EMA and EATRIS Present: Scientific advice for advanced therapy medicinal products (ATMPs): what and when to ask

Date & Time 10 June 2022 at 13:00-14:00 CET
Location Online

This webinar takes its starting point in the training module “3.3 Scientific Advice for ATMPs” that can be accessed through the free of charge, self-paced online course. This module is a part of a comprehensive online course on ATMPs development pipeline designed by the ADVANCE Project.

Please note that in order to take the online module you will need to sign up/log in here (https://elearning.elevatehealth.eu/orderdirect/simple_enrol/1355) to gain access to the e-learning environment. If you are a first time user, please note that the login details will be sent to your email. It can take up to 15 minutes to receive them, and please do check your spam/junk email too as automatic emails often get stopped by improving filters. In case you have registered, but do not receive the login details please contact the support team at info@elevatehealth.eu.

Scope of the webinar is Scientific Advice for ATMPs and  Q&A covering the three areas of advice: quality, non-clinical and clinical development.

Webinar slides can be accessed and downloaded → HERE

Recording will be made available within a week through the ADVANCE Programme Youtube Playlist

Anna Tavridou, EMA

Anna holds a degree in pharmacy and obtained her MSc and PhD degrees in Newcastle University (UK). Her previous professional experience comes from an academic environment as well as the pharmaceutical industry. From 2004-2015, she held academic positions in the Department of Pharmacology in the Medical School of Democritus University of Thrace (Greece). Her research projects, focusing on the development of novel molecules with antiatherosclerotic properties as well as genetic epidemiology, led to several publications in peer-reviewed journals. In 2015, she joined the EMA Secretariat of the Scientific Advice Working Party and liaises with CAT in scientific advice procedures on ATMPs.

Milton Bonelli, EMA

Dr. Bonelli works in the Scientific advice office of EMA and also one of the EMA representatives in ICH. Before joining the Agency, his research activity, mostly in the field of molecular oncology and stem cells, focused on the use of patient-derived tumor samples for the development of drug screening assays, both for small molecules and radiopharmaceuticals. Since joining the EMA in 2011, he has worked in the non-clinical and clinical pharmacology area providing scientific analysis and support for initial Marketing Authorization and Scientific Advice procedures as well as input in other early drug development support initiatives of the EMA. He is a Doctor in Medicine (University of Rome Sapienza) specialised in clinical pharmacology and has published various articles accounting for his professional and research activities.

Dolca Rogers, EMA

Dr. Rogers works in the Pharmaceutical Quality Office of EMA. Before joining the Agency, she worked in research and development of new pharmaceutical products, for small molecules, antibodies and cell products. She also has experience in Regulatory Affairs in the pharmaceutical industry and as a consultant. Since joining the EMA in 2018, she has worked in the Pharmaceutical Quality Office providing scientific support for initial Marketing Authorisation, Variations and Scientific Advice procedures as well as input in support initiatives of the EMA with a special focus on ATMPs (ATMP Classification and Certification). She has a Master’s Degree (University of Barcelona) and a PhD in Chemistry (Queen Mary University of London).