19.09.2019 22:45:00
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EU Pharmaceutical Regulations & Strategy Programme: Post-authorisation Strategy Discussion - Will Brexit Alter this? (London, United Kingdom, April 20-21, 2020)
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/qj45tz
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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SOURCE Research and Markets
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