Duration: 2 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: GCP: An Introduction to Clinical Trials in India
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. India has been identified as an increasingly attractive country for conducting clinical trials and providing data management services. With its large patient population, well-trained investigators and considerably lower trial costs than in developed nations, India has gained wide recognition as a country capable of offering opportunities for conducting clinical trials. India's rapidly evolving regulatory environment based on the fundamentals outlined by the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (GCP) further enhances India's reputation as a suitable location to conduct global clinical trials. This online course details the aspects of culture, custom and practice in India which investigators must understand in order to consider clinical trials in the country.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The GCP: An Introduction to Clinical Trials in India course is found in the following professional certification program(s):
Overview: This session briefly describes the legislative instruments that apply to the conduct of clinical trials in India.
Background to India: This session outlines the Indian environment and the factors that make India suitable for conducting clinical trials.
Indian clinical development sector: This session provides a review of the opportunities for conducting clinical trials in India. At the end of this session, you will be able to evaluate factors to be considered before conducting clinical trials in India.
Regulatory landscape: This session discusses the framework of regulations that must be complied with to conduct clinical trials in India of medicinal products intended for US and EU markets.
Potential concerns: This session examines the concerns of global companies about conducting clinical trials in India.
Addressing concerns: This session examines the strategies India has adopted to overcome global pharmaceutical companies' concerns.
Case study: CROs This session provides you with the opportunity to put your knowledge of how to conduct clinical trials in India to the test. You will be addressing important points to consider when selecting and working with a Contract Research Organization (CRO). How can you ensure potential problems are adequately managed?
Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.
Students completing this course should be able to: Outline the factors that make India suitable for conducting clinical trials. Recognize the global pharmaceutical sponsors' concerns about conducting clinical trials in India. Review the opportunities and challenges for conducting clinical trials in India. Evaluate cost-effectiveness provided by clinical trials in India. Discuss the regulatory requirements which must be complied with when conducting clinical trials in India in order to license medicinal products in the EU and USA.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.