






Out of the program Tuesday, September 30 Biopharmaceuticals - an introduction Starting a Development Project/ TPP Pharmacokinetics for biologicals In Vivo Pharmacology Nonclinical Safety Studies Immunogenicity The Regulatory Environment in EU and US for Advanced Therapy Medicinal Products (ATMP)/Regenerative Medicine Advanced Therapy (RMAT)
Wednesday, October 1 Patent/IP Regulatory Strategies in Biologics Drug Development Manufacturing of Clinical Material for Biopharmaceuticals Biosimilars – Non-Clinical and Clinical Aspects Safety Evaluation in Manufacturing of Biologics Including Viral Clearance Clinical Trials Applications for Clinical Trials Translational Sciences/Biomarkers
Thursday, October 2 Financing Health economics and reimbursement Taking a project from idea to a registered product Partnering with Big Pharma Pharmacovigilance Business Development

