GOOD CLINICAL PRACTICE WORKSHOP
Good Clinical Practice workshop was conducted on 26.11.2019 at AV hall, Silver Jubilee building between 9.30 AM to 2.00 PM.
The aim of the workshop was to sensitize the core committee members of R & D, members of Central Ethics committee, Institutional Ethics Committee, Institutional Animal Ethics Committee, Internal Quality Assurance cell as well as Ph. D scholars of the Institute and researchers of our Academy about the ICMR guidelines, new clinical trial regulations 2019, ICH GCP and Indian GCP and safety reporting and compensation in clinical trials and various roles and responsibilities of stakeholders.
Master of Ceremony was Dr. Ashwini NS, Deputy Coordinator, R & D, Mr. Bhuneshwar and Mrs. Sai Deepika R, Ph. D Scholars Dept. of Biochemistry.
The inauguration program began with an invocation prayer by Mrs. Suma, Office Secretary of Research & Development section. This was followed by welcome address and introduction of guest speaker by Dr.Shashidhar.K.N, Coordinator R & D.
The Program was inaugurated by watering the plant by dignitaries Dr. Pradeep Kumar G, Honorable Vice- Chancellor, Dr.Shashidhar.K.N, Coordinator R&D and Vice- principal, Dr. Lakshmaiah, Medical Superintendent, Dr. ML Harendra Kumar Coordinator IQAC,
Dr. Sarala N, Director of Academics, Dr. Kalyani, Prof. and Head, Dept. of Pathology, 1 external member from CEC & IEC and Resource Person: Mr. Sudhir A Patel, Chief Operation & Co-Founder, Quinary Clinical Research and Secretary for HECA..
The opening remarks was given by our Dr. Pradeep Kumar G. Vote of thanks was proposed by Dr. Ashwini. N.S.
Profile Summary of the Resource Person:
Mr.Sudhir A Patel a competent Professional with extensive experience in conceptualizing and implementing SOP’s, Process improvement and utilization in clinical operations. He has an extensive expertise in Clinical trial monitoring, writing protocols and designing case report form. He has a sound knowledge about clinical trial and its regulatory requirement; hands on experience in liaising with sponsors and investigator to fulfill regulatory requirements.
He has entrepreneurial experience in leading organization and delivering innovative research techniques.
He has skills in managing designated clinical research studies,
Clinical trial supply in clinical trials and preparation of trial related documentation.
He has led the initiation of QCR as Lead Operation & Co- Founder providing services to the clinical research industry and innovative solution to health care industry needs. He has also steered clinical monitoring with risk based approach. He has excellent interpersonal communication and organizational skills in team management and planning.
Topics covered in the Program:
The session started with
- Discussion on new clinical trial rules and regulations 2019 and principles of GCP.
- Overview of ICH GCP (E6 R2) and GCP
- Role and responsibilities of stake holders (Sponsor/ CRO/EC) as per ICH GCP
- New clinical trial Regulation (EC prospective)
- Safety reporting & compensation in clinical trials.
- ICMR 2017 (Biomedical Health Research Prospective)
- Interactive session case studies etc.., ADR & AE, trial sites, sponsor responsibilities, informed consent, vulnerable subjects, financing and insurance, publication policies from ICH GCP guidelines
- EC registration under CDSCO & DHR,
- Safety reporting and compensation in clinical trials and various roles and responsibilities of stakeholders program also include group activities.
Speaking on the occasion, the participants lauded the efforts taken by Dr. Shashidhar K N and congratulated the team led by Dr. Shashidhar K N for organizing and successfully completing the GCP workshop
The concluding remark was by Dr. Shashidhar. K.N; followed by valedictory function and distribution of certificates to the participants by Guest speaker Mr. Sudhir A Patel, Dr. Shashidhar K.N. Dr. Lakshmaiah and Dr. Harendra Kumar ML.
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