Kenniscentrum Geneesmiddelenonderzoek
About the ‘Kenniscentrum Geneesmiddelenonderzoek’
For advice and support withdrug research the 'Kenniscentrum Geneesmiddelenonderzoek' has a an extensive package of services. Professional pharmacisits with knowledge of current legislation (GCP, GMP) and experience with different therapeutic areas offer support for pharmaceutical industry sponsored as well as investigator initiated trials. Please bear in mind that investigator initiated research involving a medicinal product is often a complex and prolonged process. In the early stages of your project, register your research or get in touch with our hospital pharmacist to discuss what is required. The 'Kenniscentrum Geneesmiddelenonderzoek' offers advise, preparation, storage and distribution of medicinal products, holds a manufacturer of medicines licence and has an exemption for opiates in scientific research. The manufacturer licence is mandatory for those who are preparing medicinal products ( including packaging and labelling) or importing them. Moreover, it is important to know that agreements between the manufacturer and the hospital pharmacy have to be set out in a separate pharmacist’s agreement, which can be appended to the Clinical Trial Agreement (CTA).
Protocol
Each clinical trial aims to answer one or more research questions. To obtain answers to the research questions, it is important to have a solid study design and a well-written study protocol. To ensure the safety and well-being of patients, your study protocol must be approved by the Medical Ethical Review Committee. Our pharmacy team provides assistance in drawing up the study protocol that is both scientifically sound and practically feasible..
Storage and distribution
The ‘Kenniscentrum Geneesmiddelenonderzoek’ has strictly controlled areas that are only accessible to authorized pharmacists and pharmacy assistants. The temperature in the storage areas is continuously recorded and each location is provided with a backup registration by a temperature logger. Full traceability before, during and after an clinical trial is a must/requirement. Drug accountability is maintained on standard forms.
- Conditioned storage environment;
- 2-8°C medication freezer;
- -20°C medication freezer;
- -80°C medication freezer;
- Opiate safe;
- 24-hour surveillance and alarm system with backup logger.
It is possible to make arrangements to have used, opened or expired medicinal products accurately destroyed in accordance with the applicable procedures. Storage outside the pharmacy is possible in consultation with one of our pharmacists.
The ‘Kenniscentrum Geneesmiddelenonderzoek’ distributes investigational medicinal products for multicenter studies to patients at home or to other centers. This is done in accordance with the GDP and GCP guidelines..
Packaging, labeling and import of medicinal products
Activities such as packaging and labeling are subject to a permit requirement. The ‘Kenniscentrum Geneesmiddelenonderzoek’ has this GMP manufacturer's permit for the packaging and labeling of investigational medicinal products. With the help of this license and our experience, we are able to package and label investigational medicines with high quality, fast delivery and in accordance with the latest legislation and regulations.
Our department has the GMP manufacturer's permit for the import of investigational medicinal products and offers you import support. Please note that importing medicinal products outside the EU takes a lot of time.
For more information about these services, please contact one of our pharmacists.
Production / preparation
Due to its many years of experience and extensive network, The ‘Kenniscentrum Geneesmiddelenonderzoek’ has become a specialist in facilitating production.
With its consultancy function, The ‘Kenniscentrum Geneesmiddelenonderzoek’ provides professional advice on the development of investigational medicinal product. This includes advice on the correct form of administration or on the composition of the medicinal product that is appropriate for the design of your trial.
Opiates
The ‘Kenniscentrum Geneesmiddelenonderzoek’ already has an exemption for opiates in the context of scientific research.
If an opiate is not yet included in this exemption, it must be applied for. Please take into account the desired startdate of the study.
Contact
In the early stages of your project register your research or get in touch the ‘Kenniscentrum Geneesmiddelenonderzoek’ via trial.apotheek@amsterdamumc.nl to discuss what is required.