Introduction to International Regulatory Affairs
Part I – European
Union |
Regulation of
Development and Marketing of Prescription Pharmaceuticals
- Legal basis of international regulation of
pharmaceuticals
- Structure and function of EU and member countries
regulatory agencies
|
European Union – Strategy,
Working with Agencies, Sources of Regulations,
Guidelines etc.
- Role of EMA and the CMP (pharmacovigilance,
centralized, arbitration, working parties)
- European Commission decision making process
- Outline of centralized and decentralized procedures
- Scientific vs. National advice
- Timelines/clockstops: how to navigate
|
The Clinical
Trials Directive
- European Union procedures & roles of agency
in CTD
- Preclinical, clinical, chemistry/manufacturing
requirements
- Differences in data requirements across territories
- Role of Ethics Committees
|
Marketing Authorization
Applications –European Union & Other
European Countries
- “Uncommon technical document”-
differences, regional requirements, alleged harmonizations
- Dossier, outline of application options
- centralized vs. mutual recognition
- Europe – Variations
- CTD and electronic applications <more>
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