PharmaQMtraining.eu
Course Outline
 
   
Type IA Variations
A non-residential one-day course in London
xxxxxxx
in association with
the British Generic Manufacturers Association
TIMETABLE
Registration & refreshments: 09.30h – 10.00h
Course start time: 10.00h
Lunch: 13.15h – 14.00h
Course ends: 16.45h
VENUE
Conference Room, BGMA, The Registry, Royal Mint Court, London EC3N 4QN
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WHO SHOULD ATTEND

This interactive course is particularly intended for Regulatory Staff in the pharmaceutical industry who actually handle Variation Applications, especially Type IA Variations, on a day-to-day basis.  Some managers of these kinds of staff may also be interested.  Delegates from BGMA and non-BGMA companies are welcomed.

COURSE LEADERS

Paul Fleming (Chairman): Technical Director, British Generic Manufacturers Association
Dr Krystyna Fielden: MHRA, Unit Manager, Product Lifecycle Assessment Team (PLAT) 2
Dr Mike Robertson: Lecturer, PharmaQMtraining.eu

CHAIRMAN’S INTRODUCTION AND WELCOME

Paul Fleming

AN OVERVIEW OF CURRENT EU VARIATIONS LEGISLATION

Mike Robertson

EXPERIENCE WITH THE VARIATIONS SYSTEM DURING 2010 AND TO DATE AND PROBLEM AREAS

Paul Fleming

RECENT MHRA EXPERIENCE OF VARIATIONS CLASSIFICATIONS WITH SPECIAL ATTENTION TO TYPE IA VARIATIONS, COMMON DEFICIENCIES IN THEIR PRESENTATION AND HOW THESE SHOULD BE AVOIDED

Krystyna Fielden
LUNCH
Workshop Sessions: 
ADMINISTRATIVE CHANGES
PRINCIPLES OF GROUPING
QUALITY CHANGES
CLINICAL CHANGES
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EXCEPTIONAL VALUE: £495.00 + 20% VAT

High-quality, carefully-structured training, lunch and in-course refreshments, delegates manual to reinforce the learning experience and a certificate of attendance
[6h Continuing Professional Development (CPD)]

MORE ABOUT THE BACKGROUND TO THIS COURSE

A high percentage of Type IA variation applications are rejected as invalid for certain subject groups. Rejection of applications is costly to the industry on the grounds of inefficiency. Potentially worse still, if change implementation has preceded news that your application has been rejected, your company faces the strong likelihood of non-compliance with its serious consequences.

Inadequate or unacceptable applications are a waste of staff resources both for companies and the MHRA.

The objectives of the course are to promote better training of regulatory staff and to improve compliance within BGMA and non-BGMA companies

Book here

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