Maren von Fritschen is a recognized leader in Regulatory Affairs with 20+ years in Pharma and MedTech. With a PhD in Natural Sciences, she's now Head of Regulatory Policy Europe at Moderna, driving regulatory strategies for innovative technologies like mRNA. Maren built the regulatory arm at EUCOPE and was a foundational force behind PharmaLex, later founding AddOn Pharma as CEO. She's chaired DIA's Regional Advisory Council EMEA, contributed to TOPRA, and the STARS project. In the academic realm she is lecturing and mentoring master students at the University of Applied Sciences. Additionally, she has established a comprehensive scientific network across leading Universities in Brazil, focusing on medication in primary health care.

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

After working as a senior statistician in Pharma and UK medicines regulation, Karen Facey became the founding Chief Executive of the first national health technology assessment (HTA) agency in Scotland. For the past 15 years, Karen has been an independent consultant on health policy, HTA and patient involvement. She has a part-time role as Principal Investigator at the University of Edinburgh, leading a work package on appraisal of rare disease treatments in the EC H2020 funded IMPACT HTA project. Karen has facilitated the development of the multi-stakeholder initiative, RWE4ACCESS, under the leadership of the Belgian Payer, INAMI/RIZIV.

Claudio Santos is SVP, Head of Global Medical Affairs at PTC Therapeutics, based in New Jersey, USA. Pediatrician by training, with International Executive MBA, Claudio has developed his career as executive, for over twenty years, in multinational biopharmaceutical companies such as J&J, Wyeth, Pfizer, Shire and AMGEN; in PTC Therapeutics since 2017, he spearheads the Medical Affairs organization, including the Registry Studies and RWE Generation.

Regulatory professional and leader with many years of pharmaceutical industry experience in drug development & regulatory affairs with increasing level of responsibility. Led change processes in various teams successfully by engaging the relevant stakeholders in the decision-making process. Collaborated and influenced product development teams’ development strategy in various therapeutic areas including virology, oncology, CNS, metabolism, rare diseases. Negotiated successfully with health authorities during scientific advices, paediatric investigation plans and approval processes e.g. new products labels and during issue management.

Dr Gabaldo has more than 20 years of experience in drug development spanning from chemicals up to ATMP. Currently Vice President ATMP Global Regulatory Affairs at EVOTEC. Master degree in Pharmaceutical Chemistry and Technology and Master degree in Regulatory Affairs & Market Access for Chemicals and Biopharmaceuticas. Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. Currently member of the IRDIRC Regulatory Scientific Committee.

Andrew Olaye is Senior Director, Head of EMEA Market Access for Orchard Therapeutics, based in London, UK. A Pharmacist and Health Economist by training, Andrew has developed his career as a market access professional, for over 15 years, in multinational biopharmaceutical companies such as Pfizer, Grunenthal, Vertex and BioMarin. Prior to entering into market access, Andrew was a researcher in regenerative medicine at the University of Nottingham. In Orchard Therapeutics, he is responsible for coordinating the market access activities for Orchard across the EMEA region.

Sreeram (Ram) Ramagopalan is the Global Head for Real World Evidence for Market Access at Roche. Dr Ramagopalan’s team strategically plans and executes real world research studies to obtain access for Roche medicines. Dr Ramagopalan holds a PhD in Epidemiology from the University of Oxford, as well as an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. He is an international expert in real world evidence with over 260 peer reviewed publications.

Dr Hidalgo-Simon is currently head of Advanced Therapies in the European Medicines Agency (EMA). Previous positions include the head of the Specialised Scientific Disciplines Department, head of Signal Detection, and head of Risk Management, also at EMA. She has a degree in Medicine and Surgery from the University of the Basque Country, Spain, and a PhD from the University of London, UK. Additional qualifications include Health Economics (University of York) and Computing (University of Westminster).

Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality assessor of biologics including Advanced Therapy Medicinal products and she is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise in Clinical Trials, Non-interventional studies, scientific advice and compassionate use procedures reflect a strong interest in the development of biological medicinal products.

Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.