EUFEMED 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 third Webinar on preparation for the new regulatory environment under the Clinical Trial Regulation
Under the Clinical Trial Regulation the reporting obligations of the sponsor are harmonised, strengthened and clearly defined. While SUSAR reporting will hopefully be less burdensome, there are now increased requirements to report serious breaches while performing the trial and additional obligations in reporting clinical trial results into CTIS and to the public. In this webinar we will present the new sponsor obligations and discuss strategies and first experiences on how best to fulfil them in clinical trials in early medicines development.
A detailed program will follow soon.
ATTENDANCE 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), and Polish Federation for Early Medicines Development (Polfemed – Poland).
This is the third of four 2022 EUFEMED webinars. If you have already registered for all four webinars, you do not have to register seperately for this one.
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. One of those founding associations was the Belgian Association for Phase-I Units (BAPU) – now HEALIXIA.
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 on www.eufemed.eu