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Thursday, September 26
9:10–10:30 Morning session 1
Biosimilar New Guideline for In Vivo Waivers
René Anour (AGES)
Product-Specific Bioequivalence Guidance and Legal Basis for Complex Molecules
Parvinder Punia (Pharmexon)
11:00–12:30 Morning session 2
Paulo Paixão (University of Lisbon)
Navigating the Science: Exploring the Development and Validation of Dosing Guidance
Tools
Martin Wolfsegger (TAKEDA)
13:45–15:45 Afternoon session 1
Orally Inhaled Products – Guideline Update
Carolien Versantvoort (CBG-MEB)
Requirements from Draft Nasal and Inhaled Products Example of Dissolution for Inhaled
Products
Jean-Michel Cardot (SAS BORVO)
OIP – Where We Are and Where We Go
Vít Perlík (Pharmacology, Faculty of Medicine, CU, CADORE)
16:15–17:00 Afternoon session 2
Development of Lenacapavir (Sunlenca), the First-in-Class Long-Acting HIV Capsid Inhibitor
Administered Twice-a-Year
Raju Subramanian (Gilead)
Friday, September 27
9:00–10:30 Morning session 1
ICH M15 Model-Informed Drug Development General Principles Guideline
Pavel Farkaš (TEVA / PLIVA)
Susana Almeida (International Generic and Biosimilar Medicines Association)
11:00–12:30 Morning session 2
OTC Status for Products – National Specificities
Paolo Biffignandi (VI.REL Pharma)
Loice Kikwai (LCK Pharmaceutical Consulting)