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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?
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.
For questions relative to the ECA Certified Pharmaceutical Development
Manager, please contact
heimes@gmp-compliance.org.
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".
- GMP- and FDA-Compliance in Pharmaceutical Development and IMP
Manufacturing
- Good Development Practice Conference (Part 1)
- Good Development Practice Conference (Part 2)
- GMP meets GCP
- ICH Q8 Master Class - Efficient Use of Quality by Design Elements
- Medicines for Use in Children
- Quality by Design in Analytical Development
To get to the calendar with all courses and conferences currently offered
for this programme - including a link to the contents and a booking form -
please go here.
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