16 September 2022, 16:00-17:30 CET
Submitting an application for a CTA and what do sponsors from outside the EU need to consider?

Your registration is still welcome and possible

EUFEMED’s Innovation Club is inviting you to the second Webinar on preparation for the new regulatory environment under the Clinical Trial Regulation

Under the Clinical Trial Regulation the clinical trial authorisation application has to occur in a new process: a “Single Dossier” has to be submitted to the “Single Portal” of CTIS (EU Clinical Trial Information System). Sponsors have to respond within a few days to deficiencies in the validation process and to “Requests for Further Information”. Access to CTIS, the dossier preparation and submission, and the decision making process on further information to be submitted require a very detailed planning and agreement between sponsor and clinical trial unit/CRO on responsibilities and oversight. In this webinar we will discuss strategies and first experiences on efficient collaboration between international sponsor organisati-ons and early phase service providers.

Moderator: Izaak de Daas, QPS, The Netherlands


16:00  Welcome and Introduction
16:05  Regeneron’s EU Clinical Trial Regulation implementation experience and insights + Q&A – Seán Kilbride, Magaly Woolard, Rishi Sarna; Regeneron
16:45  Panel and Open Forum Discussion

Moderator: Izaak den Daas, QPS
Panellists: Magaly Woolard (Regeneron, UK), Sean Kilbride (Regeneron, UK),
Nina Berberich (Morphosys, DE), Anne Jacquet (Eurofins Optimed, FR),
Cynthia Lesbros (Eurofins Optimed, FR), Mariska Beukers (QPS, NL)

17:25 Closing remarks
17:30 End of the Webinar

FEES (excl. VAT):

Member ticket:         € 30.00
Non-member ticket:  € 60.00

Member tickets are available for members of: Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI – UK), Healixia (Belgium), Association Française de Pharmacologie Translationnelle (AFPT – France), Association for Applied Human Pharmacology (AGAH – Germany), Associatie van Contract Research Organisaties in Nederland (ACRON – Netherlands)


This is the second of four 2022 EUFEMED webinars. If you have already registered for all four webinars, you do not have to register again. Save the date for the next two events:

4 November 2022 (16:00 – 17:30 CET): Reporting obligations under the
Clinical trial Regulation: SUSARS, Serious Breaches, Summary of Trial
Results and Lay Summary of trial results via CTIS

9 December 2022 (16:00 – 17:30 CET): Christmas Lecture: Latest
innovations in early medicines development


The European Federation for Exploratory Medicines Development (EUFEMED) was founded in 2015 as a result of an ongoing, informal collaboration between several European societies active in the area of human pharmacology.

EUFEMED is a not-for-profit association established under the Belgian law. The mission statement of the federation addresses the development, protection and promotion of the interests of early clinical medicines research and development in Europe.

Read more at: www.eufemed.eu

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