German Pharmacovigilance Day - Speakers

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.

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 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.

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 veterinarian with extensive experience in pharmacovigilance roles at local, regional, and global levels in various companies, including CROs, generics, and originator companies. She has a strong passion for the Spanish language, Latin music, and beaches, which led her to move to Panama and work as a Drug Safety Lead for the Latin American region.

Throughout her career, Sabine has held multiple pharmacovigilance positions, ranging from standard PV activities to ensuring compliance in patient support and market research programs, digital initiatives, and the local implementation of Risk Management Plans.

Prior to her current role as Head of Patient Safety Switzerland, Sabine served as the responsible person for product information (Informationsbeauftragte) and acted as an agile product owner, overseeing the development of an end-to-end product management flow.

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.

EDUCATION: Study of Chemistry in Bonn (University of Bonn), Master of Drug Regulatory Affairs (University of Bonn) |

PREVIOUS POSITION: Teacher (Chemistry + Physics) in 2011, Drug Safety Junior Manager at UCB Pharma in 2011-2012; Manager Regulatory Affairs at Mucos Pharma in 2012-2014; Stufenplanbeauftrager, Informationsbeauftragter (DE+AT), various positions in Regulatory Affairs and Pharmacovigilance from 2014 to 2021. |

PRESENT POSITION: Head of Global Pharmacovigilance, QPPV, Stufenplanbeauftragter since 2021 |

INTERESTS/ EXPERIENCES: Member of the BPI Working Group for Pharmacovigilance; Guest Speaker at the Hochschule Reutlingen since 2023

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.