Good Clinical Practices (GCP) 2019
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve human participants. Attending this GCP course is an essential requirement for any researcher involved in commercial or non-commercial studies. Compliance with Good Clinical Practices principles provides assurance that the rights, safety and well-being of research subjects are protected and that the results of the study are credible. It is highly recommended that GCP training is updated often.
- Event Type:
- Workshops/Training Courses
- Jun. 13-14, 2019
- Mumbai, MH , India
This two days training course designed to cover entire requirements of ICH E6, ICH E3 and Schedule Y and MHRA Good Clinical Practices requirements. To Meet the minimum criteria for International Conference on Harmonisation (ICH) GCP training including: GCP Overview, the Principles of ICH GCP and Investigator responsibilities, and to contribute in fulfilling The FDA expectations for study personnel training.
This seminar will provide an in-depth review of new applications and regulatory topics in clinical research, as well as provide practical tips to assist participants in understanding, applying and successfully complying with Good Clinical Practices guidelines. Professionals who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a “refresh” overview of the GCP process.
- Regulatory Affairs Management and Staff
- Compliance Management and Staff
- Clinical Affairs Management and Staff
- Quality Assurance Management and Staff
- Quality Control Management and Staff
- Clinical Investigators
- Clinical Research Associates
- Clinical Project Managers
- Clinical Study Coordinators
- Clinical Data Management Teams
- IT Personnel working on Clinical Systems