Date: April 5-6

Time: 9am – 4pm

Location: National Institute of Health
Address: Komitas Ave 49/4. 0051 Yerevan

Partners For Patients NGO is proud to be co-hosting, with The Armenian National Institute of Health (NIH) and The Armenia Hematology Association, and The Armenian Medical Association, a 2-day Clinical Trials ICH GCP Educational Seminar.

 

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE Good Clinical Practice (ICH GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

The objective of ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system.

This program has been formulated into five sequential modules to be delivered in a 2-day course. The five modules have been organised to be delivered on April 5-6, 2024. The modules have been selected, evaluated and assessed based on the local clinicians’ feedback (quantitative and qualitative data) collected during preparations of the course.

Health research often involves human participants; hence, it is necessary to respect the rights, safety, and well-being of research participants and ensure that research is conducted with the best possible scientific rigor for generating reliable evidence to inform health policies.

Several guidelines have been developed to promote good research practices, including the Declaration of Helsinki, the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization (WHO), and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.

Compliance is intended to assure that the rights, safety, and well-being of participants are protected, and that trial data are credible. Hence, ICH GCP has been the source of improvement in the quality of clinical trials; however, evidence has shown that there are several limitations to the application of and compliance to GCP in the conduct of academia and non-industry sponsored clinical trials.

Limitations to the applicability of the GCP have been attributed to difficulties in the interpretation of the guidelines, the increased cost of conducting research, the overwhelming documentation process, and a focus on procedural aspects rather than science. In Europe, since the launch of the European Union Clinical Trials Directive, scientists have warned that the new requirements, and added paperwork and costs would hinder trials by academic scientists.

Moreover, most health research falls outside the realm of the ICH GCP regulatory requirement. Despite this fact, some funding agencies, publishers, and ethics committees increasingly expect GCP compliance for non-clinical trial research, likely due to the absence of an alternative guideline for conducting these other types of health-related research.

The clinical trials ICH GCP course is intended to provide an overview and assist national regulatory authorities, sponsors, investigators, and ethics committees in implementing GCP for clinical research in Armenia.

In 2002, the WHO developed the Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation as an adjunct to WHO’s guidelines for GCP for trials on pharmaceutical products.

This will be touched upon in the 2 day course in Yerevan, Armenia at the NIH in Armenia.

We are convinced the training material will be valued with a clear and logical structure; and we will provide working time on exercises to implement the theory into practice.

All participants of this event will receive an ICH GCP certificate.

 

We look forward to offering this pro-bono training to provide the necessary education on the ethical principles and quality standards of health research involving human participants.

If you would like to participate and receive ICH GCP training offered in Armenia register here.