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Day 1

Regulatory Strategy for Navigating Pandemic Disruption
S.M. Mudda, Managing Director, Misom Labs Limited, Malta (EU), Chairman Regulatory Affairs Committee, IDMA
Pharmaceutical Product Lifecycle Management
Emma Ramnarine, Executive Director, External Development Collaborations, Genentech/Roche Co-Lead Industry 1VQ for PACs
cGMP Inspections Amid COVID-19 Pandemic
Marie Morin, Former FDA Drug Specialist and now Principal Auditor for MFM GMP Consulting
The Art of Filing (Abbreviated) New Drug Applications [(A)NDAs], Biologic License Applications (BLAs) and Post-Approval Changes to the US FDA
María José (Pepa) López Barragán, PhD
Growing Momentum of Biosimilars and US FDA Regulations
Kurt Brorson, Ph.D R & A, Parexel International
Ivo Bucaresky, Former Director, ANVISA
Evolving FDA Quality Assessment for Small Molecule Human Drug Products
Geoffrey Wu, Ph.D. Commander, US Public Health Service Deputy Director, Office of Lifecycle Drug Products OPQ|CDER |US FDA

Day 2

K Regulatory Environment: Now and into the Future
Graham Carroll, GMDP Operations Manager and Senior Inspector
Biosimilar medicines Policy Competition, Education and Continuous Adaption
Julie Maréchal Jamil, Director Biosimilars Policy & Science
Risk Assessment Best Practice - Development of a Cross Pharma Work-flow for DP Nitrosamine Risk Assessment
Dr. Mike Urquhart, Scientific Director, GSK Pharmaceuticals, UK
Major GMP developments and their impact for pharmaceutical industry
Dr. James Drinkwater, Head of GMP Compliance & Aseptic Process Integration F Ziel GbmH
Drug Device Combinations – Evolving Regulatory Landscape
Dr. Praveen Kumar L, Director – Regulatory Affairs, Head – India, Medical Devices, Regulatory Assurance; & Data Systems, Cipla Ltd.

Day 3

Indian Pharma Industry Changing Dynamics of Regulatory Affairs
Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance
Continuous Manufacturing The Regulatory Landscape
Dr. Sarah Pope Miksinski, Senior Director-Regulatory CMC/CMO, AstraZeneca
Regulatory Innovation in Canada
Samar Darwish, Director-Drug Regulatory Affairs, Boehringer Ingelheim, Canada

Day 4

NitrosamineTesting: The Regulatory Aspects
Dr. Houri Simonian Health Science - Director, Analytical Operations, SGS Lifesciences

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