- 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.
- 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
- MENA, a good market for generics and biosimilars?
- The concept of supergenerics and biobetters
- Marketing authorisation documents and procedures
- Data protection in MENA - regulatory peculiarities for generics and biosimilars
Please click here for detailed information on Generics and Biosimilars in MENA
- 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.
- E-only - when mandatory in the EU?
- Two years of CESP - lessons learnt
- Implementation of the ISO IDMP standards
- Impact of the IDMP on regulatory affairs and pharmacovigilance
- The XEVMPD - the aftermath of December 2014
- XEVMPD maintenance: simple change, major impact
Please click here for detailed information on The "e"-Challenges: The IDMP, XEVMPD and eSubmission.