Detailed Syllabus & Weekly Breakdown

Module 1: The AI & Digital Systems Landscape (Weeks 1–4)

• Week 1: Evolution of Systems: From legacy Safety Databases (Argus/ArisG) to "Next-Gen" Cloud-Native platforms; Understanding SaaS, PaaS, and AI-layers.
• Week 2: The Data Foundation: Big Data vs. Smart Data; Understanding how unstructured clinical data (doctor notes, lab reports) is digitized for AI consumption.
• Week 3: AI Logic vs. Clinical Logic: How Machine Learning (ML) identifies patterns vs. how a clinician evaluates a patient; Introduction to NLP (Natural Language Processing) in Pharma.
• Week 4: GenAI & LLM Foundations: Deep dive into Large Language Models; Understanding "Hallucinations" and why "Domain-Specific" AI is safer for Healthcare.

Module 2: Applied AI in the Value Chain (Weeks 5–8)

• Week 5: AI in Pharmacovigilance (PV): Automating ICSR intake; AI-assisted MedDRA coding; Using Agentic AI for 24/7 global literature surveillance.
• Week 6: AI in Clinical Trials: AI for patient recruitment matching; Predictive analytics for site performance; Automating Clinical Study Reports (CSR).
• Week 7: AI in Regulatory & Medical Writing: Using GenAI to draft PBRERs, DSURs, and Package Inserts; Automated translation for global dossiers.
• Week 8: Safety System Interoperability: How AI connects PV, Clinical, and Regulatory systems to create a "Single Source of Truth."

Module 3: Prompt Engineering, Ethics & Governance (Weeks 9–12)

• Week 9: Advanced Prompt Engineering: Mastering the "Chain-of-Thought" prompting for medical summaries; Creating "Personas" for regulatory analysis.
• Week 10: Governance & Validation: How to "Validate" an AI tool for GXP compliance; Understanding the "Human-in-the-loop" requirement.
• Week 11: Ethics & Bias: Identifying "Black Box" risks; Ensuring AI doesn't discriminate in clinical trial diversity or safety signaling.
• Week 12: Data Privacy & Security: Navigating HIPAA, GDPR, and Cyber-security in the age of AI; The role of Blockchain in securing patient data.

Learning Outcomes

• Strategic Evaluation: Identify exactly where AI can be injected into the PV or Clinical workflow to save time and reduce errors.
• Prompt Mastery: Expertly prompt AI tools to generate high-quality medical narratives, regulatory summaries, and data visualizations.
• Compliance Oversight: Oversee the implementation of digital tools while ensuring they meet FDA/EMA validation standards.
• Risk Mitigation: Audit AI outputs for hallucinations, bias, or privacy breaches in a clinical context.

Assessment Weightage

Assessment Type	Weightage
Module 1: AI Fundamentals Quiz	15%
Module 2: AI Use-Case Design	30%
Module 3: Medical Prompting Portfolio	30%
Final Capstone	25%