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.

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 November 2024

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

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)

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