Dr. Peter Bachmann is a senior regulatory scientist with over 25 years of leadership at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and deep expertise in EU and global regulatory harmonization. He served as Chair of CMDh, Member of the EMA Scientific Coordination Board, EU Network Data Board, and HMA, representing the EU in ICH and as Chair of IPRP. Currently a Board Member of DGRA, he holds a Ph.D. in Pharmaceutical Biology from the University of Würzburg and completed postdoctoral research in Japan and the UK. He lectures at the Universities of Bonn, Basel, and Copenhagen, and has received TOPRA Lifetime Membership, MEGRA Honorable Membership, DIA Fellowship, and the DIA Outstanding Contribution to Health Award

Dr. Anna Silke Hammerbacher (M.D.R.A.) is Vice President of Regulatory Strategy at SSI Strategy with 15+ years of global experience in drug development and regulatory affairs. She has led the regulatory strategy for several major blockbuster products, focusing on expedited approvals and market access. Her expertise spans oncology, immuno-oncology, and rare diseases, including global MAA/BLA/NDA submissions and EMA/FDA interactions. Holding a Ph.D. in Molecular Microbiology and a Master of Drug Regulatory Affairs, she is known for innovative fast-to-patient strategies, leadership across functions, and multiple industry awards for excellence and innovation.