Good Clinical Practice (GCP) and Regulatory Compliance

  • Tutor: R. Malle
  • Level: Beginner
  • Study time: 7.5 hours
  • Video time: 6.5 hours
  • Exams: 1
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WHAT'S INCLUDED ?

Overview of Good Clinical Practice

Delve into the core principles of GCP and their importance in clinical research.

Regulatory Frameworks and Compliance

Understand the regulatory landscape including FDA, EMA, and ICH guidelines.

Ethical Considerations in Clinical Trials

Learn about the ethical aspects of clinical trials and patient safety.

Documentation and Data Integrity

Explore best practices in documentation, data collection, and management.

Audit and Inspection Preparedness

Gain insights into preparing for audits and regulatory inspections.

Case Studies and Real-World Applications

Engage with practical examples and interactive case studies to apply your knowledge.

BENEFITS OF TAKING THIS COURSE.

Enhance Regulatory Knowledge

Elevate your understanding of global regulatory standards and compliance requirements.

Boost Career Prospects

Stand out in the clinical research field with specialized knowledge in GCP and regulatory compliance.

Improve Trial Management Skills

Acquire skills to manage clinical trials more effectively and ethically.

Preparation for Audits

Learn how to prepare for and successfully navigate regulatory audits and inspections.

Ensure Patient Safety

Enhance your ability to uphold the highest standards of patient safety in clinical trials.

Interactive Learning Experience

Benefit from an engaging, interactive learning environment with practical applications.

WHAT OUR STUDENTS SAY ABOUT THIS COURSE

Princess D.

Clinical Research Coordinator
     
As a clinical research coordinator, this course was a game-changer for me. The depth of knowledge I gained in GCP and regulatory compliance has immensely improved my confidence and efficiency at work. Highly recommend it

Jayshaun, S

Aspiring Clinical Research Professional
     
The course offered a perfect blend of theoretical knowledge and practical applications. The case studies were particularly insightful, providing a real-world perspective to complex regulatory scenarios.

Alice R.

 Junior Clinical Research Coordinator
     
If you're in clinical research, this course is a must! The comprehensive coverage of GCP guidelines and regulatory compliance has been pivotal in my professional growth. The instructors are knowledgeable and engaging, making complex topics accessible and interesting."

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Management of Subject Study Visits

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Preparing for Monitoring Visits

Get ready for CRA monitoring visits in clinical research! We'll help you prepare for success with essential steps to ensure a smooth visit. Let's dive in!
Created by

R. MALLE

With 10+ years of experience in various hospitals and pharmaceutical companies, Rudy has honed his expertise in multiple therapeutic areas and clinical trial phases. He has excelled in leadership roles, demonstrating a strong ability to train and guide teams effectively. His practical knowledge and commitment to excellence make him a key educator in the academy.
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