- Key objectives of the revised legislation
- Provisions for marketing authorisations - just benefits?
- The future of product maintenance
- Extended data protection - a way to encourage innovation?
- Pharmacovigilance database - effective simplification?
Please click here for detailed information on Better Regulation for Veterinary Medicinal Products.
- Get an in-depth insight into the role of phytopharmaceuticals in the different healthcare systems
- Understand the various marketing authorisation procedures and the current challenges
- Get an update on the legislative changes in the regions
- Get practical hints for your product maintenance
Please click here for detailed information on Phytopharmaceuticals: Regulatory Affairs in Eastern Europe/Russia & China.
- Quality data for the dossier - the formats
- Pharmaceutical documentation for Latin America, Russia and Asia
- Country-specific requirements - import testing
- Global stability programmes
- CMC lifecycle management
Please click here for detailed information on Global CMC Requirements.
- US FDA regulations in comparison with the EU law
- The FDA drug registration in detail
- Communication with the FDA
- Marketing authorisation granted - the arising duties
- Case Study - how FDA approves oncological products
Please click here for detailed information on FDA: Marketing Authorisation in the U.S.
- Free writing versus regulatory restrictions
- Writing and reviewing regulatory documents
- Editing and proofreading documents
- Package leaflet - regulatory linguistic restrictions and user-friendly writing
- Good writing skills - example: clinical overviews and summaries
Please click here for detailed information on Scientific Writing and Reviewing in Regulatory Affairs