Dr Susanne Ding
Boehringer Ingelheim Pharma
Referent:innen
Patryk Jegorow
Takeda
Dr. Sue Mann
Sue Mann Consultancy
Zielsetzung
This pre-course session provides a detailed overview of the basic and 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 consider these particularities and the GMP/GCP interface.
Zielgruppe
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Programm
Gesamtes Programm als PDF herunterladen
Principles of Clinical Trials
- Introduction to Clinical Trials
- Principles involved in;
- API and excipients
- Bulk manufacturing
- Packing and labelling
- QP Certification and batch release - Final Thoughts for the QP
Specific Legal Requirements for IMPs
- Definitions
- Clinical Trial Regulation 536/2014
- Clinical Trial Directive 2001/20/EC
- MD Regulation 2017/745
- IMP Guidelines (various)
- Content of phase appropriate QMS overview
GMP meets Clinical Trials – Differences between IMPs and Commercial Products
- Starting materials – Active pharmaceutical ingredient, excipient, diluent / reconstitution media
- Bulk
- Placebo
- Comparator
- Auxiliary Medicinal Product AxMP
- Trial design, randomization
- Order
- Blinding principles
- Packaging Scenarios
- Labelling
- Exemptions from the manufacturing authorization for packaging & labelling
- Future concepts
IMP Batch Confirmation, QP Certification and IMP Release
- Definitions / Regulations / Guidelines
- IMP Release Process
- Distribution Concept / Controlled Shipment of IMPs
GMP/ GDP/ GCP Interface
- Reconstitution
- Pre-requisites for randomisation and blinding
- Distribution
- Stability and shelf-life extensions
- Trial Master File
- Site to site Transfers
- Complaints and recall
- End of study
- Where does QP responsibility end?
| ECA-Member*: | € 990,- |
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| QP Member Discount*: | € 990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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