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What you'll learn

Description: This course is designed to: Help Students and researcher to better understand various regulations with respect to Clinical trials and its Applications, pharmacovigilance, research study design, ethical principles, challenges, Building an ethical approach, compensation and ethical governance frame work 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

  • ·  Clinical trial of new drug or investigational new drug, Application for permission to conduct clinical trial of a new drug or investigational new drug, Grant of permission to conduct clinical trial, Permission to conduct clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India, Permission to conduct clinical trial of a new drug already approved outside India, Conditions of permission for conduct of clinical trial, Validity period of permission to initiate a clinical trial, Post-trial access of investigational new drug or new drug, Academic clinical trial, Inspection of premises relating to clinical trial, Suspension or cancellation of permission to conduct clinical trial
  • · General principles, Systemic toxicity studies, Male fertility study, Female reproduction and developmental toxicity studies, Local toxicity: Dermal toxicity study, Photo-allergy or dermal photo-toxicity, Vaginal toxicity test., Rectal tolerance test, Parenteral drugs, Ocular toxicity studies, Inhalation toxicity studies, Allergenicity or Hypersensitivity, Genotoxicity, Carcinogenicity., Animal toxicity requirements for clinical trials and marketing of a new drug
  • Research Study Design: Experimental and Observational Study design
  • Introduction and History of Drug Discovery and Biomedical Ethic
  • Definitions and General Principles and Practices 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, Proceedings of Ethics Committee for clinical trial, Maintenance of records by Ethics Committee for clinical trial
  • • Compensation in case of injury or death in clinical trial, Medical Management in clinical trial, Consideration of injury or death or permanent disability to be related to 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 drug substances and formulations
  • Post market assessment and Data elements for reporting serious adverse events occurring in a clinical trial
  • Protocol for conducting clinical trials, Informed consent, Undertaking by the investigator, Investigator's brochure

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Dr. Kanav Khera
Professor

Working as Professor, Dept of Pharmacology/Pharmacy Practice, with more than 15 years of experience in Clinical Research/Biomedical Ethics/Evidence-based medicine, Antibiotic Stewardship program, pharmacovigilance, Drug Safety, Clinical trials, and outcome research. Dr Kanav Khera is also associate member secretory of 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 35 research papers in National and international journals and was invited as a guest speaker at various events.