This course is designed to help students and researchers to better understand various regulations with respect to Clinical trials and their applications, pharmacovigilance, research study design, ethical principles, challenges, Building an ethical approach, compensation, and ethical governance that apply to New clinical trial regulations Learning Outcome: 1. Understanding latest new clinical trial regulations 2. Laws, policies, and principles that apply to use of clinical trials 3. Key ethical principles for research conduct 4. Ethical challenges and research study design 5. Building an ethical approach drug safety 6. Compensation and informed consent process in clinical trials. 7. Advanced artificial intelligence applications in clinical research and pharmacovigilance
Course Details
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Definitions and General Principles and Practices for Clinical Trial Ethics Committee for Clinical Trial: • Requirement of the Ethics Committee Constitution of Ethics Committee for clinical trial, • Registration and Validity of Ethics Committee · Functions of Ethics Committee
· Grant of permission to conduct clinical trial · Academic clinical trial · Inspection of premises relating to clinical trial · Suspension or cancellation of permission to conduct clinical trial
Procedure for compensation in case of injury or death during clinical trial Manufacture of New Drugs or Investigational New Drugs for Clinical Trial Contents of the proposed protocol for conducting clinical trials and Structure, content and format for clinical trial report
Stability Testing of New Drugs Animal toxicology (Non-clinical toxicity studies) CTRI SUBMISSION
Undertaking by the investigator, Investigator's brochure Pharmacovigilance overview Post market assessment Data elements for reporting serious adverse events occurring in a clinical trial
Experimental design Observational Study design CASE STUDIES STUDY DESIGN
Learn from leading experts in stem cell research
Working as Professor, Dept of Pharmacy Practice with more than 17 years of experience in clinical research/biomedical ethics/evidence-based medicine, antibiotic stewardship programs, pharmacovigilance, drug safety, clinical trials, and outcome research. Dr Kanav Khera is also an associate member secretory of the Institutional Ethics Committee at School of Pharmaceutical Sciences, LPU. Dr Kanav Khera had vast experience in providing pharmaceutical care services in Tertiary care hospitals and handling medication errors and related problems. Had published more than 40 research papers in national and international journals and was invited as a guest speaker at various events. Dr Kanav Khera has been honoured with Best teacher and excellence in teaching awards and and also worked as Scientist 1 in a clinical research organization conducting clinical trials
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