EU Pharmaceutical Regulations & Strategy

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

20-21 Apr 2020

& 22-23 Oct 2020

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. 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.

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.

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?

This course will be of particular relevance if you are involved in:

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

Programme day one

Welcome and introduction

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 (CP)

Case study 2: Registration strategy discussion

  • Will Brexit alter this?

Programme day two

Registration procedures

  • Co-ordination group
  • Decentralised procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National procedures

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

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

20-21 Apr 2020
20-21 Apr 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
22-23 Oct 2020
22-23 Oct 2020 Cavendish 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...

  • Agency for Medicinal Products and Medical Devices
  • AOP Orphan Pharmaceuticals
  • Argenx
  • Aspen Pharma Trading Limited
  • Chiesi Farmaceutici S.p.a.
  • Convergence Pharmaceuticals
  • F. Hoffmann-La Roche Ltd.
  • Galderma S.A.
  • Guerbet
  • Ipsen Pharma
  • Johnson & Johnson
  • Meda Pharmaceuticals Limited
  • medac GmbH
  • Medreich Plc
  • Merck
  • Monachem
  • Mundipharma Research Ltd
  • Mylan
  • Mylan Hungary Kft
  • Nestec SA
  • Novo Nordisk A/S
  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)
  • Roche
  • Saudi Food and Drug Authority
  • Seqirus S.r.l
  • Shire Pharmaceuticals Development Ltd
  • Teva Pharmaceuticals Ireland
  • Zambon SpA
  • Zentiva Group a.s.

Good knowledge of the regulations and good speaker

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

Solid content, the form was good, good speaker.

Marion Drouet, International Product Partner, Roche

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

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

Norah was clear, open for questions and sympathetic.

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

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

Tonia Mazzarella, Regulatory Affairs, Zambon SpA

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.

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

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.

Very useful

Carola Lempke, Senior Patent Attorney, AstraZeneca

Speaker was personable, knowledgeable good place and tone.

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

Overview good

Gregor Schaefer, Medical Therapeutic Area Specialist, Galderma International

Nice speaker - open for discussion

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

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

Sophie Ferruit, Scientific writer, Monachem

Interesting and very valuable course.

Sofie Stalmans, Regulatory Affairs, PhaRA BVBA