ICH - International Conference on Harmonization has prescribed the international high quality standards and harmonized guidelines, shortly known as ICH-GCP, to be followed by the various stakeholders like the investigators, industrial and academic trial sponsors, monitors (Clinical Research Associates) and Institutional Review Boards (IRBs) for good clinical practice. The governments have accordingly formulated regulations for the clinical trials wherever human subjects are involved.
The guidelines deal with clinical study and its ethical aspects, clinical trial protocol, its amendments, roles of the clinical trial sponsors and their responsibilities. They encompass various aspects relating to monitoring, collection of quality data, reporting, record keeping, archiving clinical trials, training and other facilities. They also deal with the incorporation of addenda in the Essential Documents/ Investigator’s Brochure. Inspections will ensure quality assurance, safety, efficacy of the newly introduced compounds and that the specified standards are really accomplished.
The ultimate purpose of the good clinical practice is to ensure the scientific authenticity of the studies and the clinical properties relating to the investigational products are documented in a proper manner. With the chief objective of protecting the human rights and preserving them, the international communities have been applying these practices in all their clinical trials.
GCP training will contain the comprehensive and current principles of ICH-GCP, leading to professional certification, besides serving the other purpose of CPD (Continuous Professional Development). It will review and demonstrate those principles, including the regulations of the MHRA, as per the ICH guidelines. The training will be imparted by the professional trainers, who enjoy enough experience in the highest levels. The courses will help you to learn and develop the skills in this area. The courses are conducted online (meaning anytime, anywhere training), besides the classroom courses – whether full time or even part time and for different durations, to accommodate the convenience of the participants. When the training is online and from some international institute, the course will be translated in the language of your country; also the curricula will be designed country-specific.
The curricula will comprehensively cover all the aspects, as per the standards prescribed by the ICH in relation to GCP and also will be up to date, considering the amendments then and there. There may be different courses to cover the specific aspects say one focusing on ICH, another focusing US FDS and another on Investigational drugs/ medical devices/ biologic.
The GCP training course will be necessary for the staff on the clinical research side of the medicine, CRO – Contract Research Organizations and other related research organizations in drugs and devices and biologics. Further, investigators, monitors staff of the sponsors, support staff of clinical trials, research nurses members of ethics committee will certainly find this training as brushing up their knowledge and skills.
The guidelines deal with clinical study and its ethical aspects, clinical trial protocol, its amendments, roles of the clinical trial sponsors and their responsibilities. They encompass various aspects relating to monitoring, collection of quality data, reporting, record keeping, archiving clinical trials, training and other facilities. They also deal with the incorporation of addenda in the Essential Documents/ Investigator’s Brochure. Inspections will ensure quality assurance, safety, efficacy of the newly introduced compounds and that the specified standards are really accomplished.
The ultimate purpose of the good clinical practice is to ensure the scientific authenticity of the studies and the clinical properties relating to the investigational products are documented in a proper manner. With the chief objective of protecting the human rights and preserving them, the international communities have been applying these practices in all their clinical trials.
GCP training will contain the comprehensive and current principles of ICH-GCP, leading to professional certification, besides serving the other purpose of CPD (Continuous Professional Development). It will review and demonstrate those principles, including the regulations of the MHRA, as per the ICH guidelines. The training will be imparted by the professional trainers, who enjoy enough experience in the highest levels. The courses will help you to learn and develop the skills in this area. The courses are conducted online (meaning anytime, anywhere training), besides the classroom courses – whether full time or even part time and for different durations, to accommodate the convenience of the participants. When the training is online and from some international institute, the course will be translated in the language of your country; also the curricula will be designed country-specific.
The curricula will comprehensively cover all the aspects, as per the standards prescribed by the ICH in relation to GCP and also will be up to date, considering the amendments then and there. There may be different courses to cover the specific aspects say one focusing on ICH, another focusing US FDS and another on Investigational drugs/ medical devices/ biologic.
The GCP training course will be necessary for the staff on the clinical research side of the medicine, CRO – Contract Research Organizations and other related research organizations in drugs and devices and biologics. Further, investigators, monitors staff of the sponsors, support staff of clinical trials, research nurses members of ethics committee will certainly find this training as brushing up their knowledge and skills.
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