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In-house Training Programme

 
 

Steps from Drug Development to Marketing Authorisation

 
     
 
When What
08.30 – 08.45 h Welcome
08.45 – 09.45 h Phases in API and Drug Development
09.45 – 10.45 h Clinial Trial Application and IMPD
10.45 – 11.15 h Coffee Break
11.15 – 12.15 h Marketing Authorisation Application and CTD
12.15 – 13.15 h Lunch Break
13.15 – 14.15 h Procedures for Marketing Authorisation Applications in the EU
14.15 – 14.45 h Coffee Break
14.45 – 15.45 h Quality Data in IMPD and CTD – What has to be provided?
15.45 – 16.45 h How to deal with Changes/Variations
16.45 – 17.00 h Final Discussion
ca. 17.00 h End of Training Course
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

 

 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging