Global Regulatory Affairs Hands-on Training Program with Project Work

Global Regulatory Affairs Hands-on Training Program with Project Work

Program Duration: 45 Days

Program Structure

Week 1-2: Introduction & Global Regulatory Frameworks

● Fundamentals of Regulatory Affairs

● Overview of global regulatory agencies (FDA, EMA, MHRA, TGA, CDSCO, PMDA)

● ICH guidelines and their importance

● Drug development lifecycle (Preclinical, Clinical, Post-market)

● Roles and responsibilities

Week 3: Regulatory Submissions & Documentation

● IND (Investigational New Drug) & NDA (New Drug Application) (FDA)

● MAA (Marketing Authorization Application) (EMA)

● ANDA (Abbreviated New Drug Application) for generics

● CMC (Chemistry, Manufacturing, and Controls) documentation

● Hands-on CTD/eCTD dossier preparation

Week 4: Clinical Trial Regulations & Compliance

● Clinical trial approval process (Global perspective)

● GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice)

● Ethical considerations and IRB/IEC submission

● Adverse event reporting & pharmacovigilance

● Hands-on: Preparing a clinical trial protocol

Week 5: Regulatory Strategy & Post-Market Requirements

● Labeling, advertising, and promotional regulations

● Post-marketing surveillance & pharmacovigilance

● Medical devices & combination product regulations

● Assignment: Create labels, brochures, and Instructions for Use (IFU)

Week 6: Know Your Documents

● Audit trail report, critical subcontractor quality agreement, and ISO certificate

● Risk management files and biological evaluation files

● Post-marketing surveillance files, PSUR, and PMCF files

● Document review

Week 7: Review of Documents

● Case study: Review documents and work with real-life clients and manufacturers (Full week)

Week 8: Project Preparation and Tool Training

● Submit projects for approval on tools and send query mail to manufacturers (Full week)

Final Week: Project & Certification

● Real-world case studies and regulatory strategy formulation

● Capstone Project: Students work on a regulatory submission dossier

● Mock regulatory agency review panel (students present their submissions)

● Final assessment & certification

Regulatory Submission Dossier Preparation & Review

Project Overview

The project provides hands-on experience in preparing and reviewing a regulatory submission dossier for a pharmaceutical or medical product Participants will simulate the regulatory approval process, applying knowledge gained throughout the course

Project Title

Regulatory Submission Dossier for Device Approval – A Real-World Simulation

Objective

Participants will work in teams (or individually) to prepare a regulatory submission dossier for a selected pharmaceutical, biologic, or medical device, following international regulatory guidelines (e.g., SFDA, EMA, CDSCO, PMDA, MHRA, TGA). The project will be evaluated through a mock regulatory agency review

Project Structure

Step 1: Product Selection & Regulatory Pathway Identification

● Choose a pharmaceutical drug, biologic, or medical device for submission

● Identify the appropriate regulatory agency (FDA, EMA, CDSCO, etc ) and submission pathway

Step 2: Preparing the Dossier

● Compile a regulatory dossier using the Common Technical Document (CTD) / eCTD format

Step 3: Submission & Mock Review

● Submit the dossier in CTD/eCTD format

● Conduct an internal peer review (teams will review and provide feedback on each other’s dossiers)

● Prepare a Regulatory Strategy Report outlining:

○ Justification for approval

○ Risk mitigation strategies

○ Post-marketing commitments

Step 4: Mock Regulatory Panel Review & Approval Decision

● Participants will present their submission in a mock regulatory panel review

● Panel (trainers & selected participants) will ask questions & challenge justifications

● Based on responses, dossiers will be approved, conditionally approved, or rejected, with feedback

Evaluation Criteria

● Completeness & accuracy of the CTD/eCTD dossier

● Clarity & justification in regulatory strategy

● Response to regulatory panel questions

● Team collaboration & presentation quality

Project Outcome & Certification

● Participants will receive a Regulatory Affairs Certification upon successful completion

● Outstanding projects may be featured as case studies for future training