| For example, with the signing of the US FDA Amendment Act (Pres. Bush-Sept 2007), how many in India TODAY know that US FDA clinical trials data disclosure requirements HAVE ALREADY CHANGED .
Are you comfortable with the new FDA requirements for reporting clinical trial data about drugs, devices, and biologics For certain clinical trials, the data submission due date was December 2007... and penalties for noncompliance can be $10,000 per day. On September 27, 2007 the FDA Amendments Act of 2007 became law. A significant provision of the law requires submission of 37 data elements from "applicable" clinical trials. The initial data elements include descriptive information, recruitment information, location and contact information, and administrative data, all of which are required in your submission of clinical trial results to FDA.
IT IS THIS LACK OF US FDA regulatory know-how and in depth understanding of the US FDA compliance for clinical trials in India we wish to address.
Our mission is to bring US FDA smarts globally starting with India and China with world class, experienced talents and experts from the US pharmaceutical and regulatory industry to foreign shores where they are desperately needed.
We've set our GLOBAL standards high ---- we challenge the market to give us a try !
For now we are focusing on:
1. Offering Dr. Joshua Sharlin's 30 or more live audio conferences on various US FDA regulatory compliance, etc.
2. Providing FDA regulatory compliance training/certificate via our partnership with India 's leading clinical research training institute, i.e. ICRI (Institute for Clinical Research India )
ICRI will bundle 5 of our live audio conferences as part of their student enrollment offering.
For more on ICRI--please see --- www.icriindia.com.
ICRI will issue to their enrolled Clinical Data Management enrolled students (along with FDASmart) a Certificate in US FDA Regulatory Compliance program to be bundled with their Clinical Data Management courses. The certificate will be granted after students participate with a number of live audio conferences to be delivered by Dr. Sharlin from the US .
3. Live symposium and talks in India for Dr. Sharlin. These will one-two day talks targeted at Indian pharmaceutical, biotech, medical devices and CRO industry.
4. Local manufacturing GMP compliant audits and US FDA mock inspections in China or India REMOTELY MONITORED AND SUPERVISED by one of our by ex-FDA US GMP/CMC expert inspectors using the our exclusive SmartInspect system.
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