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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

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.

18-19 Oct 2022

& 20-23 Feb 2023 , 13-14 Jun 2023 , 16-17 Oct 2023

Book or reserve now

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 impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical markets in Great Britain and Northern Ireland will be discussed.

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

Case studies and discussion sessions throughout the two days will explore options and strategies for key regulatory activities and will provide an opportunity to share experiences with our expert trainer and other delegates.

Benefits of attending

  • Understand the legal basis of the EU regulatory environment
  • Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
  • Discuss the impact of Brexit and consequent changes
  • Discuss development strategy and pre-submission activities
  • Discuss post-authorisation obligations and strategic considerations

 

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 in order to gain 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

Programme

EU regulatory environment: legal basis

  • Key regulations, directives and guidelines
  • Impact of Brexit

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

The Common Technical Document (CTD)

  • Overview of Structure and content of a CTD

The European Medicines Agency (EMA)

  • Structure and function

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

  • The EU centralised procedure for marketing authorisation

Other EU centralised procedures

  • Referral and arbitration

Other registration procedures

  • Coordination group
  • Decentralised procedure
  • Mutual recognition procedure
  • 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

  • How the process works
  • Impact of Brexit

 

Post-authorisation obligations; pharmacovigilance, variations and renewals

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

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

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.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
18-19 Oct 2022
Live webinar
09:15-17:00
UK (London)
18-19 Oct 2022
Live webinar
09:15-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 13 Sep*
Enrol now
to attend Live webinar
20-23 Feb 2023
Live webinar
13:30-17:00
UK (London)
20-23 Feb 2023
Live webinar
13:30-17:00
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 16 Jan 23*
Enrol now
to attend Live webinar
13-14 Jun 2023
Face-to-face, Rembrandt Hotel London
13-14 Jun 2023
Face-to-face
Rembrandt Hotel London
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 9 May 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 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
16-17 Oct 2023
Live webinar
16-17 Oct 2023
Live webinar
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 11 Sep 23*
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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

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
  • Alan Boyd Consultants Ltd
  • AstraZeneca
  • Boots Management Services Ltd
  • Carpmaels & Ransford LLP
  • Celgene
  • Clinigen Group PLC
  • Convergence Pharmaceuticals
  • Dentaid SL
  • Ewopharma International, s.r.o.
  • F. Hoffmann-La Roche AG
  • F. Hoffmann-La Roche Ltd.
  • Galderma S.A.
  • GSK Consumer Healthcare
  • Guerbet
  • HEXAL
  • Ipsen Pharma
  • Johnson & Johnson
  • KalVista Pharmaceuticals Ltd
  • Martindale
  • Medreich Plc
  • MENARINI RICERCHE SPA
  • Mundipharma Research Ltd
  • Norgine BV
  • Novo Nordisk A/S
  • OPCA Defi
  • PhaRA BVBA
  • Phara Plus Life Science Services
  • Shire Pharmaceuticals Development Ltd
  • Sifi S.p.A.

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, Apr 22

Very knowledgeable and patient with questions

Olayinka Oyeneyin, Manager Regulatory Affairs, Johnson & Johnson EAME, Apr 22

Excellent training session, highly recommended.

Magali Le Goff, Director Scientific Writing & Regulatory Sciences, BlueReg, Oct 21

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