German Pharmacovigilance Day - Speakers

Dr. Carsten Wieser studied pharmacy at the University of Regensburg. He then worked – as part of his dissertation – at the Institute for Clinical and Molecular Virology in Erlangen. He began his professional career as a Medical Expert Drug Safety at Novartis Pharma GmbH in Nuremberg. From 2009 to June 2022, Dr. Wieser held various positions of increasing responsibility at Grünenthal GmbH, most recently as Director Regulatory Affairs & Drug Safety DACH. Since July 2022, Dr Wieser has been Deputy General Manager Quality, Regulatory & Safety at Mitsubishi Tanabe GmbH. Starting from August 2023, he is Head Global Safety at Dr Falk Pharma.

Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 15 years. He supports R&D divisions to improve their business processes through the optimized use of information technology.

Today Marc is Principal Consultant at Insife. His main fields of expertise are business processes and applications for pharmacovigilance, supported by proven knowledge in international team leadership, project management, computerized systems validation, and business intelligence.

Prior to his consulting career Marc headed the Drug Safety IT and Application Management groups at UCB and Grünenthal, respectively. In these roles he was the project leader for the implementation or upgrade of Pharmacovigilance IT systems, with experience in designing and implementing signal detection and management systems.

As an expat for Schwarz Biosciences Inc. (USA), Marc Zittartz gained experience in a cross-cultural environment as well as in clinical development.

The cross-border insights into both clinical development and regulatory affairs gives Marc a unique perspective and enables him to advice clients in the process of choosing and implementing the right solutions to optimize their PV.

Immunologist & Pharmacovigilance Professional with extensive knowledge in global legislations and guidelines (Pharmacovigilance, Clinical Development, and Regulatory/Medical Affairs). Over a decade-long experience in supporting and fulfilling pivotal roles such as EEA QPPV and RPPV in Clinical Trials. With a career spanning over 25 years which included academia, pharmaceutical industry, regulatory authority, CRO, and Start-up.

Dr. phil. nat. Meik Helmut Behrens holds the position of Regional Head of Global Patient Safety for Western Europe at Merck Healthcare KGaA. With over two decades of experience in drug safety and pharmacovigilance, he has held senior roles at organizations such as Reckitt Benckiser, Horizon Pharma, and ICON Clinical Research. His career is marked by expertise in developing and enhancing pharmacovigilance systems, ensuring regulatory compliance, and quality management. Dr. Behrens holds a Doctoral degree in Biology from Johann Wolfgang Goethe University Frankfurt and additionally certified knowledge in Pharmaceutical Medicine. He is an active member of the German Society for Pharmaceutical Medicine (DGPharMed) and its pharmacovigilance working group.

Dr Martin Huber is the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Since October 2018 he is the vice-chair of the PRAC. In addition, he is also chairing the Non-prescription medicinal products Task Force of the CMDh since May 2017.
Being a pharmacist by training and holding a degree in public health he gathered comprehensive experience in pharmacovigilance in a hospital setting both in Germany and Switzerland before entering BfArM in 2010. Since 2013 he has been head of the unit ‘PRAC and other Committees’, and since 2017 he is head of the unit ‘PRAC, Legal Status, Adverse Reaction Reports, Medication Errors’ within BfArM’s division of pharmacovigilance.

With 15 years of independent leadership experience in Germany and a decade in post-graduate academia, I offer clinical-scientific and pharmacovigilance expertise to national Health Authorities in various European countries. I have pursued, to the best of my efforts, a path of excellence throughout a patient-centric career. I am specialized in local surveillance, causality assessments of suspected adverse drug reactions, independent risk/benefit evaluations of medical therapies, and have a thorough knowledge of large, complex analytical systems. I understand University and Healthcare dynamics, and the interdependence of its stakeholders. As a Alumni of the Mayo Clinic USA (ONCL02) with experience in student mentoring, I have contributed to a wide range of strategic initiatives aimed at the development of international student exchange and education, and have worked extensively with colleagues across Germany, Austria, and Switzerland.

Reinhold Schilling, M.D.R.A. is an experienced leader in Global Pharmacovigilance, currently serving as Head of Global Pharmacovigilance & EU QPPV at Wörwag Pharma. With over seven years of leadership experience, he oversees risk management activities, patient safety compliance, and regulatory commitments.

In his role, Reinhold develops strategies, optimizes processes, and fosters strong leadership within his team. He is passionate about mentoring young professionals, regularly integrating interns and graduate students into his department, where they gain both technical and management skills.

Before joining Wörwag Pharma, Reinhold held various positions in Pharmacovigilance and Drug Safety, building extensive expertise in case management, signal detection, and safety report authoring.

Maria studied Pharmacy at the University of Bath, with a Master’s thesis in Pharmacoepidemiology, and also holds a Master’s Degree in Epidemiology from London School of Hygiene & Tropical Medicine. She started her PV career at STADA more than 10 years ago, with focus on signal and risk management. Since moving to Grünenthal in 2017, Maria held various positions of increasing responsibility, acting as Global Safety Lead for various clinical and post-marketing assets and more recently taking on the position as Head Safety & Benefit Risk. Maria’s interests include pharmacoepidemiology, signal detection methods, as well as application of new technologies, systems and tools in these areas. Through her various positions, she also has extensive knowledge and experience in the areas of periodic reports, risk management and solicited data collection.

Dr. Heinz Weidenthaler is a physician, currently employed as Safety Strategy Lead at BioNTech SE. He graduated from Technical University of Munich Medical School in 2000 and completed his MD thesis in immuno-oncology in 2003. In 2022, he graduated as a Master of Public Health from Imperial College London. His previous roles include a Medical Expert (Safety Physician) position at Novartis from 2002 to 2009, Director Pharmacovigilance and EU-QPPV at Medigene from 2009 to 2013, and various positions at Bavarian Nordic from 2013 to 2024, including Director Pharmacovigilance, EU/UK-QPPV, VP Clinical Strategy Infectious Diseases and Global Principal Safety Physician. In those roles, he supported the FDA licensure of a poxvirus vaccine and the clinical development of RSV and COVID-19 vaccine candidates from Phase 1 into Phase 3. In the recent years, he was regularly invited as a guest speaker on CDC and WHO poxvirus related panels and advisory committees. He has been involved in clinical research on mpox and COVID-19 from a vaccine manufacturer’s perspective. In November 2024, he joined BioNTech SE as Safety Strategy Lead, supporting the medical safety perspective of clinical development in oncology and infectious disease candidate products, including vaccines and antibodies.

Dr. rer. nat. Sven Zielke holds the position as Local Safety Officer Austria within Patient Safety Central Europe Group at UCB Pharma GmbH. With over 10 years of experience in different positions in pharmacovigilance he was able to gain knowledge in both local and global PV systems in small and medium-sized companies as well as global corporations. In his respective positions, he was able to contribute to setting up new PV systems or enhancing existing systems and successfully lead them through several audits and inspections. In addition, as a certified QM manager with more than 2 years of professional experience, he has the relevant knowledge to maintain regulatory compliance and inspection readiness of PV systems. Dr. Zielke holds a Doctoral degree in Biology from the Ruhr-University Bochum and additional certified knowledge as Quality Manager, Project Manager and Data Protection Officer.