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Detailed Syllabus & Weekly Breakdown

Module 1: Clinical Research & Operations (Weeks 1–3)

Focus: The journey from Molecule to Human Data

• Clinical Trial Lifecycle: Deep dive into Phase I (Safety), II (Efficacy), III (Comparative), and IV (Post-marketing).
• GCP Deep Dive: ICH-GCP E6(R3) principles; Investigator responsibilities and Institutional Review Boards (IRB/IEC).
• Operational Stakeholders: Roles of the Sponsor, Clinical Research Organization (CRO), Site Management Organization (SMO), and the CRA/CRC.
• Trial Documentation: Protocol design, Informed Consent Forms (ICF), and the Investigator’s Brochure (IB).

Module Outcome: Demonstrate the ability to map a trial’s operational flow and identify the documentation required for ethical compliance.

Module 2: Pharmacovigilance & Patient Safety (Weeks 4–6)

Focus: Post-Market Surveillance and Risk Management

• Safety Reporting Foundations: Defining Adverse Events (AE), Serious Adverse Events (SAE), and Suspected Unexpected Serious Adverse Reactions (SUSAR).
• Case Processing: Individual Case Safety Reports (ICSR) intake, triage, medical coding (MedDRA), and narrative writing.
• Signal Detection: Understanding how "triggers" lead to safety investigations; The Risk-Benefit balance.
• Global Compliance: E2B(R3) reporting standards and the role of the QPPV.

Module Outcome: Competently triage a safety case and draft a basic medical narrative for regulatory reporting.

Module 3: Medical Devices & Materiovigilance (Weeks 7–9)

Focus: Engineering Compliance and Device Safety

• Classification Systems: Risk-based classification (Class I, IIa, IIb, III) under US FDA and EU MDR.
• Quality Standards: ISO 13485 (Medical Devices QMS) and ISO 14971 (Risk Management).
• Materiovigilance: Handling device malfunctions, User Errors, and Field Safety Corrective Actions (FSCA).
• Technical Documentation: The Summary of Safety and Clinical Performance (SSCP).

Module Outcome: Differentiate between drug and device regulations and classify a device based on its intended use and risk profile.

Module 4: Regulatory Affairs & Compliance (Weeks 10–12)

Focus: The "Gatekeeper" of Market Access

• Global Submission Pathways: NDA/ANDA (USA), MAA (Europe), and Import/Manufacturing Licenses (India/CDSCO).
• The eCTD Framework: Structure of the Common Technical Document (Modules 1–5).
• Health Authority Interactions: Responding to "Queries," managing inspections, and Post-Approval Changes (Variations).
• Ethics & GxP: Understanding the legal landscape of pharmaceutical marketing and data integrity.

Module Outcome: Navigate the eCTD structure and identify the correct regulatory pathway for generic vs. branded products.

Comprehensive Learning Outcomes

• Interdisciplinary Mastery: Explain how Clinical data flows into Regulatory dossiers and how PV monitoring continues for the device/drug's entire market life.
• Compliance Proficiency: Interpret and apply ICH-GCP, GVP, and ISO guidelines to real-world scenarios.
• Stakeholder Fluency: Speak the language of both technical scientists and corporate auditors.

Assessment Weightage

Assessment Type	Weightage	Focus Area
Modular Quizzes	30%	Weekly assessments to ensure conceptual clarity.
Regulatory Strategy Project	40%	A group project where students must design a "Go-to-Market" plan for a mock product, covering Clinical, PV, and Reg requirements.
Final Comprehensive Exam	30%	A proctored exam testing the end-to-end knowledge of the Life Science value chain.

The "WhiteCollar" Career Advantage

Most freshers are specialists in only one area, but recruiters at top CROs and Pharma companies prefer multi-domain literacy. This course ensures that if you are hired in PV, you already understand how your work affects the Regulatory team, making you a more efficient and promotable professional from Day 1.