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

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

2023 – When the CTR will be in force for all – Let’s be prepared

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 organisations and early phase service providers.  

Moderator: Izaak de Daas, QPS, The Netherlands

PROGRAM:

  • 16:00   Welcome and Introduction
  • 16:05   Regeneron’s EU Clinical Trial Regulation implementation experience & insights  + Q&A - Seán Kilbride, Magaly Woolard, Rishi Sarna; Regeneron
  • 16:45   Panel and Open Forum Discussion - Moderator: Izaak den Daas, QPS - PanelIsts: 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

PRICING:

Member ticets 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 seperately for this one. Here are the next two webinars:

  • 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

Register

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Prices

Ticket type Price
Webinar 16-09 member ticket € 30.00
Webinar 16-09 non-member ticket € 60.00

21% VAT will be applicable on the ticket prices

This event is organised by 2Mpact for EUFEMED.
You need to create your account on this website in order to be able to register for this event.

Invoices will be sent out by 2Mpact.

Company details:

2Mpact nv.
Kerkstraat 108
B-9050 Gentbrugge
Belgium
VAT BE0472134137

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