European Regulatory Affairs Summer School
Fitzwilliam College
Fitzwilliam College
Cambridge, UK
European Regulatory Affairs Summer School
Informa Ltd 

Schedule of Presentations:

Tuesday, July 28, 2009
08:15:00 Registration
08:45:00 Chairpersons welcome remarks and introduction to the Summer School 2009
09:00:00 Introduction to the regulatory framework Susan Genseberger
09:45:00 Seeking regulatory scientific advice in Europe Richard Peck
10:30:00 Morning coffee
11:00:00 Successful compilation of the CTD Paul Williams,
11:45:00 Practical session: building the CTD Geoff Williams
12:45:00 Lunch
14:00:00 Marketing authorisations: Centralised procedure, CP Sandrine Courthéoux
14:45:00 Marketing authorisations: Mutual Recognition Procedure, MRP and Decentralised Procedure, DCP Ivanka Atanasova
15:30:00 Chairpersons closing remarks and end of day 1
16:00:00 Punting on the River Cam
Wednesday, July 29, 2009
08:45:00 Welcoming remarks by the Chairperson
09:00:00 Introduction to the eCTD and basic principles Lillian Reilly
09:45:00 Regulatory operations, lifecycle management of the eCTD and future developments Dan Verrall
10:30:00 Morning coffee
11:00:00 Understanding the recent developments in filing variations Marcello Milano
11:45:00 Ensuring complete compilation of CMC data Janice Kirby-Smith
12:30:00 Lunch
13:45:00 Comprehension of processes surrounding orphan drugs Petra Heyen
14:30:00 Building a comprehensive strategy for packaging and labelling Luc Van Driessche
15:15:00 Afternoon refreshments
15:45:00 Readability Testing for Patient Information - how to meet the regulators requirements Theo Raynor
16:30:00 Practical session: patient information Theo Raynor
17:30:00 Chairman’s closing remarks and end of day 2
17:35:00 Announcements
Thursday, July 30, 2009
08:30:00 Welcoming remarks by the Chairperson Raj K. Bains
08:45:00 Ensure a successful Clinical Trial Application (CTAs) Gillian Holmes
09:30:00 Practical session: CTA compilation Gillian Holmes
10:30:00 Morning coffee
11:00:00 Paediatric Regulation Neil Edwards
11:45:00 The paediatric investigation plan Adnan Mahmood
12:30:00 Lunch
13:45:00 Pharmacovigilance: A primer for regulatory affairs personnel Raj K. Bains
14:30:00 Ensure regulatory success for Inspections Lesley Winch
15:15:00 Afternoon refreshments
15:45:00 Optimising risk management planning Brian Edwards
16:30:00 Reporting requirements throughout the product lifecycle Graeme Ladds
17:15:00 Chairperson’s closing remarks and end of the Summer School 2009
3D Tissue Models
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