Investigational Medicinal Products
Tuesday, June 11 – Thursday, June 13 2013
8:00 am – 5:00 pm
Kate Principe 857-350-4811, email@example.com, http://nsf-dba.com/courses/4/investigational-medicinal-products-qlp-module-11
Location: Boston Marriott Cambridge, Cambridge, MA, USA
The manufacture and supply of IMPs presents some unique challenges and there are some significant differences around how GMPs are interpreted through the different phases of clinical manufacture, when compared to commercial products.
Supply of IMPs can often be on the critical path, so it is key that all staff involved have a clear understanding of the current regulatory and GMP/GCP expectations and industry practices.
Whilst regulations and guidances have existed for IMPs for several years, in the EU there has been a significant increase in profile with the implementation of the Clinical Trials Directive. Any US firms supplying IMPs for use in clinical trials overseas need to be fully aware of what this entails.
The adoption of Council Directive 2001/20/EC means that:
- All clinical trials materials must be made in accordance with the principles of GMP, equivalent to EU.
- EU manufacturing facilities must hold an appropriate authorization and will be subject to inspection by the regulatory authorities. Overseas facilities may also be inspected.
- All IMPs must be subject to certification by a Qualified Person prior to release into a trial. This requires knowledge of any made outside the EU.