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 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.

Monika Borchert, MD, PhD, has over 30 years’ experience in the pharmaceutical industry in various areas such as clinical development, regulatory affairs, portfolio stewardship, device vigilance and pharmacovigilance in mid-sized and large pharmaceutical companies. She is currently employed by Novartis. Her main expertise is in pharmacovigilance with over twenty years’ experience as safety physician with responsibilities for expedited reporting, defining the safety strategy and authoring of regulatory safety documents for individual products, as coordinator of safety topics for a senior development safety governance board, as Deputy QPPV with shared responsibility for the maintenance of the PV system and as Medical Director of the QPPV Office, a role she has held for the past six years. Her key focus in this role is on oversight of emerging safety issues and benefit-risk profiles of the product portfolio, including signal detection and management, aggregate reporting and risk management.

Stefan Brüning is Co-Founder and Consulting Practice Lead at VIGINEXT. With 14 years of experience across the CRO, pharmaceutical, and biotech sectors, Stefan specializes in the strategic development of Pharmacovigilance (PV) Ecosystems and the integration of Process Automation and AI solutions.
His expertise lies in bridging the gap between GVP compliance and practical technological applications to enhance operational efficiency. Stefan has extensive experience leading complex technical transitions and organizational change processes, including the implementation and optimization of global safety databases and cloud-based PV platforms.
Stefan holds a Master of Business Administration (MBA) with a focus on Change Management, Leadership, and Strategy Analysis , as well as a Master of Science (Dipl.-Biol.) in Molecular Biology. He is a certified Project Management Professional (PMP®) and Certified Professional in Managing AI (PMI-CPMAI)

Bijal Dhanani is a pharmacist with over 18 years of experience across clinical practice and pharmaceutical drug safety. Her career began in community pharmacy, hospital, and NHS commissioning settings in the UK before a mid-career relocation to Germany and a move into pharmacovigilance, where she has built her career at senior level in her third language.

She is currently a Senior Product Safety Officer at Merz Aesthetics in Frankfurt, where she leads signal surveillance and human-in-the-loop case assessment alongside periodic safety reporting, post-market surveillance, and clinical development safety activities.

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.

Denny Lorenz has over 20 years of experience in pharmacovigilance, with deep expertise in global operations, automation, and artificial intelligence.

He spent many years at a large pharma company in Berlin, where he led global teams and large-scale programs in adverse event case processing and safety surveillance. He was responsible for the global PV Systems before serving as Therapeutic Area Head for case processing in Specialty Medicine and Consumer Health, including three years based in Brazil. His work includes designing end-to-end PV processes, complex sourcing models, and strategic technology implementations.

He holds a background in business administration, informatics, and consumer health care.

Denny is a member of CIOMS Working Group XIV. His current focus is the responsible adoption of AI in PV, balancing innovation with regulatory compliance, quality, and trust.

ANNA-SHARI MELIN is a leader of the Global Life Sciences practice in Munich. Her practice combines EU and German regulatory, compliance, environmental, social and governance (ESG) as well as private equity/M&A experience. Her clients include pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer goods companies.

Anna has vast experience in product lifecycle multijurisdictional regulatory matters. Her clients value her analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs, pharmacovigilance, supply chain management including shortages prevention, product recalls, marketing and advertising, interactions with healthcare professionals and related compliance, as well as due diligence for life sciences transactions. Anna has advised several international clients, including U.S. food supplement clients, on strategic market entry in Germany and the EU.

Anna has represented clients in matters before the European Commission, the European Medicines Agency, the European Court of Justice and the German Federal Court of Justice (Bundesgerichtshof), for example in pay-for-delay appeals.

Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics. She also co-leads Sidley’s Life Sciences ESG Roundtable, a discussion forum for in-house counsel to exchange in relation to the EU’s evolving sustainability/ESG legislative framework.

Prior to joining Sidley, Anna was an associate at international law firms in Brussels.

Nadia Mudie, PhD, MSc PV, has over 10 years experience in academic institutes and in the pharmaceutical industry in the UK in various areas such as cancer research, epidemiology, clinical trials and medical statistics. 

Nadia eventually traded the UK for the mountains of Switzerland to join the team at Roche. Her main expertise is in pharmacovigilance with 13 years experience in clinical safety and pharmacovigilance global process owner.

Dr. Ilona Schonn is a pharmacist with 20 years of experience in the pharmaceutical industry, especially in pharmacovigilance. She spent many years at a German headquarter, with a focus on partnership management and PV systems. In 2017, Ilona founded the company elbPV, fully specialised in pharmacovigilance services. With her team, they support clients of all sizes, from small companies to international corporations, with any kind of pharmacovigilance services, including provision of QPPV, setup and maintenance of PV systems, auditing as well as daily business support. With the focus on their clients Ilona has gained valuable experience in creating efficient PV processes.

In addition, she is working as a speaker on the topics of GVP audits and PV agreements.

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.