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Regulatory Lifecycle Management in The EU (Filing Variations)
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Regulatory Lifecycle Management in The EU (Filing Variations)

13 May 2025 | Short Online Course

Original price was: £595.00.Current price is: £476.00.

(1 customer review)

1-day live online training | Develop effective regulatory strategies for filing variations in the EU – Click Here to Download the Agenda

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Enrol before 18 April to save 20% (May Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Filing variations are 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 of strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions and best practices 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 work-sharing so you know when to apply it to your variations.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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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
  • Review the impact of the latest proposed amendments to the European Commission guidelines on variations categories and procedures

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

13 May 2025

1-Day Live Online Training
Register at the top of the page.

7 October 2025

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

13 May 2025

7 October 2025

 

180 mins | 9:30 AM UK

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 1234/2008, Commission Regulation 712/2012 and others

Variations Type IA and Type IAIN

  • Grouping
  • Submission
  • Review

Variations Type IB

  • Grouping
  • Submission
  • Review

Variations Type II

  • Grouping
  • Submission
  • Review
Session 2

13 May 2025

7 October 2025

 

180 mins | 1:30 PM UK

Variations involving Product Information

  • Role of the SmPC
  • Guidelines
  • Referrals

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

Other procedures

  • PSURs
  • Renewals and annual reassessments

Practical Session

  • Common mistakes
  • Classify variations according to the guidelines

Examine the latest proposed amendments to the European Commission guidelines on variations categories and procedures

  • Whats is new
  • How will this impact variations in the future

Adriaan Fruijtier graduated as a pharmacist at the University of Utrecht, The Netherlands. Since April 2004 he has been an independent regulatory affairs consultant. Until March 2004 he was Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands and has worked as Manager of Regulatory Affairs at Glaxo, also in the Netherlands.

 

Adriaan has extensive experience implementing filing variations throughout his career and provides regular training on the topic.

 

This course is aimed at professionals who are 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

1 review for

Regulatory Lifecycle Management in The EU (Filing Variations)

13 May 2025 | Short Online Course

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