About EUFEMED webinar: Reporting obligations under the Clinical trial Regulation: SUSARS, Serious Breaches, Summary of Trial Results and Lay Summary of trial results via CTIS
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
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.
Program:
- 16:00 - Welcome and Introduction by Tim Hardman, President EUFEMED, AHPPI UK - Moderator: Izaak den Daas, QPS, ACRON, The Netherlands
- 16:05 - Reporting obligations for running trials under the Clinical Trial Regulation by Ingrid Klingmann, Pharmaplex, AGAH, Germany
- 16:30 - Sponsors’ reporting obligations on clinical trial results by Kerstin Breithaupt-Grögler, kbr, AGAH, Germany
- 16:55 - Panel and Open Forum Discussion - Moderator: Izaak den Daas, QPS, ACRON, The Netherlands - Panellists: Monique Al, CCMO, The Netherlands, Jelle Klein, SGS, Belgium, Kerstin Breithaupt-Grögler, kbr, AGAH, Germany, Ingrid Klingmann, Pharmaplex, AGAH, Germany, Thomas Smith, EUPATI Fellow, UK
- 17:30 - Conclusions
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.
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)