- Essential quality data for first-in-human clinical trials up to the marketing authorisation
- Risk assessment and mitigation for first-in-human studies
- Management of side effects & immunogenicity as a safety issue
- Quality: laying the foundation for biosimilarity
- Update on progress of EU/US guidelines
- Practical considerations on designing biosimilar clinical studies
- Current regulatory thinking on extrapolation of indications
Please click here for detailed information on Therapeutic Antibodies.
- Legal background for a generic registration
- Current challenges in biosimilar registrations
- Dossier and registration process
- Local bioequivalence studies according to the new Russian guidelines
Please click here for detailed information on RUSSIA: Registration of Generics and Biosimilars
- 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.
- 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.
Focus: Brazil, Argentina, Colombia & Mexico
- Legal framework & national authorities
- National marketing authorisation procedures
- Dossier requirements in Latin America
- Maintenance of the marketing authorisation
Please click here for detailed information on Marketing authorisation in Latin America.
- 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.
- Essential points in the presubmission phase
- The submission: country specialities!
- Multiple/duplicate applications - with case studies
- Delaying and accelerating factors
- E-Submission - eAF & CESP
Please cklick here for detailed information on MR & Decentralised Procedure - Your Regulatory Strategy
- Who follows the ICH or WHO principles?
- Submission strategy based on CPP?
- Role of affiliates, external consultants and agents
- Dossier, submission and maintenance duties
- Rolling out submissions
Please click here for detailed information on Marketing Authorisation Outside the ICH Region.