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About Us
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Scott Liebman and Sandra González Attended ACI’s Latin America Summit on Pharmaceutical & Medical Device Regulatory Compliance
The Westin Playa Bonita, Panama City
March 11-13, 2013
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Scott Liebman and Sandra González attended ACI’s America Summit on Pharmaceutical & Medical Device Regulatory Compliance in Panama City. The Summit is the premier program for pharmaceutical, biotech, and medical device manufacturers on reducing liability exposures when structuring and conducting clinical trials overseas. It covered the complete international regulatory landscape, including privacy considerations, mitigating FCPA violations, interacting with the FDA and international governments, and ensuring that marketing activities are done compliantly.
Discussion Topics Included:
- U.S. FDA regulations and how to prepare for a government inspection/audit
- Increased focus on training and monitoring of good clinical practices
- Handling, storage and administration of the drug in accordance with defined protocols
- FCPA’s expansive jurisdictional reach and what increased cooperation among international enforcement agencies means in Latin America
- The international privacy environment and strategies for cross-border data transfer
- Educating the sales team on a drug/device risk and making sure they understand these risks before going into the field
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