You are currently browsing the PLS Clinical Research Blog weblog archives for the day 30. November 2009.
- Uncategorized (21)
- 22. March 2010: Informed Cosent
- 22. February 2010: Data Capture Methods
- 8. February 2010: Costs and finances in clinical trials
- 27. January 2010: Clinical Trials: Need and Ways
- 25. January 2010: PROJECT MANAGEMENT
- 17. January 2010: Pharmacovigilance :
- 17. January 2010: Adaptive Clinical Trials
- 11. January 2010: How ICH-GCP differs from Indian GCP?
- 25. December 2009: An exclusive workshop on fundamentals of ICH-GCP and clinical research
- 17. December 2009: Top 5 Mistakes of RFP
Archive for 30. November 2009
“Single-window” and e-governance
30. November 2009 by harshit.
The most recent initiative announced by the CDSCO is possibly one of the most exciting. The Ministry of Health and Family Welfare has agreed to invest close to INR250 Crore (around $50 million) in an e-governance initiative for the CDSCO to operate efficiently and transparently. Some of the e-governance initiatives contemplated include online submission of all forms, a digitalized interactive portal, digitalization of records and online approvals with digital sign. Currently, six Indian government departments have some role in approving certain aspects of drug regulations, a situation that leads to delays and a waste of resources. US-based technology solutions provider MGRM is developing a system to track and manage the complete drug regulation process. By 2013 companies are expected to be able to file and track applications online and access information concerning licensing, regulation, monitoring and even inspection audits13. Initiatives such as the central registry of volunteer fingerprints and another recently launched initiative of releasing on a daily basis, correspondence concerning drug and device companies would be accessible via the system. Internal to the CDSCO, the technology is expected smooth the interface between relevant government departments.
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