Regulatory Workshop for Universities

Added: 13th December 2015

We were approached to develop a workshop to introduce a large group of PhD students and university researchers from several UK universities to the regulatory environment for development of medical products in the EU. This request brought with it the challenge of explaining the regulatory frameworks for clinical trials and authorisation of medicinal products, human tissues and medical devices to a group very new to the concept of regulatory requirements. A large part of the workshop involved Q&As for a number of the participants' projects, so the ability to analyse quickly and explain clearly was a very important aspect of its successful delivery.

"Alison Wilson helped us put together a successful two day workshop intended for PhD students working in regenerative medicine.  The workshop was entitled “The Regulatory Route to the Clinic” and our aim was to show PhD students the guiding principles behind the regulatory environment and then help them apply these to some examples that they were interested in based on their own research.  The feedback on the workshop was excellent.  People found Alison approachable and helpful and that her common sense approach to tackling translational challenges was exactly what was needed. I can thoroughly recommend Alison as a consultant. She helps take the fear out of the regulatory environment and has great people skills. "

Sheila MacNeil - Professor of Tissue Engineering - University of Sheffield