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

09:55 to 10:55

Registration of APIs (including CEPs)
Dr. Colette Rohan Director of Regulatory Affairs ,McKesson Northstar

 

11:00 to 11:15

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

11.00-11.15

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 

Start Date September 15, 2022
Time 08.30
Duration Two days
Delegate Price Member
€500 (+VAT),
Non-Member
€750 (+VAT)
Location Online
Type Virtual events
Contact siobhan.dean@ibec.ie