Janine Jamieson

IPQ Publications

Janine is European Editor at IPQ Publications, media partner to CASSS. Previously, she was a pharmaceutical assessor in the Medicines Licensing Division of the UK Medicines and Healthcare products Regulatory Agency (MHRA) from 1997 until June 2016; the latter 10 years with focus on device-drug combination (DDC) products, carrying out consultations for several EU Notified Bodies. She was involved in advising on drug-device combination product and borderline issues, working closely with MHRA Devices colleagues, training and setting up a cross-agency combination product working group; also involved in horizon scanning and EU-Innovation office Network activities.

Since 2016, Janine has learned about the challenges industry face in the borderline and combination product arena from consultancy work and now focuses full time on sharing the regualtory dialogue at conferences. Her special areas of interest are combination products, innovation in regulation and biopharmaceutical manufactuure, and global regulatory reliance, recognition and worksharing.

She has contributed to book chapters on international combination product regulations, industry group reflection papers and organised training courses, inter-regulatory and stakeholder workshops and joint pharma/device sessions at conferences for The Organisation for Professionals in Regulatory Affairs (TOPRA)