Radhika Ravi | Wipro
Today’s market demand is for Oncloud Hosting, Mobility and Integration which calls in for an application development framework with Business Processes, technology, Infrastructure, Regulations and the Security in built.” The Elephant” regulations and risk of Noncompliance is a trepidation and pervasive throughout.
Taming of the elephant has been in practice in the East form 200 BCE. In India, Elephants were not only in warfare but also domesticated and employed in Agriculture. Is not elephant raring and domestication a high risk? How was the animal domesticated? The answer is the beast was trained and habituated to work in synchronization on known pervasive risks factors about the animal.
Continue reading "Pervasive Risks Based Validated Application Development – Taming the Elephant"
In The Headlines
Diane Palmquist | GT Nexus
Pharmaceutical manufacturers walk a fine line balancing contradictory forces. They must think about new regulations versus increased outsourcing and expiring patents versus the expectation of sustained profitability, for example.
The bad news is that the rules imposed on the industry aren’t getting less complicated. And while it may keep compliance officers busy, regulations are just one of many forces eating away at manufacturers’ bottom lines. As brands go off-patent, pharmaceutical companies lose the luxury of high margins and are faced with fierce competition. As a result, they are forced to increasingly rely on outsourced active pharmaceutical ingredients (API) and expand into emerging markets to maintain and grow their revenue. That increased reliance on outside manufacturers, however, represents a loss of control – a concept which seems to run counter to tightening regulation. Movement into emerging represents another series of complications and challenges, including cost to serve new segments, security and traceability.
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Topic of Discussion
Joanna Belbey | Actiance
Based on my conversations with clients, there is a strong desire by middle management to comply with rules and regulations within the pharmaceutical industry. Middle level marketing, legal and compliance professionals worry about security breaches, identity theft and leaking patient information. As a result, they often hold their firms back from adopting new technologies and forms of communications, such as social media, for fear of being out of compliance.
Continue reading "Does Big Pharma Take Compliance Seriously?"