Abridged applications symposium
9 June 2015, 1 VS Conference Centre, London

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9.00 - 9.30

Registration and refreshments

9.30 - 9.35

Welcome and opening remarks

Dr Siu Ping Lam, Director of Licensing Division

9.35 - 9.50

Introduction

Sue Harris, Unit Manager, Licensing Division

9.50 - 10.15

UK as RMS - what to expect (MRP/DCP)

- Procedure Coordinators
- RMS role during validation
- when we can start TT; use of pre-submission check list
- contacts during clock off and circulating dossier at D106

Lorraine Geear, MRDC/RIS Business manager, Licensing Division

10.15 - 11.00

Compiling the perfect dossier - how to avoid the pitfalls


Legal basis and Reference Product

Dr CC Lee, Senior Pharmaceutical Assessor, Licensing Division

How to avoid frequent issues: hints and tips

Bhumika Yadav, Senior Scientific, Classifier, Licensing Division
Aidan Hardy, Delivery Manager, Information Processing Unit, Licensing Division
11.00 - 11.20

Refreshment break and networking

11.20 - 11.45

National scientific advice and regulatory advice (DW)


How the MHRA can help - scientific and regulatory advice meetings

Dr David Wright, Expert Statistical Assessor and Deputy Unit Manager, Licensing Division
11.45 - 12.30

Submitting the perfect dossier

- eCTD
- routes of submission
- hints and tips on avoiding common issues

Rachel Hyde, Delivery Manager, Information Processing Unit, Licensing Division

12.30 - 13.25

Lunch

13.25 - 14.10

Generics - what makes them different?


Bioequivalence

Dr Jon Sisson, Senior Medical Assessor, Licensing Division

Quality aspects

Dr Abigail Moran, Senior Pharmaceutical Assessor, Licensing Division
14.10 - 14.30

ASMF - initiatives in Europe and common issues during DCP

Dr Paul Marshall, Senior Pharmaceutical Assessor & Chair of CMDh ASMF WP, Licensing Division

14.30 - 14.50

Refreshment break and networking

14.50 - 15.20

Clock off - preparing your draft responses and the National phase

Dr Abigail Moran, Senior Pharmaceutical Assessor, Licensing Division

15.20 - 16.20

Meet the experts

16.30

Close

Sue Harris, Unit Manager, Licensing Division

* Each presentation slot will include 5 minute question and answer session.