- Comparability exercise - the reference as a "moving target"
- Quality issues: quality target product profile
- Clinical testing: bioequivalence, immunogenicity
- Sourcing of originator medication
- Biosimilars: guidelines, current regulatory thinking and health economy
Please click here for detailed information on BiosimilarsFORUM.
- Duties and competences of the MHLW and PMDA
- Regulatory requirements for clinical trials
- Details of the application dossier and the application procedure
- Variations and renewals - the Japanese system
Please click here for detailed information on Marketing Authorisation in JAPAN.
- 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.
- Current changes in the respective national drug laws
- Structure and working procedures of the national authorities
- The application dossier - format & content
- The application procedure - timeframes & fees
- Maintenance - renewals & variations
Please click here for detailed information on Marketing Authorisation in the CIS Countries/Russia.
- The authorities' system
- New drug registration regulation
- Generics drug registration
- Post-approval regulatory processes
Please click here for detailed information on Regulatory Affairs India.
- The CFDA and further authorities, agencies & ministries
- Documents for the application
- Maintenance of the licence
- IP protection
Please click here for detailed information on Regulatory Affairs China.
Albania, Croatia, Montenegro, Macedonia, Bosnia & Herzegovina, Serbia and Kosovo
- Scope of the EU pharmaceutical legislation in practice
- Marketing authorisation application in the Balkan States
- Dossier content and CTD format
- Communication with the national authorities
- Maintenance - renewal & variations
Please click here for detailed information on Marketing Authorisation in the Balkan States
- Current regulatory framework in the Asian countries
- ASEAN: Harmonisation of the Asian drug market?
- China - guidelines and marketing authorisation
- Marketing authorisation for NCEs and generics
- Submission of variations and renewals
- Communication with the authorities
Please click here for detailed information on Marketing Authorisation in ASIA
- 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
- Access to the local markets - preconditions for companies
- Application dossier requirements
- Further obligations: GMP, clinical trials and vigilance
- Application procedures for NCEs, generics, biosimilars ...
- Maintenance duties - renewals and variations
Please click here for detailed information on Marketing Authorisation in Turkey and the CAC Countries.