Understanding EU Filing Variations

Coming soon

Leave this field blank

By clicking register, you agree to our Privacy Policy

If you would like training for yourself or a group, complete the form above

Course Overview

 

Filing variations is a major component of regulatory lifecycle management. It is important to optimise your procedures for faster, streamlined and compliant variation submissions. Regulators want to see successful variations strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions and best practice for implementation.

 

This training course will provide you with a complete overview of the EU regulations when filing a variation to marketing authorisation. You examine the various types of variation and learn how to optimise your procedures for streamlined variation submissions. You will also examine grouping and worksharing so you know when to apply it to your variations

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Gain a comprehensive overview of the EU Regulations for filing variations to ensure compliance
  • Develop a filing variation strategy to streamline your processes
  • Examine grouping and work-sharing to understand when they can used
  • Review specific variation cases such as changes to module 3 and new clinical data
  • Understand the variations process through centralised, mutual recognition and decentralised procedures
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

Overview of Regulations 1234/2008 and 712/2012 in Europe

  • Classification in accordance with the legislation
  • Understand the differences between Type lA, Type IB and Type ll variations
  • Clarify foreseen and unforeseen Variations
  • Sharing practical experience with European and national procedures
Module 2

Examining grouping and work-sharing

  • Understanding when grouping is appropriate
  • Clarifying what types of variations may be grouped
  • Guidance on assembling a grouped submission
  • Understanding when work-sharing is appropriate
Module 3 & 4

Submitting a variation

  • Identify and understand strategic considerations
  • Handling active ingredient master files as variations
  • Submission of new clinical data
  • Practical session: Analysing and classifying the different changes
  • Data requirements for type II variations
    • Learn how to identify and support a type II change
    • Practical session: Data requirements for more complex changes
  • Understanding Module 3 and the dossier impact on variations
Module 5

Filing strategy

Understanding the following FDA review options:

  • Creating a global dossier (gold/silver/ bronze versions)
  • Understanding implementation and grace periods
  • Fixed and rolling implementation strategy
  • Practical session: Plan the timelines/project management of a variation submission
Module 6

Variations through national procedures and differences from centralised procedure

  • Understand the procedures
  • Languages and translations
  • Explore the linguistic review process
Module 7

Mutual recognition and decentralised procedures for variations

  • Understand the procedures and responsibilities of the MAH, RMS and CMS
  • Learn how to efficiently plan for and run an MR variation procedure
  • Practical session: A variation to an example MRP authorised product including planning timelines and impact of referrals
Module 8

Examining other procedures

  • Article 5
  • Urgent safety restrictions
  • Understanding when to use extension applications

Advanced compliance

  • Creating your own compliance requirements
  • SUPAC guidance

 

Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

 

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.

 

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements and Optimizing the Life of Your Products. Andrew has delivered multiple courses on lifecycle management, specifically filing variations. He has extensive experience of managing marketing authorisations of a range of products such as biotech, small molecules and more recently advanced therapies (ATMPs), specifically cell therapies.

This course is aimed at professionals who involved in the regulatory lifecycle management of their marketing authorisations. These include: Regulatory Affairs Professionals | CMC Regulatory Professionals | Compliance Personnel | Project Managers in Regulatory Affairs | Dossier Registration Professionals | Documentation Specialists.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

Leave this field blank

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.