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Management Forum

EU (European Union) Proposed Pharmaceutical Legislation Changes Training Course

A Regulatory Update

This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.

16 September 2025
+ 19 January 2026, 1 July 2026 »
from £350

Need help? Enrol/reserve

Course overview

In the dynamic and highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is invaluable for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging and a comprehensive understanding of current and proposed revisions of pharmaceutical legislation is important.

The EU (European Union) on 23rd April 2023 published proposed revision of pharmaceutical legislation. Discussions between the EU Commission, the MS (Member State) and all stakeholders are ongoing. The European Parliament adopted their position on 10th April 2024. EU Council ratification is required before implementation which is unlikely to be before 2025/2026.

Developing products is a lengthy process and the cost of developing new and modified products is increasing. It is therefore important that companies are aware of procedures and timelines for obtaining marketing authorisations and to know what if any post approval data and marketing protection will be available.

The background to and main objectives of the proposed changes in pharmaceuticals legislation will be outlined.

The UK is no longer a member of the EU but it is still a major pharmaceuticals market and knowledge of interactions and collaboration with the EU and other regulatory agencies are essential for obtaining and maintaining marketing authorisations in the UK.

The format will provide opportunities for discussion and for sharing of concerns and experiences with our expert trainer and other delegates.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

Understand the legal basis of the EU regulatory environment
Learn about the background to and reasons for the proposed revision of pharmaceuticals legislation in the identified key areas
Review current and proposed modifications to procedures for applying for a marketing authorisation in the EU/EEA and in the UK
Consider post-authorisation obligations and data and marketing protection

Who should attend

The course is designed primarily for regulatory affairs personnel however, it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and strategic factors in obtaining and maintaining marketing authorisations.

It will be of interest to personnel working in:

Regulatory affairs
Project management
Business planning
Commercial management
Labelling and artwork
Medical information
Manufacturing and QC

Enrol/reserve

This course will cover:

Introduction of presenter and participants

Aim of course

Background

Background to proposed EU legislation revision
Proposed changes to EU pharmaceuticals legislation

Pre-submission

Development advice
Discussion re adaptive procedures

Submission procedures (summary of current with proposed changes)

EU procedure for obtaining marketing authorisation and proposed changes
The EMA
Centralised Procedure (CP)
The Co-ordination Group
Decentralised Procedure (DCP)
Mutual Recognition Procedure (MRP)
National procedures (Including UK procedures)

Post-authorisation (summary of current with proposed changes)

Post-authorisation data and marketing protection
Post-authorisation obligations

Institutional and wider issues

Product supply
One Health
Environmental protection
Increasing use of AI in development, manufacturing and post-authorisation

Q&A and discussion

Enrol/reserve

Norah Lightowler
Lightowler Associates

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

16 September 2025

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14927

GBP 400
EUR 560
USD 640

3 hours live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

19 January 2026

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 15758

GBP 350 400
EUR 490 560
USD 562 640

Until 15 Dec

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

1 July 2026

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 16324

GBP 350 400
EUR 490 560
USD 562 640

Until 27 May

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.