2-Day Course: EU Pharmaceutical Regulations & Strategy (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com

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.

It will be of value for regulatory affairs personnel and also for 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

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

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
  
  Impact of Brexit
  
  Applying for a marketing authorisation in the EU

• Fast-track, conditional approval and exceptional circumstances
• Adaptive licensing
• Co-ordination group
• Centralised Procedure (CP)

Case study 2: Registration strategy discussion

Will Brexit alter this?

Programme Day Two

Registration procedures

• 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/research/hpn79p/2day_course_eu?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005307/en/