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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.

The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

21-22 Oct 2021

& 11-12 Apr 2022 , 5-6 Jul 2022 , 18-19 Oct 2022

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Details

Course Overview

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.

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well as discussing the format for presentation of data, the registration procedure and post-authorisation strategic considerations and obligations. The impact of post-Brexit changes on obtaining and maintaining marketing authorisations in the UK will be considered.

There will be a number of case study sessions throughout the two days to explore options and strategies for these key regulatory activities, which will provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.

Benefits of attending

  • Understand the legal basis of the EU regulatory environment
  • 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
  • Explore the impact of post-Brexit changes

Who should attend?

The programme will be of value to regulatory affairs personnel and also to those who interact with regulatory personnel in order to understand 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

Programme

EU regulatory environment: legal basis

  • Key regulations, directives and guidelines and information sources
  • Impact of the end of the Brexit transition period

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 Directive and new Clinical Trials Regulation

Types and categories of marketing Authorisations

The Common Technical Document (CTD)

  • Overview of Structure and content of a CTD

The European Medicines Agency (EMA)

  • Impact of the end of the Brexit transition period

Applying for a marketing authorisation in the EU with discussion on the impact of Brexit

  • The EU centralised procedure

EU centralised procedures

  • Referral and arbitration

Registration procedures

  • Coordination group
  • Decentralised procedure
  • Mutual recognition procedure
  • National procedures

Managing product labelling

Case study two

Abridged applications and Generic

  • Types and Requirements

Product Life Cycle; Post approval

Patents and SPCs

Parallel trade

  • How the process works
  • Impact of the end of the Brexit transition period

Post-authorisation obligations; pharmacovigilance, variations and renewals

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

  • What to expect

Licence variations

  • Type I and Type II variations
  • Procedures and timelines

Extensions

Case study three

Renewals

Sunset clause

Phase IV Trials

Classification change

Generic development

Strategic factors

Successful products

Presenter

Norah Lightowler (More...)

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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Book now

21-22 Oct 2021
Live webinar
21-22 Oct 2021
Live webinar
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
Limited
places

to attend
Live webinar
11-12 Apr 2022
Live webinar
11-12 Apr 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 7 Mar 22*
Enrol now
to attend
Live webinar
5-6 Jul 2022
Face-to-face, (venue not yet confirmed)
5-6 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 31 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
18-19 Oct 2022
Live webinar
18-19 Oct 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 13 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Acino Pharma AG
  • Agency for Medicinal Products and Medical Devices
  • AOP Orphan Pharmaceuticals GmbH
  • Aspen Pharma Trading Limited
  • Boots Management Services Ltd
  • Celgene
  • Clinigen Group PLC
  • Ewopharma International, s.r.o.
  • F. Hoffmann-La Roche AG
  • Galderma S.A.
  • Guerbet
  • HRA Pharma UK & IE Ltd.
  • Ipsen Pharma
  • Johnson & Johnson
  • Marie Stopes International
  • Meda Pharmaceuticals Limited
  • Monachem
  • Mundipharma Research Ltd
  • Mylan
  • Nestec SA
  • OPCA Defi
  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)
  • Roche
  • Sanofi
  • Saudi Food and Drug Authority
  • Shire Orphan and Rare Diseases GmbH
  • Shire Pharmaceuticals Development Ltd
  • Zambon SpA
  • Zentiva Group a.s.

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 20

Very good knowledge of the topics from the speaker.

Inês Almeida, Regulatory Affairs Manager, BIAL - Portela & C.ª, S.A., Oct 20

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, Oct 19

Good knowledge of the regulations and good speaker.

Matteo Lapini, Regulatory Affairs Therapeutic Area Lead, Menarini Ricerche s.p.a, Oct 18

Overall I found this useful – a good general overview.

Joanna Fitch, Regulatory Affairs Senior Manager, GSK Consumer Healthcare, Apr 18

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 18

Norah was clear, open for questions and sympathetic.

Vanina Premus Pogacar, Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices, Apr 18

Solid content, the form was good, good speaker.

Marion Drouet, International Product Partner, Roche, Apr 18

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 17

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, Oct 17

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

Tonia Mazzarella, Regulatory Affairs, Zambon SpA, Oct 17

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

Carola Lempke, Senior Patent Attorney, AstraZeneca, Apr 17

This kind of overall training covers a lot of topics, that's why it is very interesting.

Sophie Ferruit, Scientific writer, Monachem, Oct 16

Nice speaker - open for discussion.

Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services, Oct 16

Interesting and very valuable course.

Sofie Stalmans, Regulatory Affairs, PhaRA BVBA, Oct 16