Do you need an individual offer for your company?
Send us an e-mail indicating your topic(s) of interest.
Please note that we need about 3 months preparation for the organisation of your in-house training course.
|08.30 - 08.45||Welcome|
|08.45 - 09.45||Phases in API and Drug Development|
|09.45 – 10.45||Clinial Trial Application and IMPD|
|10.45 – 11.15||Coffee Break|
|11.15 – 12.15||Marketing Authorisation Application and CTD|
|12.15 – 13.15||Lunch Break|
|13.15 – 14.15||Procedures for Marketing Authorisation Applications in the EU|
|14.15 – 14.45||Coffee Break|
|14.45 – 15.45||Quality Data in IMPD and CTD – What has to be provided?|
|15.45 – 16.45||How to deal with Changes/Variations|
|16.45 – 17.00||Final Discussion|
|ca. 17.00||End of Training Course|