Gary Palgon | Liaison Technologies
A new model of aggregating, harmonizing and analyzing healthcare data is giving pharma companies unprecedented ability to both reduce development costs and to accelerate the time bringing new drugs to market.
Called dPaaS for Data Platform as a Service cloud-based model puts the focus on data being at the center of the business universe rather than applications. This means that regardless of what application is required, access to data is always available. More often than not today, we have applications that create boundaries around data rather than making data accessible for all business needs. Not only does dPaaS provide maximum flexibility and scale for pharma researchers, but it allows expert scientists to use their time and skills wisely toward actual drug development, rather than serving as high-cost “data janitors” in cleaning and preparing their data for analysis.
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In The Headlines
Ramon Chen | Reltio
Creating a compliant culture: In this age of distributed data sources, commercialization of IT with “bring your own devices,” the demands of business to get faster and unrestricted access to data, compliance teams are more challenged than ever before. The reality is that although the onus of compliance and regulatory reporting fall to the select few within the enterprise that bear that title, being knowledgeable about best practices in handling sensitive data, and doing business in a compliant way is everyone’s responsibility.
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Topic of Discussion
Priyabrata Sahoo | MetricStream Inc.
Keep an eye for the warning signs in your internal procedures and processes to reduce the risk of being caught by the FDA.
Oops! I got the FDA warning letter. Now what should I do? How should I respond to prevent further enforcement actions by the Agency? And all the other barrage of questions scares you. Look at it differently. How do you foresee that a warning letter is coming? What are the signs that can help you anticipate a letter from the Agency? If you can do that, then hopefully, you can take steps to avoid one and resolve it before FDA knocks your door.
Warning Letter Trends
In the recent past the FDA has made an effort to speed up the warning letter program. This means that they will no longer build an airtight legal case before issuing the letter. Multiple warning letters are also no longer being issued. In some cases, the FDA has shown that it will not even issue a formal letter before shutting down a facility, recalling products or revoking licenses.
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East Norriton, Penn. Feb. 4, 2016. TGaS® Advisors is expanding its roster of commercial solutions with the addition of Medical Regulatory Legal (MRL) Operations. The new solution reflects high client demand in this critical area. The benchmarking and advisory firm also named TGaS Management Advisor Karl Kraft to head the new practice. The MRL benchmark is in growing demand as companies seek to make this critical process shorter, more efficient, more strategic and less costly, according to ... [Continue Reading]