Understanding India: How to Succeed With Clinical Trials
Product Details
That’s no accident. A clinical trial registry has been launched in India, and the government looks favorably on international clinical trials. Better infrastructure, an improved regulatory environment and a growing number of experienced researchers have caught the attention of sponsors looking to reduce drug development timelines and costs.
However, just like many other markets, a number of complexities still exist. Specifics in the regulatory guidelines, combined with regional and cultural intricacies, make it crucial to do your homework first.
In this 90-minute Encore presentation, international clinical research experts Dan McDonald and Vijai Kumar detail India’s regulatory environment today and where it’s headed. Plus they’ll explain how to submit studies to regulatory bodies either with or without third party assistance.
Sign up your entire team to listen in and discover:
- The structure and make-up of government regulatory bodies
- How to submit a study for regulatory review and approval, including necessary forms
- The types of studies currently allowed in India
- The intricacies of drug import and export licensing
- The structure and meeting schedules of institutional review boards
- The expectations of regulatory authorities
This audioconference examines specific details regarding the regulatory guidelines that exist today and where regulations are going. Plus, it covers specific case studies including success stories and potential pitfalls.