GCP: An Introduction to Clinical Trials in India
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It may have been updated or discontinued.
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This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline: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. | Objectives: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. | |
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