EU Pharmaceutical Regulations & Strategy Course: Registration Strategy Discussion - Will Brexit Alter this? (London, United Kingdom - October 31, 2019 November 1, 2019)

DUBLIN, Sept. 19, 2019 /PRNewswire/ --  The "EU Pharmaceutical Regulations & Strategy" conference has been added to ResearchAndMarkets.com's offering

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

Agenda:

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

For more information about this conference visit https://www.researchandmarkets.com/r/1lsetc

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Research and Markets
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[email protected]

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SOURCE Research and Markets