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Global Regulatory Engagement
Focus Area: Global Regulatory Engagement
Items listed by newest to oldest in each category.
Proceedings, Publications, & Public Comments:
- Post-Submission Update: The Evolving Regulatory Landscape for Clinical Trials in India (Publication)
- The Evolving Regulatory Landscape for Clinical Trials in India (Publication)
- Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India (Publication)
- Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations (Public Comments)
- Indian Ministry Amends Informed Consent Rules (Publication)
- Comments to China FDA on resolving the backlog (Public Comments)
- Comments to China FDA on resolving the backlog, Chinese Translation (Public Comments)
- India’s Proposed Amendments to the Drug and Cosmetics Act (Publication)
- Drugs and Cosmetics Amendment Bill Comments and Recommendations (Public Comments)
- Clinical Trial Research is No Crime (Publication)
- CT Regulation in India: Science of Social Justice? (Publication)
- Clinical Trials, a Lost Opportunity for India (Publication)
- Comments to Draft Rules to Amend the Drugs and Cosmetics Rules (Public Comments)
- Implementation Roundtable: Follow Up on Regulatory Changes Relating to Clinical Trials in India (Proceedings)
- Multi-Regional Clinical Trials (MRCTs): Practice and Issues of Multi-Regional Clinical Trials’ Global Acceptance (Presentation – Login required)
- Webinar for India Regulatory Update (Presentation)
- India Regulatory Update, Causality and Compensation (Presentation)
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