Key topics:

• Guideline revisions - status quo
• Clinical testing: immunogenicity & bioequivalence
• Safety testing in the pre-authorisation phase
• Worldwide development programmes - US FDA approach, EU approach
• CMC data - comparability data, reference drugs

Please click here for detailed information on Biosimilars 2014.

Key topics:

• National challenges for ATMPs
• EU regulatory framework
• Exchange on to dos for industry
• Marketing Authorisation of ATMPs in the EU and USA
• Development and Marketing Authorisation of ATMP combinational products

Please click here for detailed information on Advanced Therapies 2013

Key topics:

• Essential quality date for clinical trails and MA
• Risk assessment for FIM studies
• Challenges in preclinical and clinical development of originator and biosimilar antibodies
• Extrapolation: A realistic regulatory promise?

Please click here for detailed information on Therapeutic Antibodies.

Key topics:

• European and German framework in Medical Device Law
• Clinical investigation and clinical trial
• Marketing and distribution of medical devices
• Rights and duties of the competent authorities
• Liability and compliance

 Please click here for detailed information on Step by step through Medical Device Law.

Focus: Russia, Belarus, Ukraine, Kazakhstan

Key topics:

• Structure and working procedures of the national authorities
• The application dossier - CTD format?
• SmPC and package leaflet
• The application procedure - timeframes, clock stops, fees
• Maintenance of the marketing authorisation - variations, renewals?

Please click here for detailed information on Marketing authorisation in the CIS countries.

Albania, Croatia, Montenegro, Macedonia, Bosnia & Herzegovina, Serbia and Kosovo

Key topics:

• 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

Brazil, Mexico, Argentinia, Chile, Peru, Venezuela and Colombia

Key topics:

•  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.

Key Topics:

• 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, Australia & New Zealand.

Key topics:

• Marketing authorisation dossier requirements
• Key persons in the countries
• Communication with the national authorities
• Maintenance and product information duties - variations and labelling

Please cklick here for detailed information on Marketing authorisation in North & South Africa.

Key topics:

• Handling pharmacogenetic data
• Use of biomarker as companion diagnostics
• Validation of biomarkers
• From marketing authorisation to the value dossier
• Scientific dissemination of the benefit

Please click here for detailed information on Update Biomarker.

The Decentralised Procedures - an update 2013

Key topics:

• Decentralised procedures: accessible?
• E-submission: the new validation criteria, CMDh best practice guide
• DCP and MRP - challenges in the procedures
• The public assessment report in the light of the EMA transparency initiative
• E-submission of product information

Please cklick here for detailed information on The Decentralised Procedures - an update 2013.