Clinical Trial Science and Regulations
Chair: Kirsty Wydenbach
A large number of the FPM members work in clinical research, across the phases of medicines development and discovery. The Clinical Trial Science and Regulations Expert Group proactively follows relevant trends in global clinical development matters, including regulatory changes. This includes issues arising from differences in guidance between global regulatory authorities and ICH, as well as other local (UK) and global development ecosystem issues. The group considers draft regulatory guidances, policies or other stakeholder materials on clinical development matters, including horizon scanning for future significant changes. The group also co-ordinates responses to regulatory consultations and works closely with other expert groups on key topics.