Industries: Pharma / Biotech

Filing Variations in the European Union™

Course Director: Adriaan Fruijtier, M.Sc.

Course Description - Course runs 9:00 to 5:00 both days

The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.

The course will also provide the attendee with a thorough knowledge of the following topics:

  • Overview of the different types of variations and the different procedures for a Marketing Authorisation in the EU
  • The different types of variations (Type IA, Type IB, Type II)
  • Variations involving product information
  • How to deal with unclassified variations
  • Line extensions
  • Work-sharing

Who Should Attend

This course is specifically designed for personnel in regulatory affairs of pharmaceutical and biotech companies who need to acquire basic knowledge or need to update their knowledge regarding filing variations.

This course will provide you with a comprehensive overview of filing variations, as well as addressing new regulations governing variations to national marketing authorisations and work-sharing which went into effect on 4th August, 2013.

Course Agenda

First Day

Introductions & Agenda Review

Overview of the different types of variations and the different procedures for a Marketing Authorisation in the EU

  • Four different authorization procedures
  • Different kinds of variations
  • Commission Regulation 712/2012

Variations Type IA and Type IAIN

  • Grouping
  • Submission
  • Review

Variations Type IB

  • Grouping
  • Submission
  • Review

Variations Type II

  • Grouping
  • Submission
  • Review

Variations involving Product Information

  • Role of the SmPC
  • Guidelines
  • Referrals

Recap, Questions and Answers

Second Day

CMD(h) recommendations on unclassified variations

  • Where to find the information
  • Examples

Line extensions

  • Submission
  • Timelines
  • Examples

Work-sharing between the regulatory authorities

  • What is work-sharing?
  • Which variations are suitable for work-sharing?
  • Timelines

Practical Session

  • Common mistakes
  • Classify variations according to the guidelines

Recap, Questions and Answers

  • Variations, line-extensions and other post-marketing procedures

Learning Objectives

Upon completion of this course, each participant will have a comprehensive knowledge and understanding of filing variations and line extensions. Special attention will be paid to variations involving product information and how to correctly classify variations.