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.

Dr. Busch-Sørensen is a physician with 7 years of clinical practice mainly in internal medicine. Has passed the special module of Biostatistics & Epidemiology (part of Master of Public Health) as well as being bachelor of commerce in Marketing all at Copenhagen University. Dr. Busch-Sørensen has published multiple peer-reviewed manuscripts. Dr. Busch-Sørensen is serving as member of the board of the Danish Pharmacoepidemiology Society. He has been invited to speak on GVP, GPP, and Data Privacy as he has arranged and hosted multiple molecular profiling meetings between industry and academia. The IT angle in data privacy has been addressed extensively too, including validation of systems, ICH E15 implementation and training.

David has been involved with providing input to R&D from a patient perspective for more than 20 years. He has played an active role in the European Patients’ Academy on Therapeutic Innovation (EUPATI), and currently co-leads their external Advisory Committee. He is a past co-chair of the Patient and Consumer Working Party at the European Medicines Agency.Currently, is involved with Swissmedic’s Patients and Consumer Working Group, and he is a member of the PFMD Executive Committee, of the Zurich Cantonal Ethics Committee and the Impact Council for Gilde Healthcare. As a past member of the DIA Regional Advisory Council for EMEA, he was awarded the Outstanding Contribution to Global Health award in 2019.

In his current role within Sanofi’s Global Health Economic and Value Assessment group, Chris leads on the use of real world data to support market access over the lifecycle of medicines, including in development. He is the co-chair of the EFPIA Real World Evidence Community group. Chris graduated from Oxford University with a degree in Biochemistry; is a qualified chartered accountant and has a Masters in Health Economics from City University, London. Over the last 20 years he has also lead health outcomes groups and real world evidence projects at SmithKline Beecham, Lilly, and GlaxoSmithKline.

Estrid is a Clinical professor in molecular pathology at University of Copenhagen and Head of Molecular Unit, Department of Pathology. Furthermore she is director of the Nationwide Bio –and GenomeBank Denmark which include Danish CancerBiobank (DCB), Danish RheumatologyBiobank (DRB) and Danish BlooddonorBiobank (DBB). She established the Danish CancerBiobank in 2010, and has extended with several biobanks. She is responsible for the management, guideline description and programming of the database module. This leadership was a natural continuation of her position as head of the Gynecologic Cancer biobank group. More nationwide biobanks are planned with her as Director.

Hu Li, MBBS, Ph.D. is currently a principal research scientist at Eli Lilly & Company. She was trained in preventive medicine, Fudan University, China; and earned a doctoral degree in epidemiology, University of Pittsburg, USA. In the past decade, Dr. Li has accumulated extensive experience in pharmacovigilance and drug safety. She designed and led numerous observational research, evaluating various safety concerns. Dr. Li has particular interest in pregnancy research, and her expertise is recognized in conducting pregnancy registry studies as well as applying cutting-edged methodology using alternative approaches.

Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

Jane is part of Administration of Scientific Advice and Protocol Assistance procedures at EMA since 2009 including EMA HTA parallel scientific advice. She oversees EMA aspects of the launch of the new EMA EUnetHTA parallel consultation working closely with EUnetHTA. Jane is working in developing the concept of registries qualification advice at EMA in parallel with HTAs and gives scientific advice input to the EMA registries strategy. She has a background in ophthalmology, epidemiology and regulatory and has a medical degree from Trinity College, Dublin, FRCOphth and FRCSI(Ophth), and MSc in Epidemiology LSHTM. Previously, she was a medical assessor at the Medicines and Healthcare products regulatory Agency (MHRA) 1999-2009.

Heide is a Director of Epidemiology and a GSK Fellow in the RWE & Epidemiology department at GlaxoSmithKline. She is based in the UK, and has been working as an Epidemiologist in the pharmaceutical industry since 1999, providing Real World Evidence and observational research to inform decision making from drug discovery through all the various stages of lifecycle management. Her key areas of expertise include pharmaco-epidemiology, genetic epidemiology and statistical methodology. Recently, she has focussed on gene therapy research in rare diseases, and she has been developing an observational program that includes the creation of a registry to monitor safety and effectiveness of Strimvelis™ (first gene therapy for ADA SCID).

Bent Ejlertsen, MD, PhD, DMSc, is Medical Director of the Danish Breast Cancer Group and Consultant at the Breast Team, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark. Dr. Ejlertsen holds a major leadership role in national and international multicenter clinical trials. His main research interests include clinical research, evidence-based medicine, and translational research with focus on predictive factors and integration of genomics. He has published over 150 original papers and book chapters. Dr. Ejlertsen is a member of the DBCG Board of Directors, a member of the St. Gallen Consensus Panel, and is the Chairman of DBCGs Scientific Committee for Medical therapy.

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. As Principal, Drug and Biological Products, with Greenleaf Health, she offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

Dr. Aysim Yilmaz is Head of the Division Biology & Medicine of the Swiss National Science Foundation SNSF. She is a trained Medical Biology and Manager, who was active in research on tumor cell biology after her PhD , and then worked for Swiss Federal Offices before she joined the SNSF in 2001.

Dr Zimmermann joined Ipsen in January 2023 as SVP, Head of Regulatory & Quality R&D, based in France and since January 2024, SVP, Head of Global Regulatory Affairs. . She has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Before that, she held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. She serves currently as a Director in the Board of Inventiva Pharma.

Dr. Bo Terning Hansen obtained a PhD in biology at the University of Oslo, and is currently working as a researcher in the HPV Research Unit at the Cancer Registry of Norway. His research focuses on the epidemiology of diseases related to the Human papillomavirus (HPV), such as cervical cancer. He is involved in international projects that make use of several nationwide registries to assess the effectiveness of vaccination against HPV. His research also addresses cervical screening, as well as behavioral and socio-demographic factors that may correlate with HPV-related disease and its prevention.

Chay is Vice President for EUMEA Regulatory Affairs for BioMarin in London. He is responsible for the EU and MEA/CIS regional regulatory affairs teams supporting BioMarin’s online portfolio of orphan medicines for conditions including CLN2, MPS IVA, MPS VI, PKU, and LEMS, and development programs in rare conditions including Haemophilia, Achondroplasia, and MPS IIIB.