E2B (R3) ICSR SUBMISSIONS & REGULATORY COMPLIANCE - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Drug Safety
 
Duration:
3 Weeks / 80 Hours
 
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E2B (R3) ICSR Submissions & Regulatory Compliance

Introduction – E2B (R3) Submissions

As global pharmacovigilance evolves, the electronic submission of Individual Case Safety Reports (ICSRs) has become mandatory for sponsors, CROs, and regulatory authorities. The ICH E2B (R3) standard defines how safety data must be structured, transmitted, and validated electronically to ensure harmonized reporting worldwide.

The E2BC program provides learners with a detailed understanding of E2B (R3) ICSR submissions, the regulatory framework that governs them, and the technical and compliance requirements for working in safety operations. It is essential training for professionals involved in case processing, regulatory submissions, and PV compliance.

Course Name :  E2B (R3) ICSR Submissions & Regulatory Compliance
Course Code :  E2BC
Experience Level :  Mid-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, or related sciences
Student Category :  Drug Safety Associates, PV Specialists, Regulatory Affairs Professionals, Clinical Data Managers

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (presentations, readings, practice quizzes, and simulated case processing exercises).
Key Learning Objectives

   By the end of this course, learners will:

  1. Understand the ICH E2B (R3) guidelines for electronic ICSR reporting.
  2. Learn the structure and data fields of E2B (R3) submissions.
  3. Differentiate between E2B (R2) and E2B (R3) standards.
  4. Explore the global regulatory requirements for ICSR submission (FDA, EMA, PMDA, Health Canada, MHRA).
  5. Gain knowledge of EudraVigilance, FDA FAERS, and other national submission gateways.
  6. Understand XML schema, data mapping, and validation rules in safety systems.
  7. Review the workflow of preparing, validating, transmitting, and acknowledging ICSRs.
  8. Examine compliance issues, audit findings, and CAPA strategies related to ICSR submissions.
Who Should Take This Course
  1. Drug Safety / PV Associates transitioning to regulatory submission roles.
  2. Regulatory Affairs professionals overseeing safety reporting.
  3. Clinical Data Managers handling structured safety data.
  4. Quality & Compliance specialists ensuring submission accuracy.
  5. Career changers with technical or life science backgrounds entering PV compliance.
Benefits & Outcomes
  1. Gain hands-on understanding of ICSR submissions under E2B (R3).
  2. Improve job readiness for regulatory submission and PV compliance roles.
  3. Learn how to avoid common validation errors in electronic reporting.
  4. Build confidence for audit and inspection scenarios.
  5. Position yourself for advanced PV/compliance roles such as ICSR Submission Specialist, Regulatory PV Coordinator, or PV Compliance Manager.
Career Pathways: After completing this course
  1. ICSR Submission Specialist
  2. Pharmacovigilance Compliance Associate
  3. Regulatory Affairs Coordinator (Safety)
  4. Safety Database Specialist
  5. EudraVigilance / FAERS Reporting Analyst

Curriculum & Modules

Modules
1. Introduction to ICSR Submissions in Pharmacovigilance

2. ICH E2B (R3) Overview – Purpose, Scope, and Benefits

3. Data Elements & Structure of E2B (R3) Messages

4. Key Differences Between E2B (R2) and E2B (R3)

5. Global Health Authority Requirements (FDA, EMA, PMDA, Health Canada, MHRA)

6. Overview of Submission Gateways – EudraVigilance, FDA FAERS, etc.

7. Data Mapping & XML Schema Basics for Safety Databases

8. Validation, Transmission, and Acknowledgment Process

9. Common Errors in Submissions & Regulatory Case Studies

10. Compliance Monitoring, CAPA, and Inspection Readiness

11. Practical Scenarios – Preparing and Reviewing E2B (R3) Submissions
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.