Abridged Applications - The Regulator and the Industry View Seminar (London, UK - October 14-15, 2015)
DUBLIN, Sept. 1, 2015 /PRNewswire/ -- Research and Markets (http://www.researchandmarkets.com/research/6sdpjt/abridged) has announced the addition of the "Abridged Applications (London, UK - October 14-15, 2015)" conference to their offering.
Abridged Applications - The Regulator and the Industry View
This seminar is concerned with the current aspets of abridged applications and will include information on any new issues or problems arising in relation to these applications.
Safety, quality and efficacy will be addressed in an integrated fashion and the importance of application registration planning will be stressed.
A basic knowledge of the application procedure will be assumed.
Topics To Be Covered
- The current legislation associated with Abridged Applications
- Quality issues
- Bioequivalence, BCS Classification and Biowaiver
- Clinical Issues and data requirements
- Pharmaceutical Issues
- Drug substance data, European drug master files and CEPs
- The Summary of Product Characteristics (Clinical, pre-clinical and quality)
- Paediatrics RM and Abridged Applications
For more information visit http://www.researchandmarkets.com/research/6sdpjt/abridged
Media Contact:
Laura Wood, +353-1-481-1716, press@researchandmarkets.net
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