Molecular biologist (MSc) by training. Currently based in Basel, Switzerland and part of the team responsible for regulatory intelligence and policy for the EU for Novartis. Supporting project teams in establishing their strategy for filing and responding to their regulatory questions. Daily organisation of regulatory intelligence activities and analytics (e.g preparation of newsletters and communications, benchmarking). Coordinator and owner of the commenting process on draft EU guidance. Point of contact for external and internal tools required for data submission.

Bettina started her career as a regulatory professional in the pharmaceutical industry more than 20 years ago. In global as well as European regional roles in headquarters of several pharmaceutical companies, she gathered comprehensive experience in the areas of drug development, clinical research, and the management of regulatory procedures, as well as a strong knowledge base of the regulatory environment. Her experience includes working actively with Industry Associations, consortia, and the EU RING, and providing relevant input in the monitoring, review, commenting and impact assessment of regulations and guidelines. She is currently working at CSL Behring GmbH in Marburg/Germany as Global Lead Regulatory Intelligence and Policy.

João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory Intelligence & Policy, notably at Lundbeck and Takeda, where he worked to help colleagues to better understand the shifting regulatory environment and to support drug development in several therapeutic areas globally. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee.

Pharmacist by training, Bertrand started his career as a regulatory professional in the bio-pharma industry more than 20 years ago. He held various positions in national, regional and global RA departments, in several companies such as 3M Pharmaceuticals, Baxter and Janssen. He gathered comprehensive experience in the areas of drug development, clinical trials and pre-approval interactions with Health Authorities as well as a strong knowledge base of the of the EU and global regulatory landscape. Since 2019, Bertrand is leading the Regulatory Policy & Intelligence function at Shionogi Europe. He is representing his company at the EU Trade Association EUCOPE where he is co-leading the Clinical Trial Focus Group.