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Management Forum

EU (European Union) Pharmaceutical Regulations and Strategy Training Course

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation will be discussed in the relevant sections and impact on strategic considerations for obtaining and maintaining marketing authorisations Procedures for obtaining marketing authorisations in in the UK will be discussed.

★★★★★ "Overall, it was a wonderful webinar and has helped me further expand my knowledge on the EU/UK regul... more (26)"

2-3 March 2026
+ 5-6 October 2026 »
from £1299

Need help? Enrol/reserve

Course overview

In the 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.

Creating and coordinating an effective regulatory strategy is an important part of the work of a regulatory affairs department and can save valuable time and money. It is therefore necessary to be aware of potential changes and new procedures and methodologies which may impact on planning and strategy.

This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations. The background to the proposed EU pharmaceuticals legislation revision in the key areas will be discussed .

The programme will cover the legal basis of EU regulation, development strategies and the importance of pre-submission activities, a brief overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations. The increasing use of AI in product development, manufacturing and post-authorisation activities will be considered in the relevant sections.

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

Case study sessions will explore options and strategies for key regulatory activities and provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.

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 current EU regulatory environment
Outline the background to and the proposed EU pharmaceutical legislation changes in the identified key areas
Discuss development strategy and pre-submission activities and the use of AI
Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
Discuss post-authorisation strategic considerations and obligations

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 information requirements. It will be particularly relevant to all those working in:

Regulatory affairs
Project management
Business planning
Commercial management
Manufacturing and QA
Labelling and artwork
Medical information
Clinical
Pharmacovigilance

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

2-3 March 2026

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15812

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 26 Jan

2 days 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

5-6 October 2026

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 16390

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 31 Aug

2 days 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.

Reviews of IPI's EU Pharmaceutical Regulations and Strategy training course

Overall, it was a wonderful webinar and has helped me further expand my knowledge on the EU/UK regulations. I look forward to participating in future webinars.

Feb 10 2025

Iva Martinovic Croatia
Medical Information Professional, Teva

Feb 10 2025

Very Good. I wanted to get an overview of EU Pharmaceutical Regulations and to understand regulatory strategies to bring new products quickly into the market. The course covered everything I needed and even more.

Chitra Saxena United Kingdom
Senior Manager Regulatory Affairs, Lupin Healthcare (UK) Limited

Oct 16 2023

Excellent presenter! Truly professional!

Anastasios Stylianos Karountzos Greece
Regulatory Affairs Officer, Pharmathen

Oct 16 2023

Good overview of the Pharmaceutical Legislation and interesting summary of future changes in the legislation framework. Case studies were a good opportunity to discuss regulatory strategies.

Adriana Lopes Portugal
Regulatory Affairs, Bluepharma Indústria

Oct 18 2022

Overall it was a good webinar that covered a wide range of topics essential for professionals working in or close to regulatory affairs

Sara D'Onofrio Italy
Technical Unit Specialist, Alfasigma

Apr 11 2022

Very knowledgeable and patient with questions

Olayinka Oyeneyin United Kingdom
Manager Regulatory Affairs, Johnson & Johnson EAME

Apr 11 2022

Good overview of the regulatory topics concerning the product life-cycle. Availability to clarify and discuss doubts; challenge of the participants mind set;

Maria Inês Versos Portugal
Regulatory Affairs, Bluepharma - Indústria Farmacêutica, SA

Oct 18 2022

Content et presentation very clear

Mathilde Pleurmeau France
Regulatory Affairs Officer, HRA Pharma Rare Diseases

Oct 21 2021

Excellent training session, highly recommended.

Magali Le Goff France
Director Scientific Writing & Regulatory Sciences, BlueReg

Oct 22 2020

The webinar was really ideal for persons/companies willing to register their product in the EEA. The speaker was also excellent, involving the attendants with her particular questions, which provided a broader content.

Gokce Erdem Turkey
Regulatory Affairs Manager, Turgut Pharmaceuticals

Oct 22 2020

Very good knowledge of the topics from the speaker.

Inês Almeida Portugal
Senior Regulatory Science Specialist, BIAL - Portela & Cª, S.A.

Oct 31 2019

Very good and comprehensive overview of the EU regulations with an emphasis on MAA. I particularly liked the case studies where we implemented what we had learnt – a very good way of checking if the material is understood.

Natalie De Jonge Belgium
Regulatory affairs Manager, Argenx

Apr 23 2018

Norah was clear, open for questions and sympathetic. It helped to connect lots of the regulatory knowledge i had

Vanina Premus Pogacar Croatia
Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices

Apr 23 2018

I got what I expected. An overview of pharmaceutical legislation, speaker was great with huge knowledge.

Danijela Jurisic Croatia
Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices

Apr 23 2018

Overall I found this useful – a good general overview.

Joanna Fitch United Kingdom
Regulatory Affairs Senior Manager, GSK Consumer Healthcare

Apr 23 2018

Solid content, the form was good, good speaker.

Marion Drouet Switzerland
International Product Partner, Roche

Oct 30 2018

Good knowledge of the regulations and good speaker.

Matteo Lapini Italy
Regulatory Affairs Therapeutic Area Lead, Menarini Ricerche s.p.a

Oct 30 2017

Very useful course to improve the understanding of European Requirements and the different types of procedures

Tonia Mazzarella Italy
Regulatory Affairs, Zambon SpA

Oct 30 2017

Course content is very comprehensive and the presentation slides were also very thorough and appropriately referenced. Good speaker.

Suna Horner United Kingdom
Associate Medical Manager, HRA Pharma UK & IE Ltd.

Oct 30 2017

The course was informative, comprehensive and interactive. The venue was fantastic and Management Forum was well organised. The entire course was well put together. Brilliant experience!

Evelyn Olasegha United Kingdom
Senior Manager Regulatory Affairs, Mundipharma Research Ltd

Apr 6 2017

Very useful. The speaker was warm and very knowledgeable and I particularly liked the interactive style.

Carola Lempke Sweden
Senior Patent Attorney, AstraZeneca