DUBLIN--(BUSINESS WIRE)--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
