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 and GCP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And how do I apply them? What criteria have to be applied for APIs, drug product formulation (including excipients and packaging), analytical methods and stability studies during development?
This Certification Programme has been designed by the ECA to broaden your knowledge and to consolidate the various aspects which need to be considered in a successful development of a new pharmaceutical product.
To receive the certificate, the applicant must attend three out of the following courses / conferences. After attending the third course, the applicant obtains the certificate "ECA Certified Pharmaceutical Development Manager".
For questions relative to the ECA Certified Pharmaceutical Development Manager, please contact email@example.com.