International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical MedicinePlease note that this webinar, a special virtual Workshop following the webinar of 30th June 2025 on the ICH – GCP Revision, will start half-an-hour later than announced, i.e. at 11:00 am CEST (instead of 10:30 am CEST) on 18th September 2025. It will end at 15:30 CEST
Performing ICH-GCP-compliant clinical trials remained to be a challenge, especially for academia and small and medium-sized enterprises but also for big pharma and investigators who often complained about an over-complicated quality framework, especially for late-phase and Phase-4 trials. The newly implemented R3 version requires from sponsor and investigator to decide how GCP requirements have to be applied in a way that is proportionate to the risks in this trial concerning participant protection, data reliability and scientific integrity. After the presentation of the new concepts and strategies of the R3 version in the webinar of 30the June 2025, this follow-up ICH-GCP(R3) workshop will provide the opportunity to learn about and discuss how these new strategies are to be implemented in your clinical trial.
For all agenda items there will be an introduction followed by discussions
Faculty:
Ingrid Klingmann, MD, PhD, PharmaTrain, Belgium
Elisabeth Reus, Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland
11:00 – Welcome and Introduction
11:05 – Why is ICH-GCP(R3) requiring a mind shift in applying it to clinical trials?
- Quality by design
- Risk-proportionate approaches to all processes in trial preparation and conduct
- Need for awareness and application of all ICH efficacy guidelines
11:50 – What does “Quality by design” and “Critical to quality factors” mean in practice in your trial
12:20 – How to assess and decide on “risks” in your clinical trial and what does “risk proportionate” mean in practice?
13:00 – Break
13:30 – How to decide on required qualification and training needs?
13:45 – How to enable reliable and seamless responsibility allocation and oversight between sponsor, service provider and investigator according to (R3), also in decentralised trials?
14:35 – How to handle ethical aspects in relation to the Declaration of Helsinki and on eConsent?
15:00 – How to apply the new Chapter 4 on governance for sponsors and investigators?
15:30 – End of the Workshop
Register at the link below and ensure that you click on the date of 18th September 2025 which will open the registration for this workshop at 25.00 € in case you have not registered before for both webinars: https://www.eventbrite.com/e/ich-gcpr3revision-webinar-plus-workshop-tickets-1356963718009?aff=ebdsshcopyurl&utm-campaign=social&utm-content=attendeeshare&utm-medium=discovery&utm-term=listing&utm-source=cp
