German Pharmacovigilance Day - Relatori

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 Head of Solution Design at Qinecsa. 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.

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.

Henry Barton is a physician and pharmacovigilance expert with a expertise in surgery, anesthesiology and drug safety. He has over a decade of hands-on experience in various clinical settings, including intensive care and emergency medicine.

As a Global Safety Lead at Grünenthal, Henry oversees the pharmacovigilance activities around several post-marketing products, such as esomeprazole and zolmitriptan. He is also responsible for designing and implementing risk management strategies, including innovative software solutions, which simplify workflows and enhances the efficiency of drug safety monitoring and risk mitigation. He is also deeply involved in the creation and submission of risk management plans, with a special focus on the anonymization of privacy-sensitive data and the protection of confidential corporate information. Furthermore, Henry has a profound interest in benefit-risk methodology and its use to navigate complex assessments that confirm the positive benefit-risk balance of medicinal products.

Dr Martin Huber has been the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) from 2012 to 2026 and had been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including various PSUR Single Assessments at PRAC and also contributed to the work of several working groups at the European level. From 2018 to 2024 he served as vice-chair of PRAC.
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 joining the public sector in 2010. Since 2013 he has been unit head in charge for various pharmacovigilance tasks. In 2024, he took over responsibility for pharmacovigilance as a whole.

Zurab Koberidze has over 25 years of experience in clinical trials, health care management, medical safety and pharmacovigilance. Having gained his degrees from State Medical University in Tajikistan and University of California at Berkeley in US and before joining FGK, Dr. Koberidze conducted clinical studies and worked in hospital settings afterwards spending several years working for a charity in developing countries. His medical safety and pharmacovigilance expertise for the last 12 years at FGK covers among others design and management of study specific and IMP-wide global safety sentinel systems that can transition to post-marketing pharmacovigilance activities, which he oversees for many clients as a EU Qualified Person for Pharmacovigilance.

Sabine Poltermann is a senior pharmaceutical leader and executive coach with extensive international experience in highly regulated, complex environments. She believes that leadership is not a role – it is a conscious choice.

Having worked across local, regional, and global organizations, Sabine combines strategic clarity with deep self-awareness in her leadership and coaching approach. She supports leaders in moving beyond managing complexity to leading with confidence, trust, and purpose by strengthening self-leadership, emotional intelligence, situational leadership, and coaching as a powerful leadership mindset.

Known for her clear, reflective, and pragmatic style, Sabine inspires leaders to step out of autopilot and lead with authenticity – turning vision into action and leadership into a lived experience.

Geraldine Prager studied biology at the University of Bayreuth and then worked at the department of psychoneuroimmunology at the University of Essen. In 2013, she began her professional career as Junior Drug Safety Manager at UCB Pharma GmbH in Monheim am Rhein. From this date to 2023 she held various positions of increasing responsibility – since 2019 Graduated Plan Officer and most recently also as Local Safety Officer Germany. Since mid 2022 Geraldine Prager also supports the Qualified Person for Pharmacovigilance as additional deputy and could expand her knowledge from local and regional to global level. Throughout her carrier she managed different topics from case processing, patient support programs, aggregate reports, implementation of risk minimization measures, quality management system, audit and inspection up to vendor management.

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.

After working for more than 15 years helping innovators from around the world launching communication, medical device and software products in the German-speaking markets, also providing training and support for those products, Christian fully moved into the GxP domain 20 years ago and helps large and small companies getting their regulated processes and systems right. His main topics are Quality, Pharmacovigilance, and Learning.
A biochemist by formal education, Christian was responsible for the validation of strictly regulated systems and led teams bridging the gap between business and IT. At a major software vendor in the Pharmacovigilance domain he worked with customers on successfully matching processes and systems and guided teams on creating compliant tools, leveraging agile and lean practices in a strictly regulated software manufacturing environment. For the past years he has been helping clients as an independent consultant, project manager, and trainer in projects to stay on top of rapidly changing technology while improving quality, compliance and value. With the evolution of machine learning, language models large and small, AI and GenAI, Christian works with clients to identify how these new tools can be added to the industry`s toolbox for use in regulated environments.

Lionel Van Holle is an experienced pharmacoepidemiologist with a demonstrated history of bringing innovation and new ways of working. He faced two pandemics (H1N1, Covid) and several mass vaccinations when working for GSK Vaccines where he developed the in house Signal Mining and Management system. He subsequently created OpenSourcePV in 2019 with the aim of building of suite of pharmacovigilance tools using open source technology to make safety transparent and accessible.