DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/7376dk/abridged) has announced the addition of the "Abridged Applications - The Regulator and the Industry View" conference to their offering.
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
- Participants will receive a course material folder containing comprehensive documentation provided by the speakers, which will be a valuable source of reference for the future.
- A Certificate of Attendance for Professional Development will be given to each participant who completes the course
- This seminar has been accredited as being suitable for 5.5 hours per day of continuing professional development by The CPD Certification Service.
For more information visit http://www.researchandmarkets.com/research/7376dk/abridged