This integrated program covers the complete lifecycle of a drug—from clinical trials to market surveillance—alongside clinical data processing, healthcare billing documentation, and real-time electronic health record (EHR) management. Learning OutcomesUpon completing this program, participants will be able to:Apply GCP & Regulatory Standards: Interpret and implement ICH-GCP guidelines, trial protocols, and ethical principles during clinical trial execution and site monitoring. Process Drug Safety Cases: Accurately evaluate, code, and report adverse drug events (ADRs) using MedDRA terminologies and standard drug safety reporting software. Assign Accurate Medical Codes: Analyze patient clinical documentation and apply correct ICD-10-CM, CPT, and HCPCS codes following official compliance guidelines. Create Real-Time EHR Notes: Chart physician-patient encounters in EHR platforms using clinical notation (SOAP format) while maintaining medical vocabulary fluency.Ensure Regulatory & Patient Data Compliance: Maintain strict compliance with global guidelines (FDA, HIPAA, EMA, DCGI) regarding patient safety, data integrity, and privacy.
Course Details
Explore the comprehensive course modules
History of Clinical Research and Biomedical Ethics ICH Good Clinical Practice Basic Principles 2025 Guidelines ICMR 2017 Biomedical Ethica Guidelines and New Drug Clinical Trial Rule 2019 and 2023 Articifical Intelligence and Drug Discovery Various Phases of Clinical Trials and PMS
Role and Responsibility of IRB/IEC Role and Responsibility of Investigator and Sponsor Informed Consent Process Clinical Trials Feasibility Studies Clinical Trail Data Management
History of Clinical Research and Biomedical Ethics ICH Good Clinical Practice Basic Principles 2025 Guidelines ICMR 2017 Biomedical Ethica Guidelines and New Drug Clinical Trial Rule 2019 and 2023 Articifical Intelligence and Drug Discovery Various Phases of Clinical Trials and PMS
Role and Responsibility of IRB/IEC Role and Responsibility of Investigator and Sponsor Informed Consent Process Clinical Trials Feasibility Studies Clinical Trail Data Management
Introduction to Pharmacovigilance PVPI, MEDWATCH, AEFI overview MEDRA Coding Language ICH E2A Guidelines
Introduction to Medical Scribing Role and responsibility of Medical Scriber Electronic Health Record System Bilable Items Medical Terminology
Introduction to Medical Coding and Its Importance ICH11 Disease coding Language ATC-DDD Coding Language for Drugs HCPCS Coding Language CPT Coding Language
Clinical Research Case Studies Pharmacovigilance Case Studies Medical Coding and Scribing Case Studies
Introduction to Pharmacovigilance PVPI, MEDWATCH, AEFI overview MEDRA Coding Language ICH E2A Guidelines
Introduction to Medical Scribing Role and responsibility of Medical Scriber Electronic Health Record System Bilable Items Medical Terminology
Introduction to Medical Coding and Its Importance ICH11 Disease coding Language ATC-DDD Coding Language for Drugs HCPCS Coding Language CPT Coding Language
Clinical Research Case Studies Pharmacovigilance Case Studies Medical Coding and Scribing Case Studies
History of Clinical Research and Biomedical Ethics ICH Good Clinical Practice Basic Principles 2025 Guidelines ICMR 2017 Biomedical Ethica Guidelines and New Drug Clinical Trial Rule 2019 and 2023 Articifical Intelligence and Drug Discovery Various Phases of Clinical Trials and PMS
Role and Responsibility of IRB/IEC Role and Responsibility of Investigator and Sponsor Informed Consent Process Clinical Trials Feasibility Studies Clinical Trail Data Management
Introduction to Pharmacovigilance PVPI, MEDWATCH, AEFI overview MEDRA Coding Language ICH E2A Guidelines
Introduction to Medical Scribing Role and responsibility of Medical Scriber Electronic Health Record System Bilable Items Medical Terminology
Introduction to Medical Coding and Its Importance ICH11 Disease coding Language ATC-DDD Coding Language for Drugs HCPCS Coding Language CPT Coding Language
Clinical Research Case Studies Pharmacovigilance Case Studies Medical Coding and Scribing Case Studies
Learn from leading experts in stem cell research
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.
Report of NIRF Data Capturing System: Management Report of NIRF Data Capturing System: Pharmacy Report of NIRF Data Capturing System: Engineering Report of NIRF Data Capturing System: Overall Report of NIRF Data Capturing System: Law Report of NIRF Data Capturing System: Architecture Report of NIRF Data Capturing System: Innovation Report of NIRF Data Capturing System: Agriculture Report of SDG Institution Report of NIRF Data Capturing System: Management Report of NIRF Data Capturing System: Pharmacy Report of NIRF Data Capturing System: Engineering Report of NIRF Data Capturing System: Overall Report of NIRF Data Capturing System: Law Report of NIRF Data Capturing System: Architecture Report of NIRF Data Capturing System: Agriculture
