EU (European Union) Proposed Pharmaceutical Legislation Changes In-house Training

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.

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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 proposed changes, published by the Commission in April 2023, were followed by significant lobbying from the pharmaceutical industry. The European Parliament’s position was published in March 2024, and the Council agreed its position on 4 June 2025. A political agreement between the Council, the European Parliament, and the Commission was reached on 11 December 2025.

The final text now requires formal endorsement by both the European Parliament and the Council before it can be published in the Official Journal, which is expected in Q2 2026. Implementation and transitional arrangements will follow.

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.

Please note:

This programme has been designed to reflect an understanding of the EU regulatory landscape for medicinal products, as well as the current status and implementation of proposed legislative changes. Content will be delivered using the most up-to-date information available at the time of presentation.

Attendees can expect a clear overview of the current position, along with discussion of implementation and transition timelines and the associated regulatory impact.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

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

Popular with...

This course has proven particularly popular among our customers in these roles:

Head of Regulatory Affairs
Regulatory Affairs
Regulatory Affairs Manager
Regulatory Affairs Specialist
Senior Regulatory Affairs Associate

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

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.

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