This 30-hour Foundation Skill Development Programme prepares students for the Medical Information Associate (MIA) role, covering the full scope of pharmacovigilance and medical information functions — from AE case intake, triage, and narrative writing to signal detection, aggregate safety reporting (PSUR/PBRER/DSUR), medical inquiry handling, literature evaluation, PQC coordination, and regulatory compliance (FDA, CDSCO, EMA, NDCT, ICH-GVP). Delivered through lectures, case-based discussion, and hands-on simulation, industry-ready skill gaps. Learning Outcome: Learners will be equipped to perform end-to-end AE case processing, respond compliantly to medical inquiries, and support regulatory documentation in an industry setting.
Course Details
Explore the comprehensive course modules
MIA job profile: scope, KPIs, stakeholders, global regulated-environment expectations Pharmacovigilance Introduction and Regulatory Framework PVPI and CDSCO Role and Responsibility in Drug Safety MEDWATCH and WHO-UMC Syatem Overview Identification, Documentation, Monitoring and assessment of Adverse drug reaction
Casusality and Severity assessment of ADR: Case Study ICSR Reporting and Documentation MEDRA Coding Language: Adverse drug Reaction PSUR EDURAVIGIANCE AND Pharmacovigilance Planning
Learning Patient Case Profile and SOAP Analysis Medical Terminology Medication adherence and Patient Councelling techniques Medical Information Query and Literature search strategy and evidence-hierarchy based critical evaluation
Introduction To Evidance based medicine Drug Information database: Micromedex Software Demo Diabetes Pharmacotherapeutics : An EBM Approach Diabetes Pharmacotherapeutics : An EBM Approach Diabetes SOAP analysis
Introduction to EHR and Drug and disease Medical Coding languages ICH11 Disease coding Language and ATC-DDD Coding Language for Drugs HCPCS and CPT Coding Language Product Quality Compaints and Handling Case Studies
Medical information Case Studies Drug Safety Case Studies Coding 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
