Agenda & Presenters:
> Basic introduction to regulatory requirements for IDMC / Seif Eddine Amara Madi, GSK Biologicals
> Common findings relating to IDMC/DSMB during audits and inspections / Louise Mawer, Mirabilitas Ltd
> Main challenges for IDMC expert during COVID-19 / Stephen Toovey, Pegasus Medical & Scientific Services
> IDMCs/DSMBs: a short research ethics primer / Heather Sampson, University of Toronto
> Main challenge for IDMC management a sponsor perspective (TBC)
> Q&A, Discussions
This year, in 2020, 13 years after the EU Paediatric Regulation came into force, our aim is to build on achievements and lessons learnt so far and to look at the future of paediatric drug development, with a specific focus on putting patients at the heart of innovation and regulatory science.
Country comparison of the effects of the pandemic on clinical research - Lessons learned. Representatives from different countries will present their experiences in different functions in clinical trials.
Our Free of Charge weekly Q&A Webinars on Clinical Trials During the Corona Virus Pandemic are continuing! Quality and ethics experts respond to your questions from sponsor and site points of view.