In-company training can be organised on the following subjects:
- Introduction ICH GCP guideline
- Clinical research in general
- Regulatory requirements for clinical research in the Netherlands
- Regulatory requirements for clinical research in Europe
- History and infrastructure of clinical research in the Netherlands
- Plain Common Sense Guideline with questions from daily research practice and cases
- Organization of research in the hospitals and in industry
- Building and managing a Trial Bureau within an Academic Center or a hospital
- Audits and Inspections
- How to deal with suspected fraud
- Reporting of serious adverse events and adverse drug reactions to the authorities
- Design of study archives
- Role, tasks and responsibilities of an accredited Ethics Committee in general and the Ethics Committee in the Netherlands since the implementation of the Medical Research Involving Human Subjects Act
- The pharmacist and clinical research
- Informed consent procedure
- Patient recruitment techniques
- Communication skills training courses focusing on clinical research
- Other Applicable regulatory requirements for clinical research in the Netherlands (Privacy laws)
- The Medical Research Involving Human Subjects Act in daily practice
The Profess ICH GCP training course has been accredited by the accreditation committee for medical specialists for 8 points
If you are interested to know more about our company and expertise, or discuss how we can organise for you a custom-made training programme, please contact us: info@profess.nl