099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson

Combinate Podcast - Combining Drugs and Devices

On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU -Working at MHRA as a Pre-Market Reviewer on Devices with an Ancillary Medicinal Substance -Notified Bodies, EU MDR and Article 117 -European Commission, Member States and European Member States Structure -Writing about combination products in the EU Janine is European Editor at IPQ (International Pharmaceutical Quality) Publications, living in Sweden and writing about the regulatory dialogue at biopharma conferences. She writes about quality/CMC issues, innovation and reliance, and drug-device combination products. Between 1997 and 2016, Janine was a pharmaceutical assessor at the UK MHRA, where she focused on device-drug combination products, working with several EU notified bodies, and with MHRA colleagues on drug-device combination products and borderline classification issues. She helped with training, set up a cross-agency combination product working group, and was involved in horizon scanning and innovation office activities at MHRA and EMA. She has also been an enthusiastic contributor to TOPRA, The Organization for Professionals in Regulatory Affairs, from special interest networks to training and chairing conference sessions.