Globalization of Clinical Research Trials and Investigations
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan. The key challenges for the creation of global regulatory and clinical development plans are reviewed, along with a discussion of the essential components required to meet Good Clinical Practice (GCP) and regulatory expectations for the conduct of a global trial.
At a Glance
- Target Audience: This course is designed for regulatory and clinical professionals who have a basic understanding of clinical trial conduct in at least one major region and who are or may be participating on company teams planning for the global registration of a drug product.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Medical Device Certificate Elective
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Discuss challenges for multi-country clinical trial managements
- Define global regulatory strategy and explain how such a strategy may be applied to support multi-regional marketing applications
- Successfully prepare a clinical investigational plan for multi-country studies
- Explain the importance of early management and oversight of multinational clinical trials
- Describe the needs and elements of a global regulatory plan to navigate various country requirements and describe the processes of key agencies to review clinical trial applications
- Identify medical considerations for multinational trials and understand which procedures are relevant to various regions/countries
- Describe and prepare for logistical challenges, including various requirements for the registration of trials and transportation of clinical trial material and samples
Lesson Titles
- Lesson 1: The Importance and Challenges of Considering Multinational Trials
- Lesson 2: Clinical Investigation Plans
- Lesson 3: Management
- Lesson 4: Global Regulatory Plans
- Lesson 5: Medical
- Lesson 6: Logistical Issues
This course is also included in:
