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