This pre-course session provides a detailed overview of the specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical Trials.
Background
The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore take into account these particularities and the GMP/GCP interface.
Target Group
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Programme
General introduction
Different clinical phases I to IV, focus on patient safety
Undefined processes (manufacture, fit for purpose control strategy, etc.)
Why use risk assessments & how to apply – vital core of a IMP quality system
Testimonials