Pre-course Session: Investigational Medicinal Products (IMP) QP Education Course
Prague, Czech Republic
Course No 16684
Costs
| Non-EQPA/Non-ECA Members: | EUR 990,-- | |
| EQPA/ECA Members: | EUR 890,-- | |
| EU GMP Inspectorates: | EUR 495,-- |
(All prices excl. VAT)
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Susanne Ding, Boehringer Ingelheim, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Brenda Van Assche, Janssen, Belgium
Objectives
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
- Diversity: IMP manufacturers, start-ups, academia…
- 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
- 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
- IMPD, CTA, IND etc.
- Regulatory compliance and the two step release procedure
- Interaction with clinical sites
- Distribution
- IRT
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity