CRED SmPC

SmPC, Package Leaflet and Label – EU requirements 15 June 2017, London

Course Chairman: Petrina Pearce, Diamond BioPharm Ltd

08:30

Registration and Coffee

08.45

Welcome from TOPRA

TOPRA

08.50

Welcome from Chairman

Petrina Pearce

Overview of the day

09:00 SmPC: Regulator’s perspective  The role of the SmPC 

Patrick Salmon HPRA

Overview of SmPC legislation/guidelines and template  Current SmPC issues and developments

Paul N McCleverty Johnson & Johnson

10:00

Strategy for the Development of the Optimal SmPC

Definition of an optimal SmPC

 Contributing factors to an optimal SmPC  Key Stakeholders in an optimal SmPC  Common Pitfalls in the development of an optimal SmPC  Influence of the optimal SmPC on the development programme  Competitor analysis

11.00

Coffee

11.15

The Company Core Data Sheet

Melanie Eatough Shire Pharmaceuticals

Origins of the CCDS and its purpose

 Preparation and implementation of the CCDS  Implications of regional differences for the CCDS and global labelling management

12.00

Case Study - SmPCs

ALL

12.15

Panel Discussion

ALL

12:30

Lunch

Julia Coombes MHRA

13.30

Labels and Leaflets: Regulator’s perspective

 Current legislation including recent changes  Label and leaflet requirements, including guidelines  Packaging with patient safety in mind  Good quality patient information & user testing  Future focus for patient information

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