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EU Pharmaceutical Regulations & Strategy Training Course

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

22-23 Oct 2020

& 19-20 Apr 2021 , 21-22 Apr 2021 , 18-19 Oct 2021 , 21-22 Oct 2021

Book 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 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.

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 an EU marketing authorisation
  • Discuss post-authorisation strategic considerations and obligations

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 Brexit

Development strategy and pre-submission activities

  • Scientific advice
  • Paediatric use

Case study 1: Submission requirements

The Common Technical Document (CTD)

  • Structure and content of the CTD

The EMA

  • Impact of Brexit

Applying for a marketing authorisation in the EU

  • Fast-track, conditional approval and exceptional circumstances
  • Adaptive licensing
  • Centralised procedure

Registration procedures

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

Case study 2: Registration strategy discussion

  • Will Brexit alter this?

Managing product labelling

  • Company core data sheets
  • Updates to SmPC

Abridged applications

  • Legal basis
  • Data exclusivity
  • Generics – definition and criteria

Post-authorisation obligations and strategic considerations

Safety reporting

  • Pharmacovigilance

Licence variations

  • Type I and Type II variations

Strategic considerations

  • Line extensions
  • Classification switch
  • Parallel trade (impact of Brexit)
  • Phase IV studies

Case study 3: Post-authorisation strategy discussion

  • Will Brexit alter this?

Licence renewals

  • PSURs/PBRERs
  • The sunset clause

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 now

22-23 Oct 2020
Live webinar
22-23 Oct 2020
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
19-20 Apr 2021
Live webinar
19-20 Apr 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 8 Mar 21*
Enrol now
to attend
Live webinar
21-22 Apr 2021
Face-to-face, (venue not yet confirmed)
21-22 Apr 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 10 Mar 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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 2021
Face-to-face, (venue not yet confirmed)
18-19 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 6 Sep 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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
21-22 Oct 2021
Live webinar
21-22 Oct 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 9 Sep 21*
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

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
  • Aspen Pharma Trading Limited
  • Bayer Pharma AG
  • BIAL - Portela & C.ª, S.A.
  • Boots Management Services Ltd
  • Clinigen Group PLC
  • Convergence Pharmaceuticals
  • Ewopharma International, s.r.o.
  • F. Hoffmann-La Roche Ltd.
  • GALDERMA Recherche & Developpement
  • Galderma S.A.
  • GSK Consumer Healthcare
  • Johnson & Johnson
  • Meda Pharmaceuticals Limited
  • Medreich Plc
  • Merck
  • MERIAL - Comptabilité Fournisseurs
  • Monachem
  • Mylan
  • Nestec SA
  • Novo Nordisk A/S
  • OPCA Defi
  • PhaRA BVBA
  • Research and Markets
  • Sanofi
  • Seqirus S.r.l
  • Shire Orphan and Rare Diseases GmbH
  • Teva Pharmaceuticals Ireland
  • Zentiva Group a.s.

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

Speaker was personable, knowledgeable good place and tone.

Sorwar Choudhury, Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited, Oct 16

Overview good.

Gregor Schaefer, Medical Therapeutic Area Specialist, Galderma International, Oct 16