Karoline Bechtold-Peters, Novartis Pharma AG, Helen Newton MSD, Merck Sharp & Dohme, Fionnuala O'Driscoll, Eli Lilly Kinsale Limited
Welcome & Introductions, EFPIA Updates - Markus Goese, F Hoffman-La Roche Ltd
Click Here to View Speaker PresentationEstablishing Platform Technology Master Files for human medicinal products in the EU/EEA - Mihai Bilanin, GSK
Click Here to View Speaker PresentationImmunogenicity or Not of Biologics in the Subcutaneous Space - Sathy Balu-Iyer, SUNY
Modelling of Subcutaneous Injection & Bioavailability to Bridge IV/SubQ - Joel Gresham and Max Dixon, Crux Product Design
SubQ Bioavailability Considerations - Manuel Sanchez-Felix, Novartis
Click Here to View Speaker PresentationCMC Aspects When Switching from Intravenous to Subcutaneous Formulations - Christian Mayer, AGES MEA
Click Here to View Speaker PresentationRichard Keane, Biogen Idec Limited, Thomas Stangler, Novartis Pharma AG, Diane WilkinsonAstraZeneca
EMA Perspectives on ICH M4Q(R2) and Digital Regulatory Assessment - Klara Tiitso, EMA
Click Here to View Speaker PresentationFDA Perspective on Opportunities for Modernization of Regulatory Submissions - Ingrid Markovic, CBER, FDA
Click Here to View Speaker PresentationM4Q IHC Current Status and Vision from Industry - Sarah Pope Mikinski, AstraZeneca
Click Here to View Speaker PresentationThe Power of Data Exchange, CMC Interoperability and Cloud-Based System - Michael Abernathy, Amgen, Inc, Accumulus Synergy
Click Here to View Speaker PresentationMihaela Buda, EDQM-Council of Europe, Joan Malmstrøm, Novo Nordisk A/S, Heli Suila, Finnish Medicines Agency (FIMEA)
Regulatory considerations for the application of Multi Attribute Methods by Mass Spectrometry for QC release and stability testing of Biopharmaceuticals - Annick Gervais, UCB Braine L'Alleud
Click Here to View Speaker PresentationA roadmap to get host cells proteins analysis by mass spectrometry in a GMP environment - Cyrille Chéry, UCB Braine-L'Alleud
Click Here to View Speaker PresentationMichael Abernathy, Amgen Inc., Seán Barry, HPRA-Health Products Regulatory Authority, Lionel Randon, Ares Trading S.A., An affiliate of Merck Serono S.A.
Regulatory Considerations for Modeling as a Tool for Process Understanding and Control - Matthew Popkin, GSK plc
Click Here to View Speaker PresentationEnhanced Process Characterization study withMonte-Carlo Simulation. From a static to a dynamic understanding of a manufacturing process - Hervé Broly, Merck-Serono
Click Here to View Speaker PresentationUsing Stability Prior Knowledge From ‘Like-molecules’ to Determine Shelf-life - Andrew Lennard, Amgen Ltd
Click Here to View Speaker PresentationA personal perspective on the use of models in Module 3 - Dr. Nick Lee, HPRA
Click Here to View Speaker PresentationSandra Auguste-Bowler, Novo Nordisk A/S, Seán Barry, HPRA-Health Products Regulatory Authority, Teresa Pepper, BioMarin U.K. Ltd.
How to Leverage Pharmaceutical Development and Manufacturing Data for Marketing Authorisations - EMA's Perspective - Veronika Jekerle, EMA
Click Here to View Speaker PresentationSetting acceptance criteria for release specification based on limited batch data - David Kirke, BioMarin UK Ltd.
Click Here to View Speaker PresentationIndustry Proposal For The Use Of QBD And ICH Q12 Principles To Enable Second Sourcing Of Raw Materials - Dr. Kavita Aiyer,
Seagen Inc
Efficiency Toolbox - CMC Lessons Learned from COVID - Dr Mark A Pellett, AstraZeneca
Click Here to View Speaker PresentationKatrin Buss, BfArM, Federal Institute for Drugs and Medical Devices, Janine Jamieson, IPQ Publications, Tara Sanderson, UCB Pharma Ltd.
Support to Innovation by EMA –Facilitating Translation of Technology into Medicinal Products - Dr.Robert N. Bream, EMA
Click Here to View Speaker PresentationAgile manufacturing - Transfer and Scale-up of Biologics Aseptic Manufacturing Processes through Control Site Concept - Karoline Bechtold-Peters, Novartis Pharma AG
Click Here to View Speaker PresentationContinuous Manufacturing in Biologics Adoption and Regulatory Engagement - Dr. Ana Silvia Nita, Merck Sharp and Dohme
Platform protocol templates: An innovative upcoming tool for comparability assessment and process validation - Olga Rovira, CEPI
