This event is the first in Europe to focus on the practical application of the concept of Quality by Design (QbD) to the pharmaceutical development and manufacturing of generic medicines.
It will offer a unique discussion platform for the generic medicines industry and regulators to gain essential updates and clarification on technical elements of QbD, as well as QbD’s regulatory implications.
The programme will include keynote speeches from the CHMP/CVMP Quality Working Party as well as experts from regulatory authorities and the generic medicines industry. The US FDA Office of Generic Drugs will be invited to share their view. Strong emphasis will be put on providing case studies.
ISPE's First Conference on Quality by Design for Generic Medicines is organised in conjunction with the EGA - European Generic Medicines Association
The NEW ISPE PQLI® from Concept to Continual Improvement (Part 1 and Part 2) will be integrated into the content of the various workshop sessions and complimentary electronic copies of both publications will be given to each attendee.
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