PharmaQMtraining.eu
Course Outline
 
   

Printable version

A Short Course on Regulatory Affairs with emphasis on
Building your Understanding of Variations
to Marketing Authorisations
TRAINING WITH A BALANCED COMBINATION OF LECTURES
AND PRACTICAL HANDS-ON CASEWORK
The Course topics include
(this is not necessarily the running order)

INTRODUCTION AND WELCOME

OVERVIEW OF EU VARIATIONS LEGISLATION

  • Historical perspective
  • Current variation legislation
  • New variation legislation (effective from 1 January 2010)
  • Type I versus Type II variations
  • The Global Marketing Authorisation
  • Extension applications
  • Urgent safety restrictions

VARIATIONS PROCEDURES IN THE EU – CURRENT AND PROPOSED

  • Procedures, timelines, transparency, fees
  • National Procedures
  • Centralised Procedure
  • Mutual Recognition and Decentralised Procedures (MRP and DCP)
  • New or improved concepts: annual reporting, worksharing, grouping of variations

ANALYSIS OF THE CURRENT AND NEW CLASSIFICATION GUIDELINES

  • Administrative changes
  • Quality changes
    • Active substance
    • Finished product
  • CEP/TSE/monographs
  • PMF/VAMF
  • Medical devices
  • Safety, Efficacy, Pharmacovigilance

TYPE I/II VARIATIONS:  UNDERSTANDING CHANGES IN THE SOURCING OF SYNTHETIC EXISTING DRUG SUBSTANCES

  • Regulatory commitments
  • Active Substance Master Files
  • Certificates of Suitability
  • Stability

TYPE I/II VARIATIONS:  UNDERSTANDING CHANGES IN THE MANUFACTURING PROCESSES FOR DRUG PRODUCTS

  • Formulation changes, bioavailability / bioequivalence
  • Manufacturing process
  • Manufacturing site
  • Packaging
  • Stability and shelf life
INTERSPERSED WITH THE LECTURES WILL BE A
SERIES OF GROUP INTERACTIVE MINI-WORKSHOPS
#1 CATEGORISING VARIATIONS – CURRENT CLASSIFICATIONS AS APPLIED TO NATIONAL APPLICATIONS
#2 ASSESSING THE LIKELY DATA / DOCUMENTATION REQUIREMENTS FOR SOME TYPE II VARIATIONS ... AND EXPLORING PARALLEL AND CONSEQUENTIAL VARIATIONS
#3 CATEGORISING VARIATIONS USING THE NEW CLASSIFICATIONS
#4 METHOD OF MANUFACTURE: CASE WORK ON CHANGE IN MATERIALS AND TRANSFER OF TECHNOLOGY Previous page

EXCEPTIONAL VALUE: £995.00 + 17.5% VAT
Your delegate package includes training from experts over two days, training materials, certificate of attendance, daytime food and drinks, a conference dinner and one night’s accommodation*
* extra night(s) bookable if required, subject to availability


MORE ABOUT THE BACKGROUND TO THIS COURSE
AND WHO SHOULD ATTEND

This Variations Course will be a comprehensive course that builds from first principles but quickly extends to include considerable detail about how different types of change can be made to Marketing Authorisations (MAs) now and in accordance with the new system scheduled to be effective incrementally from 1 January 2010.

This course is suitable for people needing to understand variations for the first time .... as well as for those who need a refresher course .... or to have an awareness of how the work they already do on Variations may soon have to change (or not!) because of the new legislation and supporting guidelines.

The trainers will be Dr Hugh Delargy and Dr Mike Robertson who have many years of experience as Assessors with the UK Licensing Authority in which time they have assessed tens of thousands of Variation Applications.

After attending the course, you should expect to be able to handle Variation applications more confidently, accurately and cost effectively now and in accordance with the new procedures.  Fewer rejections of submitted Variation Applications should repay the training costs many times over.

Please sign up for future announcements

Previous page