The Quality of Medicines - Future Evolution
9th April 2014

Regulatory Delegates:

The Regulatory agenda can be found in the Delegate Area, under 'Information & Downloads'. Login details for the Delegate Area are provided automatically by email after registration.

The Industry agenda for the day is outlined below:

09:00-09:30

Registration and refreshments

09:30-09:40

Welcome & Introduction

Sir Gordon Duff, Chairman, MHRA

09:40-10:05

The British Pharmacopoeia - Celebrating 150 years

Dr. Samantha Atkinson, Secretary and Scientific Director, BP & MHRA

10:05-10:30

The European Pharmacopoeia: Harmonisation and Collaboration throughout Europe – a success story

Dr. Susanne Keitel, Director, EDQM

10:30-11:00

Refreshment break

11:00-11:15

Independent QC labs, how they differ from labs located at a manufacturing site

Lesley Graham, Senior Inspector, MHRA

11:15-12:00

Challenges associated with contract QC

Dr Paul Moran, Broughton Laboratories

Christine Gray, Senior Inspector, MHRA

12:00-12:45

Out of specification investigations

Lesley Graham, Senior Inspector, MHRA

12:45-13:45

Lunch

13:45-14:15

Data fraud

David Churchward, Expert Inspector, MHRA

14:15-15:15

Crisis management

Christine Gray, Senior Inspector, MHRA

Adam Burgess, Manager, Defective Medicines Reporting Centre (DMRC), MHRA

15:15-15:30

Q&A – Panel session

15:30-16:00

Refreshment break

16:00-16:20

Changing world - the move toward biologicals

Stephen Inglis, Director, NIBSC

16:20-16:40

Harmonisation Activities

Dr. Sabine Kopp, Group Lead, WHO

16:40-16:45

Final remarks and close

Gerald Heddell, Director of Inspection, Enforcement and Standards Division, MHRA

* Timings and content will be subject to change.