3rd EUFEMEDs Innovation Club Webinar
Reporting obligations under the Clinical trial Regulation: SUSARS, Serious Breaches, Summary of Trial Results and Lay Summary of trial results via CTIS
2023 – 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 prepara-tion 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.
A detailed program will follow soon.
ATTENDANCE FEES (excl. VAT):
- Member ticket: € 30.00
- Non-member ticket: € 60.00
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 Ap-plied Human Pharmacology (AGAH - Germany), Associatie van Contract Research Organisaties in Nederland (ACRON - Netherlands)