Quality & Regulatory Requirements For Drug Device Combination Products - EU edition MasterClass

Dr. Tina Amini, a Pharmacist with a PhD in Pharmaceutics was director of the medical device division at NDA Group AB till recently where she supported MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products for EU, UK and US market access.

Tina formerly held the positions of Head of Notified Body, CE Certification Authority and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor.

She was also involved in the classification of borderline products, EU pre-submission scientific advice procedures for medical devices, the consultation process with several EU competent authorities and EMA for device/drug products. She was a member of Team-NB Working Group: Borderline issues and new technologies, Classification and borderline; Post Market and Clinical. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry on the development of medicinal products and combination products in several therapeutic areas for over 17 years.