ExpertFORUM Global Regulatory Affairs

Granzer Regulatory Consulting & Services GmbH, Munich, GERMANY

Dr Granzer is the CEO of Granzer Regulatory
Consulting & Services GmbH, Munich, and thus acts
as an independent consultant for drug development
and drug approval.

IQVIA Commercial GmbH & Co. OHG, Neu-Isenburg, Germany

Evidence Strategy Lead
Real-World Evidence Solutions

Arcana Life Science Consulting, S.L.

Independant Consultant in Regulatory Information Management;
Remco has recently taken on the role of independent consultant as the founder and owner of Arcana, bringing over 20 years of deep expertise in Life Sciences and Regulatory Affairs. With more than a decade of consultancy experience, he has led initiatives in Regulatory Information Management (RIM) and electronic submissions, earning recognition as a trusted expert in the field. His subject matter expertise encompasses dossier and data management, including eCTD, xEVMPD, and ISO IDMP, positioning him as a strategic partner for regulatory transformation and compliance.
Remco's influence extends into numerous organizations where he actively participates and holds leadership roles. These include Medicines for Europe, where he serves as the Chair of the Regulatory Data & Digital Systems (ReDDS) group; he is President of the IRISS Forum: a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals; and Remco is a member of the Regulatory Optimization Group (ROG) where EMA, HMA and industry come together.
Remco strongly believes that innovation in the Life Sciences sector does not solely rely on waiting for the next significant breakthrough or a fortunate turn of events. His vision is built on the conviction that innovation is best fostered by cultivating a proactive attitude. This involves taking strategic, incremental steps that evolve into data-driven leaps, propelling us towards unprecedented discoveries and superior innovation. This proactive, calculated approach not only expedites our progress but also paves the way for ground-breaking advancements.

Bayer AG, Wuppertal, Germany

Global Regulatory Strategist

Bayer AG, Wuppertal, Germany

Global Regulatory Strategist

UCB BIOSCIENCES GmbH, Monheim, GERMANY

Policy and Intelligence Lead,
Regulatory Community Excellence

Independent Regulatory Science Expert

Dr. Stöckert has extensive experience in global pharmaceutical development, collaborating closely with the FDA and EMA.

LORENZ International LLC, Philadelphia USA

Senior Adviser Submission Strategy, LORENZ Life Sciences
Mark has over 40 years of experience in information management including over 30 years with the United States Food and Drug Administration (FDA). His FDA responsibilities included software development and project management, Director of Applications Development & Services in the Center for Drug Evaluation and Research (CDER), Prescription Drug User Fee Act (PDUFA) IT Program Director, and Division Director of Data Management Services & Solutions managing CDER's electronic submission program. From 2014 to 2025 Mark worked for the Center for Biologics Evaluation and Research (CBER) data standards group. His responsibilities included supporting the development and implementation of electronic standards (e.g., eCTD), developing electronic submissions guidance, and ICH M8 (eCTD) Rapporteur. In May 2025 Mark joined LORENZ Life Sciences concentrating on supporting LORENZ's regulatory agency clients.