ICH GCP E6 R2 Certification Course

1️⃣ Compliance with Global Regulatory Standards

In today’s clinical research landscape, regulatory authorities such as the FDA, EMA, MHRA, and DCGI have strengthened their compliance expectations. The ICH E6 (R2) guideline ensures that clinical trials meet international Good Clinical Practice (GCP) standards, reducing the risk of regulatory violations, protocol deviations, and potential trial failures. Obtaining this certification demonstrates your commitment to conducting research ethically and in compliance with global standards.

2️⃣ Increased Career Opportunities in Clinical Research

With the increasing demand for trained clinical research professionals, many pharmaceutical companies, CROs (Contract Research Organizations), and biotech firms require candidates with ICH-GCP certification. Having this certification on your resume significantly enhances your career prospects as a Clinical Research Associate (CRA), Clinical Trial Coordinator (CTC), Quality Assurance Specialist, or Investigator.

3️⃣ Mastery of Risk-Based Monitoring & Data Integrity

One of the key updates in E6 (R2) is the focus on Risk-Based Monitoring (RBM) and Data Integrity (ALCOA++ principles). These elements are now critical in clinical trials to improve data accuracy, minimize errors, and ensure compliance. By obtaining this certification, you gain expertise in applying these modern approaches to clinical trial conduct, making you a valuable asset to any research team.

4️⃣ Competitive Advantage in the Industry

Employers prefer candidates who have up-to-date knowledge of ICH guidelines and GCP compliance. This certification sets you apart from the competition, demonstrating your ability to handle protocol adherence, informed consent processes, safety reporting, and regulatory inspections. It not only validates your knowledge but also enhances your credibility as a professional in the field.

5️⃣ Essential for Audits and Inspections

Regulatory authorities conduct routine GCP inspections to ensure trial compliance. Having an in-depth understanding of ICH E6 (R2) regulations helps you prepare for audits, manage Essential Documents, and maintain a high standard of compliance, reducing the risk of warnings, rejections, or study delays.

6️⃣ Gateway to Advanced Clinical Research Roles

This certification is often a stepping stone to higher roles in clinical research, such as Clinical Project Manager, GCP Auditor, or Regulatory Affairs Specialist. Professionals with a strong foundation in GCP principles are more likely to be promoted to senior positions due to their ability to manage regulatory challenges effectively.

7️⃣ Contribution to Ethical & High-Quality Research

Beyond career benefits, this certification ensures that clinical trials uphold ethical principles and prioritize patient safety. By following GCP-compliant practices, professionals contribute to reliable, high-quality research, leading to faster drug approvals and better healthcare outcomes.

💡 If you’re looking to advance your career in clinical research, improve your knowledge of global regulations, and stay ahead in a competitive industry, this ICH E6 (R2) certification is a must-have!

🚀 Join Clino Learn Training and Placement Center (CTPC) today and take the next step in your clinical research journey!

📌 Course Overview

The ICH E6 (R2) Good Clinical Practice (GCP) course is designed for clinical research professionals, investigators, monitors, sponsors, and quality assurance personnel. It covers the latest E6 (R2) amendments that emphasize risk-based approaches, data integrity, and compliance in clinical trials.

✅ Learn from industry experts
✅ Video lessons + case studies
✅ Get ICH-GCP certification
✅ Boost your career in clinical research

1. Introduction to ICH-GCP and E6 (R2) Overview

2. Regulatory Framework and Key Principles

3. Roles & Responsibilities of Stakeholders

4. Informed Consent Process & Subject Safety

5. Risk-Based Monitoring & Quality Management

6. Essential Documentation & Data Integrity (ALCOA++)

7. Electronic Systems & Audit Trails

8. Protocol Deviations & Compliance Strategies

9. Case Studies & Industry Best Practices

10. Final Assessment & Certification

📌 Module 1: Introduction to ICH-GCP and E6 (R2)

🔹 Video Lesson: History & Evolution of GCP
🔹 Key Learning: Importance of compliance, ethical considerations

📌 Module 2: Regulatory Framework and Key Principles

🔹 Video Lesson: ICH Guidelines & FDA, EMA, MHRA Regulations
🔹 Key Learning: Impact of E6 (R2) updates on trial conduct

📌 Module 3: Roles & Responsibilities of Stakeholders

🔹 Video Lesson: Sponsor, Investigator, IRB, Monitor Responsibilities
🔹 Key Learning: How each role ensures GCP compliance

📌 Module 4: Informed Consent Process & Subject Safety

🔹 Video Lesson: Ethics in Clinical Research & ICF Process
🔹 Key Learning: Protecting human subjects in trials

📌 Module 5: Risk-Based Monitoring & Quality Management

🔹 Video Lesson: RBM Implementation & CAPA in Clinical Trials
🔹 Key Learning: Identifying and mitigating risks in research

📌 Module 6: Essential Documentation & Data Integrity (ALCOA++)

🔹 Video Lesson: Source Documentation & ALCOA++ Compliance
🔹 Key Learning: Ensuring accuracy, reliability, and integrity in trial data

📌 Module 7: Electronic Systems & Audit Trails

🔹 Video Lesson: eCRF, EDC, and Regulatory Requirements for Electronic Data
🔹 Key Learning: Managing electronic documentation and audit trails

📌 Module 8: Protocol Deviations & Compliance Strategies

🔹 Video Lesson: Common GCP Violations & How to Avoid Them
🔹 Key Learning: Handling deviations and maintaining compliance

📌 Module 9: Case Studies & Industry Best Practices

🔹 Video Lesson: Analysis of Recent FDA/EMA GCP Inspections
🔹 Key Learning: Real-world insights and lessons from past inspections

📌 Module 10: Final Assessment & Certification

🔹 Video Lesson: Exam Preparation & Certification Details
🔹 Key Learning: Recap of key concepts, mock tests, and certification details

📑 Recent Case Studies & Industry Insights

📌 FDA Warning Letter Analysis – Non-compliance with E6 (R2) principles
📌 ICH E6 R2 Inspection Findings – Key takeaways from regulatory audits
📌 Data Integrity Failures in Clinical Trials – Lessons from industry cases
📌 Impact of Risk-Based Monitoring on Study Success

✅ Practical & Interactive Learning – Video lessons + real-world case studies
✅ Taught by Industry Experts – Learn from professionals with 10+ years of experience
✅ 100% Job-Oriented Training – Boost your career in clinical research
✅ Certification Included – Get recognized for your expertise

🔗 Enroll Today & Get Certified in ICH-GCP!

✅ Course Fee: ₹ 2,999/-
✅ Mode: 100% Online, Self-Paced
✅ Access Duration: 3 Months
✅ Includes:

• Full access to all modules & video lessons

• Downloadable study materials & case studies

• Certification upon successful completion

• Flexible learning at your own pace

📢 Limited-Time Offer: Get 10% OFF if you enroll before [date].

🚀 Start Learning Anytime, Anywhere! Enroll now and boost your career in clinical research.