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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.

18 September 2024
+ 20 January 2025, 19 May 2025, 16 September 2025 »

from £299

Need help?  Enrol or reserve

Course overview

In the dynamic and highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial 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. This is where a comprehensive understanding of pharmaceutical regulatory affairs is invaluable. 

It is important that companies are aware of proposed changes to pharmaceutical legislation in the EU and the potential impact on company planning and strategy. 

The EU (European Union) on 23rd April 2023 published proposed changes to pharmaceutical legislation. Discussions between the EU Commission, the MS (Member State) and all stakeholders are ongoing. Review by the European Parliament and the EU Council is required before ratification and implementation which is unlikely to be implemented before 2025/2026.

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

The programme will cover current  pharmaceuticals legislation in the EU. The background to the proposed changes in pharmaceuticals legislation will be outlined with discussed in the relevant sections including  proposed changes to procedures for obtaining marketing authorisation in the EU, and post-authorisation data and marketing protection criteria and periods.

 The UK is no longer a member of the EU but 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
  • Discuss the background to and the proposed changes to EU Pharmaceuticals legislation
  • Review current and proposed procedures for applying for a marketing authorisation in the EU/EEA and in the UK
  • Consider post-authorisation data and marketing protection
  • Learn about proposed changes to the EMA responsibilities and function

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 QA

Enrol or reserve

This course will cover:

Introduction of presenter and participants

Aim of course

Background

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

Pre-submission

  • Development advice
  • Discussion re adaptive procedures 

Submission procedures

  • EU procedure for obtaining marketing authorisation and proposed changes 
  • The EMA
  • Centralised Procedure (CP)
  • The Co-ordination Group
  •  Decentralised Procedure (DCP)

Submission procedures (continued)

  •         Mutual Recognition Procedure (MRP)
  •         National procedures 
  •          Including UK procedures

 

Post-authorisation

  • Post-authorisation data and marketing protection and proposed changes
  • Post-authorisation obligations and proposed changes 

Institutional and wider issues

  •         Product supply One Health

  • Environmental protection 

Q&A and discussion

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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

18 September 2024

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 14270

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 14 Aug

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Not ready to book yet?

for 7 days, no obligation

20 January 2025

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 14454

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 16 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

19 May 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 14709

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 14 Apr

View basket 

 
Not ready to book yet?

for 7 days, no obligation

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 299 349
  • EUR 429 499
  • USD 501 579

Until 12 Aug

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.

Isle of Man

  • SEQ Limited
  • SEQ Ltd

United Kingdom

  • Almac Group
  • Theramex

Italy

  • Skillpharma S.r.l.

Spain

  • FAES Farma SA

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy