |
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To view the programmes for the sessions running alongside the SME session, look through the relevant programme tab at the top of this page.
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Time
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SME and Academia
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Human Medicines
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Parallel Sessions |
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09:00 - 09:30
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Registration
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09:30 - 11:00
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SME: Regulatory Updates for SME, Academia and Start-Ups
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HM8: ePI is on FHIR: Preparing for Implementation
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11:00 - 11:30
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Networking break
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11:30 - 13:00
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Delegates can choose from one of the following:
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HM9: From Barrier to Bridge: Practical Strategies for Successful Advanced Therapy Medicinal Product (ATMP) Development
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PS1: Tailored development of biosimilars without efficacy and safety studies: is this the future? |
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13:00 - 14:15
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Lunch
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14:15 - 15:45
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Delegates can choose from one of the following:
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HM10: Strengthening Europe’s Clinical Trial Competitiveness
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PS2: Navigating the Green Horizon: Environmental Sustainability and Regulatory Affairs |
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15:45
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End of Symposium
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