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EU (European Union) Proposed Pharmaceutical Legislation Changes Training Course

A Regulatory Update

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

22 May 2024
+ 18 September 2024 »

from £299

Need help?  Enrol or reserve

Overview

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

The UK is no longer a member of the EU but knowledge of interactions and collaboration with the EU are important for obtaining and maintaining marketing authorisations in the UK and the EU.

The programme will cover the current legal basis of pharmaceuticals regulation in the EU and proposed changes in pharmaceuticals legislation. The proposed changes in procedures for obtaining marketing authorisation in the EU and post-authorisation data and marketing protection will be considered. The changes in the role and responsibilities of the EMA will be discussed.

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 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. 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

The EU Proposed Pharmaceutical Legislation Changes course will cover:

Introduction of presenter and participants

Aim of course

Background

  • Background to proposed EU legislation changes
  • EU regulatory environment
  • 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 
  • Centralised Procedure (CP)

Submission procedures (continued)

  • Decentralised Procedure (DP)
  • Mutual Recognition Procedure (MRP)
  • National procedures 

Post-authorisation

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

Institutional and wider issues

  • The EMA
  • One Health
  • Environmental protection 

Q & A and discussion

Enrol or 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

22 May 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 14269

  • GBP 349
  • EUR 499
  • USD 579

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Not ready to book yet?

for 7 days, no obligation

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

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

Italy

  • Skillpharma S.r.l.

United Kingdom

  • Theramex

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