Marketing Authorisation in ASIA, Australia & New Zealand
Termindetails
Wann
18.10.2013 um 17:00
Wo
Kontakttelefon
Teilnehmer
Participants in need of basic know-how regarding the Asian market will especially benefit from the introductory preseminar on day one.
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
You are interested in receiving and maintaining a marketing authorisation in Asia, Australia or New Zealand? Then you shouldn't miss this seminar!
Three experts give you a thorough update on the current regulatory framework of the various countries and the challenges when dealing with the authorities.
If you are in need of basic know-how, we recommend attending the preseminar on day one to gain a thorough understanding of the content discussed in the following seminar (days two and three). Days two and three inform you in detail about the various regions of Asia, including in-depth information on China and the ASEAN countries.
Day four is fully dedicated to Australia and New Zealand and can be booked separately.
May I invite you to create your own tailored training?
