16.09.2022: Webinar – When the CTR will be in force for all

Submitting an application for a CTA and what do sponsors from outside the EU need to consider

Webinar on 16 September 2022 at 16:00-17:30 CET

16.09.2022: Webinar – When the CTR will be in force for all

When the CTR will be in force for all – Let’s be prepared

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 one portal (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 organisations and early phase service providers.

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Moderator: Izaak de Daas, QPS, The Netherlands

Program:

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: Speakers and different European stakeholders
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)

Register now

We look forward to your registration!