Clinical Research & Pharmacovigilance Notes M. Pharma 2nd sem

🔒 Secure access only – Notes are non-downloadable and cannot be saved in internal storage.

This course provides a complete understanding of clinical research methodologies and pharmacovigilance practices essential for ensuring drug safety and efficacy. It focuses on clinical trial phases, regulatory guidelines, ethical considerations, and global standards along with adverse drug reaction (ADR) reporting, risk assessment, and signal detection in pharmacovigilance.

The notes are clear, detailed, and exam-focused, enriched with flowcharts, diagrams, and tabular summaries for quick learning and revision.

✨ Key Highlights

• Full coverage of Clinical Research and Pharmacovigilance syllabus.

• Phases of clinical trials, study designs, GCP guidelines, and regulatory aspects.

• Pharmacovigilance systems – ADR reporting, causality assessment, signal detection, and risk-benefit analysis.

• Ethical and legal considerations in clinical studies.

• Flowcharts, diagrams, and structured notes for easy recall.

• Ideal for university exams, GPAT/NIPER prep, and research career pathways.

• 🔒 Secure access only – Notes are non-downloadable and cannot be saved in internal storage.

  This course provides a complete understanding of clinical research methodologies and pharmacovigilance practices essential for ensuring drug safety and efficacy. It focuses on clinical trial phases, regulatory guidelines, ethical considerations, and global standards along with adverse drug reaction (ADR) reporting, risk assessment, and signal detection in pharmacovigilance.

  The notes are clear, detailed, and exam-focused, enriched with flowcharts, diagrams, and tabular summaries for quick learning and revision.

  ---

  ✨ Key Highlights

• Full coverage of Clinical Research and Pharmacovigilance syllabus.

• Phases of clinical trials, study designs, GCP guidelines, and regulatory aspects.

• Pharmacovigilance systems – ADR reporting, causality assessment, signal detection, and risk-benefit analysis.

• Ethical and legal considerations in clinical studies.

• Flowcharts, diagrams, and structured notes for easy recall.

• Ideal for university exams, GPAT/NIPER prep, and research career pathways.