By using an original approach based on extensive feedback from experience, this training course aims to satisfy the following objectives in the specific context of Good Clinical Practice:
- Understand the regulatory requirements of Good Clinical Practices (GCP), in a national and international context (or “Why and when GCPs must be implemented”).
- Understand the ethical requirements: definition of ethics, the underlying principle of clinical tests. What are the practical consequences? Learn ethical requirements at national and international levels. Learn how to protect the volunteer (health, protection of privacy (personal data, confidentiality) etc.)
- Understand the key functions in GCP organisation: The role of the investigator, promoter, monitor.
- Learn how to set up a clinical study and how to ensure that GCPs are complied with, that the data are efficiently collected, etc.
Training Agenda:
- Introduction
- History of Good Clinical Practices (GCP)
- Definitions and genesis of this Quality reference framework: why use the GCP reference framework in the industry?
- Similarities between FDA/EMA regulations and ICH-GCP.
- Differences between FDA/EMA regulations and ICH-GCP.
- Investigator’s responsibilites
- Sponsor’s responsibilities
- Ethical principles and protection of volunteers
- The basic concepts of ethics (Helsinki declaration, Nuremberg code, WHO, etc.). Once these concepts have been learned, GCP requirements become clearer.
- Impact on the measures to be implemented (Ethics Committee, how to draft an informed consent, confidentiality measures, protection of personal data, non inclusion criteria to conform to the rights of the volunteer, etc.)
- Ethics and Conflict of Interest in Clinical Research
- Protection of the volunteers, protection of privacy (personal data, confidentiality)
Who should attend?
This ICH Good Clinical Practice training course is specifically designed for those professionals who need basic and in-depth knowledge in ICH GCP requirements and legislation. The objective is to create awareness and provide advice on the practical issues of GCP as well as to get a better understanding of the regulatory requirements and to raise awareness on possible problem areas.
The training is suitable for:
- Clinical research professionals in the pharmaceutical and biopharmaceutical
- industry, clinical research organizations, and research institutions.
- Investigators
- Clinical Trials Support Staff (e.g staff working in CROs)
- Clinical Research Asociates
- Clinical Research Coordinators
- Clinical Research Management Staff (Project Managers , Medical Directors, , etc)
- Graduates looking to develop a career in clinical research
- Everyone who is interested in networking with other clinical research professionals
Fee:
49 EUR
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Date of Session:
24 November, 2012
Deadline for Registration and Payment:
22 November 2012
Technical Information:
Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.