Executive Development Programmes on Good Clinical Practice (GCP) in Clinical Research

Training/Coaching/Tuition by Asian Institute of Public Health Bhubaneswar View Contact

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Course Objectives:
– To understand international rules on medical ethics
– To learn the Indian and international drug development processes
– To acquire skills to carry out different phases of clinical trials
– To provide insights into monitoring, data management, and reporting requirements for conducting studies of the highest quality meeting national and international standard
Topics to be covered: Drug discovery and development process, Pre-clinical studies, Phase I, II, III, IV clinical trials, Ethics in clinical research- historic perspective, International conference on harmonization (ICH), Good clinical practice (GCP) guidelines, IRB/IEC role and responsibilities, Investigator’s role and responsibilities, Sponsor’s role and responsibilities, Regulatory authority’s role and responsibilities, Clinical data management overview, Designing protocols and CRFs, and Reporting of SAEs/AEs. This course will also include mock trials, audits, and reporting.

EDP on Good Clinical Practice (GCP) in Clinical Research (6 Credit units)

Asian Institute of Public Health

The Asian Institute of Public Health is the first of its kind for public health education, research and training located in Bhubaneswar in the state of Odisha, well known for its ancient heritage and vibrant culture. Along with challenges of mining, industrialization and economic development, the state faces serious health problems with high infant and maternal mortality rates among other poor performing indicators. Although in recent times there have been tremendous efforts by the government and non-governmental agencies to fill the perceived and identified gaps, there is a serious need for trained manpower to design, implement, and evaluate health programmes to drive health policies. AIPH was launched to fill this dire need to serve not only the state of Odisha but also other areas within and outside the country where public health capacity building is a priority. The mandate of the institution is to establish an excellent platform for public health education and research with continuous efforts towards creating solutions to local health problems while learning the lessons from innovations across the globe. AIPH emerged from the needs felt and the enormous insights gained by the physicians and public health researchers working in India over the last decade. The efforts started with large scale surveillance of neonatal morbidity and mortality in the community with sophisticated laboratory facilities and nationwide network of research support. These activities were quickly expanded to other domains of public health. These activities were embraced by the Chief Minister of Odisha, national and state health agencies, institutions of higher education in Odisha, and major U.S.-based public health universities. At present, AIPH has earned the support of multiple government and non-government agencies in India.