Day one / Preapproval Regulatory Affairs
08:30 to 08:45
Introduction
Siobhán Dean & Karina Cassidy BioPharmaChem Ireland
08:50 to 09:50
EU Pharmaceutical Legislation & EU Regulatory Systems (Centralised Procedure, MR & National
Anne Marie Mannion, A.M Consultancy
Registration of APIs (including CEPs)
Dr. Colette Rohan Director of Regulatory Affairs ,McKesson Northstar
11:15 to 11:45
CTD: Drug Substance Small Molecule
Maria McCarra, Regulatory Affairs Scientist, Eli Lilly Ltd.
11:50 to 12:15
CTD: Drug Substance Large Molecule
Brian Corrigan, Executive Director CMC at MSD
12:20 to 13:00
Advanced Therapies Special Consideration
Amy Lindley CMC Biologics Sanofi
13.00-13.30
13:30 to 14:30
CTD: Drug Product
Meg McCarthy, PRSI Ltd
14:35 to 17:00
FAQ All
Day Two / Post Approval Regulatory Affairs
08:30 to 08:45
Introduction
Karina Cassidy BioPharmaChem Ireland
08:50- 09:50
Common Deficiencies in CMC part of Application
Mirza Catibusic, The HPRA
09:55 – 10:55
EU Variations and Industry Experience with Variations
Helen Crowley, Regulatory & PPV Manager,
Eamonn McGowran, Strategic Regulatory and Quality Advisor, Kora Healthcare
11:15 to 12:45
Common Issues with Variations and Batch Specific Requests
Mirza Catibusic, The HPRA
13.00-13.30
13:30 to 14:00
US Pharmaceutical Legislation & Submissions
Meg McCarthy, PRSI Ltd
14:05 to 14:35
US Post Approval Changes
Lisa Cleary, CMC Biologics Sanofi
14:40 to 15:30
FAQ
All