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/
Contacts:
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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1-800-526-8630
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Related
Topics: Drug
Discovery