Presented by
Management Forum
EU (European Union) Pharmaceutical Regulations & 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.
★★★★★ "Excellent presenter! Truly professional!"
14-15 October 2024
+ 10-11 February 2025, 9-10 June 2025, 6-7 October 2025 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course Overview
In the 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 becomes indispensable.
Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money. It is therefore important to be aware of potential changes which may impact on strategy.
This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The proposed EU pharmaceuticals legislation changes will be discussed in the relevant sections.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well 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 UK is no longer part of the EU but 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.
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 current EU regulatory environment
· Outline the background to and the proposed EU pharmaceutical legislation changes
· Discuss development strategy and pre-submission activities
· 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
This course will cover:
EU regulatory environment: legal basis
- Key regulations, directives and guidelines
- Proposed EU pharmaceuticals legislation changes Information sources
Information sources
Case Study One
Development and Strategy
- Drug discovery
- Scientific advice
Development process
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies - Phase I to III
EU Clinical Trials Regulation
Types and categories of marketing Authorisations
Adaptive marketing authorisation procedures
The Common Technical Document (CTD)
- Overview of Structure and content of a CTD
Procedures for obtaining a marketing authorisation in the EU and EMA
- The EU centralised procedure
Other EU centralised procedures
- Referral and arbitration
Other procedures for obtaining a marketing authorisation in the EU
- Coordination group
- Decentralised procedure (DCP)
- Mutual recognition procedure (MRP)
- National procedures
Managing product labelling
Case Study Two
Abridged applications and Generics
- Types and Requirements
Product Life Cycle; Post approval
Patents and SPCs
Parallel trade
Post-authorisation obligations; pharmacovigilance, variations and renewals
Pharmacovigilance
Licence variations
- Type I and Type II variations and timelines
- Procedures and timelines
Extensions
Case Study Three
Renewals
Sunset clause
Phase IV Trials
Classification change
Generic development
Strategic factors
Criteria for successful products
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.
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
14-15 October 2024
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 13943
- GBP 1,299
- EUR 1,869
- USD 2,129
- 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
Not ready to book yet?
for 7 days, no obligation
10-11 February 2025
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 14496
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 06 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
Not ready to book yet?
for 7 days, no obligation
9-10 June 2025
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 14736
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 05 May
- 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
Not ready to book yet?
for 7 days, no obligation
6-7 October 2025
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 15001
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 01 Sep
- 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
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 & Strategy training course
Excellent presenter!
Truly professional!
Oct 16 2023
Anastasios Stylianos Karountzos 
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 
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 
Technical Unit Specialist, Alfasigma
Apr 11 2022
Very knowledgeable and patient with questions
Olayinka Oyeneyin 
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
Regulatory Affairs, Bluepharma - Indústria Farmacêutica, SA
Oct 18 2022
Content et presentation very clear
Mathilde Pleurmeau 
Regulatory Affairs Officer, HRA Pharma Rare Diseases
Oct 21 2021
Excellent training session, highly recommended.
Magali Le Goff
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 
Regulatory Affairs Manager, Turgut Pharmaceuticals
Oct 22 2020
Very good knowledge of the topics from the speaker.
Inês Almeida
Regulatory Affairs Manager, BIAL - Portela & C.ª, 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 
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 
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
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
Regulatory Affairs Senior Manager, GSK Consumer Healthcare
Apr 23 2018
Solid content, the form was good, good speaker.
Marion Drouet 
International Product Partner, Roche
Oct 30 2018
Good knowledge of the regulations and good speaker.
Matteo Lapini
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
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
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
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 
Senior Patent Attorney, AstraZeneca
Oct 6 2016
Speaker was personable, knowledgeable good place and tone.
Sorwar Choudhury
Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited
Oct 6 2016
Interesting and very valuable course.
Sofie Stalmans
Regulatory Affairs, PhaRA BVBA
Oct 6 2016
Nice speaker - open for discussion.
Chantal Mutsaers
Regulatory Affairs Scientist, Phara Plus Life Science Services
Oct 6 2016
This kind of overall training covers a lot of topics, that's why it is very interesting.
Sophie Ferruit 
Scientific writer, Monachem
Oct 6 2016
Overview good.
Gregor Schaefer
Medical Therapeutic Area Specialist, Galderma International
United Kingdom
- Alan Boyd Consultants Ltd
- Boots Management Services Ltd
- Carpmaels & Ransford LLP
- Celgene
- Clinigen Group PLC
- Convergence Pharmaceuticals
- Galapagos
- GSK Consumer Healthcare
- HRA Pharma
- HRA Pharma UK & IE Ltd.
- Jazz Pharmaceuticals
- Johnson & Johnson EAME
- KalVista Pharmaceuticals Ltd
- Marie Stopes International
- Martindale
- Meda Pharmaceuticals Limited
- Medreich PLC
- Mundipharma Research Ltd
- Norgine Limited
- Pfizer Ltd
- Recipharm HC Limited
- Shire Pharmaceuticals Development Ltd
- TauRx Therapeutics Ltd
- zaitun ltd
Switzerland
- Acino Pharma AG
- Bioeq AG
- Covis Pharma
- F. Hoffmann-La Roche AG
- F. Hoffmann-La Roche Ltd
- Galderma S.A.
- Galderma SA
- GARDP
- Merck
- Merck Serono
- Mirum Pharmaceuticals Inc
- Nestec SA
- Roche
- Shire International GmbH
Italy
- Alfasigma
- Alfasigma SpA
- Aristea International S.r.l.
- Chiesi Farmaceutical SpA
- Chiesi Farmaceutici S.p.A.
- Chiesi Srl
- Menarini Ricerche s.p.a
- MENARINI RICERCHE SPA
- Seqirus S.r.l
- Sifi S.p.A.
- Zambon SpA
France
- BlueReg
- Boehringer Ingelheim
- Galderma International
- Guerbet
- Horus Pharma
- HRA Pharma Rare Diseases
- Ipsen Pharma
- Septodont
- Voisin Consulting
Belgium
- AESGP
- Argenx
- Galapagos NV
- PhaRA BVBA
- Phara Plus Life Science Services
- PhaRa PLUS Life Science Services (BVBA)
Germany
- Bavarian Nordic
- Bavarian Nordic GmbH
- Bayer Pharma AG
- HEXAL
- medac GmbH
Denmark
- Ferring Pharmaceuticals A/S
- H. Lundbeck A/S
- Novo Nordisk
- Novo Nordisk A/S
Portugal
- BIAL - Portela & C.ª, S.A.
- Bluepharma - Indústria Farmacêutica, SA
- Bluepharma Indústria
- Owlpharma Consulting, Lda.
Netherlands
- Mallinckrodt Medical B.V.
- Mylan B.V.
- Norgine BV
Spain
- Dentaid SL
- Italfarmaco S.p.A.
- Lilly S.A.
Sweden
- AstraZeneca
- Johnson & Johnson
- Johnson and Johnson
Austria
- AOP Orphan Pharmaceuticals GmbH
- Boehringer Ingelheim Regional Center Vienna GmbH & Co KG
Croatia
- Agency for Medicinal Products and Medical Devices
- BELUPO Pharmaceuticals & Cosmetics Inc
Ireland
- Aspen
- Teva
Poland
- Haleon
- Haleon Poland Sp. z o.o.
Slovak Republic
- Ewopharma International s.r.o
- Ewopharma International, s.r.o.
Brazil
- Sanofi
Bulgaria
- Besta Med Ltd.
Czech Republic
- Zentiva Group a.s.
Greece
- Pharmathen
Hungary
- Mylan Hungary Kft
Korea, Republic Of
- AJOU University
Latvia
- AS Kalceks
Monaco
- Monachem
Saudi Arabia
- Saudi Food and Drug Authority
Turkey
- Turgut Pharmaceuticals
United States of America
- Ultragenyx Pharmaceutical Inc.
Run EU Pharmaceutical Regulations & Strategy Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
