Sprecher
Dr Susanne Ding, Boehringer Ingelheim, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Brenda Van Assche, Janssen, Belgium
Sue Mann, Sue Mann Consultancy, U.K.
Brenda Van Assche, Janssen, Belgium
Zielsetzung
This pre-course online 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.
Hintergrund
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.
Zielgruppe
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “noncommercial” IMP organisations.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
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
- Diversity: IMP manufacturers, start-ups, academia…
Specific legal requirements for IMPs
- Clinical Trial Regulation EU No. 536/2014 and the “old” Annex 13 and Directives 2001/20/EC and 2003/94/C
- The “new” ATMP regulation
GMP meets clinical trials – Differences between IMPs and commercial Products
- Packaging & labeling
- Randomization
- Blinding / placebos
- Comparators
- NIMPs / AMPs
- Where to apply validation activities
- The Product Specification File (PSF)
- 3rd country manufacture of IMPs: import and the QP Declaration
Registration
- IMPD, CTA, IND etc.
- Regulatory compliance and the two step release procedure
GMP/ GDP/ GCP Interface
- Interaction with clinical sites
- Distribution
- IRT
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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