Profess Medical Consultancy B.V has been certified by the accreditation committee of the Quality Register V&V (Nursing and Care-takers). The Profess ICH GCP training course has been accredited by the accreditation committee for medical specialists for 8 points.
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 (General Data Protection Regulation)
- The Medical Research Involving Human Subjects Act in daily practice
All courses are interactive. This means that case histories, problems from daily practice and exercises are an integral part of the training course. Each course can be completed with a qualification test and subsequently a qualification certificate. If no qualification test will be given then the participant will receive a certificate of attendance.
We will discuss and agree upon the scope of the training, the programme and logistics. We will request you to prepare an inventory of day-to-day problems of the participants concerning the selected training subject. We will develop the training materials in which your needs and problems are integrated and provide the training, thereby employing experienced trainers and making sure that all the participants receive a training hand-out.
N.B. All courses can be provided in English and Dutch. Some courses can be provided in the German language.