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EU Pharmaceutical Regulations & Strategy (London, United Kingdom - April 23-24, 2018) - Research and Markets

Research and Markets
Posted on: 18 Dec 17

The "EU Pharmaceutical Regulations & Strategy" conference has been added to Research and Markets' offering.

This course will provide an up-to-date overview of trhe 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.

Agenda:

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
  • Centralised procedure (CP)
  • Decentralised procedure (DCP)
  • Mutual Recognition procedure (MRP)
  • National procedures

Case Study 2: Registration strategy: discussion; will Brexit alter this?

Managing Product labelling

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

    Programme Day Two

Abridged Applications

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

Post Authorisation Obligations and Strategic Considerations

  • Line extension
  • Classification switch
  • Parallel trade (Impact of Brexit)

Obligations

  • Pharmacovigilance
  • Variations
  • Renewals

Safety Reporting

  • Pharmacovigilance

License variations

  • Type I and Type II variations
  • Procedures and timelines
  • Case study 3: Post Authorisation Strategy: discussion; will Brexit alter this?

License Renewals

Requirements and procedures

  • Periodic safety update reports
  • The Sunset Clause

For more information about this conference visit https://www.researchandmarkets.com/research/74c26t/eu_pharmaceutical?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20171218005495/en/

Business Wire
www.businesswire.com

Last updated on: 18/12/2017

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