Francesca Day is the Head of the Therapeutic Areas Department which comprises 6 TA-aligned offices. The department manages initial marketing authorisations as well as most post-approval lifecycle procedures. Prior to joining the Agency in 2020, Francesca worked in the pharmaceutical industry for over 20 years, ranging from SME to global Pharma, initially as a research chemist and then in regulatory affairs functions. Francesca holds a PhD in Chemistry.

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

Pedro holds a degree in Pharmaceutical Science (PharmD), a Master in Organic Chemistry from the University of Lisbon in collaboration with Imperial College in London and a PhD in Orphan drugs and Rare diseases from the University of Sheffield. Currently, he is working as a Director for Global Regulatory & Scientific Policy at Merck, mainly focus on regulatory intelligence, strategy and policy. He is the liaison for the China and Latam region concerning regulatory and policy topics. Previously, he worked at EMA for 12 years in different departments (regulatory affairs, assessment, authorisation of medicines, veterinary, orphan drugs, paediatrics, peer review and quality). Beforehand, he was working at INFARMED as a pharmaceutical assessor.

Enrico Tognana is Senior Business Intelligence Specialist coordinating the Business Analysis & Forecasting (BAF) activities at the European Medicines Agency. Prior to joining the Agency in 2008, Enrico worked in tissue engineering research and development both in academia and industry for over 10 years. Enrico is a biologist with PhD in Neuroscience.

Stefan is currently VP, Global RA-Regional Regulatory Leader-EMEA at Eli Lilly dividing his office time between Lilly’s Bracknell, UK and Bad Homburg, Germany. Stefan has leadership responsibilities for all of Lilly’s regulatory activities in EU, UK, CH, Middle East and Africa for both marketed & development products. He represents Lilly’s regulatory function on various internal governance committees including for global product labelling and international product development strategies. Stefan also represents the company at the EFPIA Innovation Board Sponsored Committee. After studying pharmacy at Johannes Gutenberg University, Mainz, D, he completed his PhD with honors from Ruprecht-Karls-University Heidelberg, Heidelberg, D.

Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009 and joined PRAC at its establishment in 2012. As a member of EMA’s GPAG (Granularity and Periodicity Advisory Group) and SMART WG (Signal Management Review Technical working group) and of CMDh’s PhV WSP WP (Pharmacovigilance Worksharing Procedures Working Party), he has a special interest in PSURs and PSUSAs, signal detection and management, and Risk Management Planning.

Lena Marletta is a project manager focused on the initial marketing authorisation process. This role involves portfolio management, resourcing and driving process improvements. Lena has been working for the Agency in various roles since 2005.

Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017, she was Head of Science Policy at the UK Trade Association (ABPI) and has worked on numerous policy issues relevant to the biopharmaceutical industry during her 8 years there. She is a Co-Chair of the FIFARMA’s Regulatory and Biologics Working Group and a member of the Expedited Pathways group in EFPIA. She was a post-doctoral scientist prior to her career in policy, with a PhD from Fitzwilliam College, University of Cambridge (UK) in cell signalling.

Günter Waxenecker, with a Master's in drug regulatory affairs, boasts 20+ years in drug development. Recognized for innovation and efficiency, he leads the Austrian Medicines and Medical Devices Agency since 2023, following key roles at Vienna SMEs and the Austrian Federal Office for Safety in Health Care. His expertise spans interdisciplinary know-how, cross-functional collaboration, change management, and international experience. As a lecturer at FH Campus Tulln, FH Joanneum Graz, and Vetmed Vienna, he shares his wealth of knowledge.