EU Pharmaceutical Regulations & Strategy

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

29-30 Apr 2019

& 31 Oct-1 Nov 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course Overview

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations. It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.

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 EU Marketing Authorisation
  • Discuss Post Authorisation Strategic Considerations and Obligations

Why you should attend

This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post authorisation strategies and obligations.

It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements

Who should attend

This course is for you, particularly if involved in:

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

Programme Day One

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 requirements for sponsor oversight

Applying for a Marketing Authorisation in the EU

  • Fast-track, conditional approval and exceptional circumstances
  • Adaptive licensing
  • Co-ordination Group
  • Registration Procedures:
    - Decentralised Procedure (DCP)
    - Mutual Recognition Procedure (MRP)
    - National

Case Study 2: Registration strategy: Will Brexit alter this?

Managing Product labelling

  • Company core data sheets
  • Updates to Summary of Product Characteristics

Programme Day Two

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

  • Obligations, pharmacovigilance, variations, renewals

Safety Reporting

  • Pharmacovigilance

License 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?

License Renewals

  • PSUR/PBRER Reports
  • The Sunset Clause

Presenter

Norah Lightowler (29-30 Apr 2019)

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

29-30 Apr 2019
29-30 Apr 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
31 Oct-1 Nov 2019
31 Oct-1 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Acino Pharma AG
  • Agency for Medicinal Products and Medical Devices
  • AOP Orphan Pharmaceuticals
  • AstraZeneca
  • Chiesi Farmaceutici S.p.a.
  • Convergence Pharmaceuticals
  • F. Hoffmann-La Roche AG
  • GALDERMA Recherche & Developpement
  • Galderma S.A.
  • GSK Consumer Healthcare
  • HRA Pharma
  • Ipsen Pharma
  • Mallinckrodt Medical B.V.
  • Marie Stopes International
  • Meda Pharmaceuticals Limited
  • medac GmbH
  • Medreich Plc
  • Merck
  • MERIAL - Comptabilité Fournisseurs
  • Nestec SA
  • OPCA Defi
  • PHARA PLUS
  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)
  • Roche
  • Saudi Food and Drug Authority
  • Shire Orphan and Rare Diseases GmbH
  • Voisin Consulting
  • Zambon SpA
  • Zentiva Group a.s.

Overall I found this useful, some content was not so relevant, but a good general overview.

Joanna Fitch, Regulatory Affairs Senior Manager, GSK Consumer Healthcare

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

Norah was clear, open for questions and sympathetic.

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

Solid content, the form was good, good speaker.

Marion Drouet, International Product Partner, Roche

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

Tonia Mazzarella, Regulatory Affairs, Zambon SpA

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

Course content is very comprehensive, cannot recommend any additions. Presentation slides are also very thorough and appropriately referenced. Good speaker but could be more engaging as per previous comments

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

Very useful

Carola Lempke, Senior Patent Attorney, AstraZeneca

The content is up to date, however, lack of detail explanation in each legislation and regulation (but understandably that it will be insufficient to do it in 2days course)

Chin Hooi Yeo, Gx Labelling Specialist, Zentiva Group a.s.

Overview good

Gregor Schaefer, Medical Therapeutic Area Specialist, Galderma International

Interesting and very valuable course.

Sofie Stalmans, Regulatory Affairs, PHARA PLUS

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

Sophie Ferruit, Scientific writer, Monachem

Speaker was personable, knowledgeable good place and tone.

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

Nice speaker - open for discussion

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