Die Themen

• Current regulatory framework in the Asian countries
• Marketing authorisation for NCEs and generics
• Submission of variations and renewals
• Communication with the authorities - meetings?
• ASEAN: Harmonisation of the Asian drug market?

Ziele

Two experts in drug regulatory affairs will give you a thorough update on the current regulatory framework of the various Asian countries.

• What kind of (study) data do you need when applying for a marketing authorisation?
• What are the challenges when applying for an NCE or a Generics marketing authorisation?
• How can you communicate with the authorities?
• How can you assure the maintenance of a granted marketing authorisation?

These and many more questions will be addressed during the two seminar days. Will you join us?

Ihre Referenten