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EU Pharmaceutical Regulations & Strategy (London, United Kingdom - April 20-21, 2020)

  • ID: 4841555
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: April 20-21, 2020
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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
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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
  • Pediatric use

Case study 1: Submission requirements

The Common Technical Document (CTD)

  • Structure and content of the CTD
The EMA
  • Impact of Brexit

Applying for 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
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  • Norah Lightowler Ms Norah Lightowler,
    Management Forum


    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 twentieth year of successful business.

    Norah has wide experience in the pharmaceutical and related neutraceutical, 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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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

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ADDRESS

Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom


DIRECTIONS

The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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