skilldevelopment.cpe@lpu.co.in

What you'll learn

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

  • 1. Basic Principles of ICH-GCP 2. Role and responsibility of various stakeholders like IEC/IRB/Investigator/Sponsor/Regulatory bodies
  • 1. Biomedical Ethics: Basic Principles 2. Informed Consent Process and Vulnerable Groups 3. Protocol development 4. Equator guidelines for Protocol development
  • 1. Clinical Trials: Latest Indian Regulatory Guidelines for Conducting Clinical Trials 2. Regulatory Forms documentation and Submissions 3. Clinical Trial Registry of India (CTRI Submissions) 4. Clinical Trials Research Study Design 5. Clinical Trials Start-up Activities
  • 1. Introduction to Pharmacovigilance and Regulatory Framework (PVPI) 2. ADR Identification/Documentation/Causality Assessment 3. PSUR/ICSR report preparation and documentation 4. MEDRA Coding Language 5. VIGIFLOW and VIGIBase Pharmacovigilance software 6. Global ADR system (MedWatch USA, Upsala Monitoring system, EUDRA Vigilance, etc)
  • 1. Introduction to Clinical Trials, Basic Definitions. 2. Historical Events linked with clinical trials and Biomedical ethics 3. Overview of ICH framework with special focus on ICH Efficacy guidelines 4. Clinical Trials Phases and Drug Discovery Pipeline 5. Clinical trials: pipelines, molecules, and Industry Overview
  • 1. Medical Coding Languages (ICD-11, ATC-DDD, MEDRA etc) 2. Electronic health record and digital health record 3. Data Mining and Its Application in Clinical Research 4. Pathbreaking Artificial Intelligence case studies like DeepMind Technologies, application of quantum computers, and agentic AI in Clinical Trials, and drug safety 5. 2023 ICMR Artificial Intelligence Bioethics guidelines for Human research

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Dr. Kanav Khera
Professor

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