European QP Association (EQPA), KisselPharmaConsulting
Katja Kotter
Vetter Pharma-Fertigung
Note: All times mentioned are CET.
Objectives
During this Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and Investigational Medicinal Product (IMP) Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.
Background
Not only in the manufacturing of marketed products (c)GMP Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And what is the role of ICH Q8, Q9, Q10 and Q12?
With the third revision of ICH E6 (ICH E6(R3)), the GMP for IMP principles will be expanded to the following: Adequate measures to ensure that the investigational product is handled and shipped appropriately should be implemented.
Previously, the WHO already published two documents relating to Development and GMP for IMPs: „Good Practices for Research and Development Facilities of Pharmaceutical Products” and „GMP for IMPs“.
In addition, instead of the current EU GMP Annex 13 (Manufacture of IMPs), the Detailed Commission guidelines on GMP for IMPs for human use apply.
Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.
This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.
Target Group
This course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.
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Testimonials
Seminar Programme as PDF