Future Regulatory Challenges in the Quality Area

Venue: Radisson SAS

Location: Amsterdam, Netherlands

Event Date/Time: Dec 06, 2007 End Date/Time: Dec 07, 2007
Report as Spam


The new ICH Guidelines Q8, Q9 and Q10 have introduced new concepts of manufacturing of drug products quality-by-design, design space and quality systems.
These new concepts will change the regulatory landscape with regard to drug product development and lifecycle management, both for industry and regulators creating opportunities for more flexibility and better cooperation between assessors, inspectors and manufacturing and regulatory personnel.
The Commission intends to embrace these concepts and other simplification proposals in the update of the variation regulation. The challenges of simplification, reduction of regulatory burden while maintaining product quality and safety will be discussed.
The impact of theses changes will be discussed in this quality forum where all parties involved in the discussion on the quality of medicinal products and requirements of drug development, dossier and inspection are brought together to develop a coherent vision on the future regulatory requirements of the quality dossier.


Radisson SAS
Rusland 17