Three Reasons to Adopt Unit-Level Traceability Now


Pharmaceutical manufacturers and packagers are sprinting to build out their serialization architectures to comply with the Drug Supply Chain and Safety Act (DSCSA) requirements. It’s a race some will finish before others, and one in which some might not reach the finish line at all.
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Variety is the Spice of… Compliance: Cooking up a Solid Regulatory Team


The rapidly changing, constantly evolving regulatory environment has taken the pharmaceutical industry away from the days when it was sufficient to have one person in an office somewhere who everyone knew as “the regulatory guy,” who could do the job with some regulation books, a spreadsheet and a mileage allowance.
 
The current landscape demands not only an expert, but a team of experts, each well-versed in specialized areas. It’s the understatement of the century to say it’s challenging to contend with a vast array of compliance subtleties in so many areas – stocking, storage, transport, destruction, security, handling and on down the long list of rules that apply to each one from multiple federal, state and local regulatory sources.
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Can Regulatory Requirements actually Unshackle Promotional Creativity among Marketers?


We’ve all heard this complaint from marketing professionals and their promotional agency partners: “How can we be creative with all these regulations?” So when I came upon a blog post titled “Boosting Creativity through Constraints” written by innovation expert Adam Richardson in his Harvard Business Review, I had to flag it.
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Compliance Due Diligence in an M&A Environment


In the pharmaceutical industry, mergers and acquisitions happen on a fairly frequent basis and as such, require due diligence across various business processes. While these mergers may have positive and negative effects on the industry as a whole, one of the most pressing issues is whether the compliance risk is raised as a result.
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They Ain’t Just Whistling Dixie: The Latest on Whistleblowing in America’s Drug Industry


The past three years have been tough on America’s drug industry. The entire chain of commerce from Manufacturer to wholesaler to pharmacy continues to defend accusations that their business dealings caused the federal and state governments to pay “false” claims at taxpayer expense.   Through a seemingly orchestrated campaign, the US Attorney General, the Office of Inspector General for HHS, and various state Attorneys General all tout the ongoing need for persons with knowledge of industry practices to “blow the whistle” on their employers. This campaign is impacting all levels of the drug industry and targeting an array of conduct.
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Recent Trends in Whistleblower Protection under Dodd–Frank


The enactment of the Dodd–Frank Act was intended to provide the SEC with an important weapon in its mission to seek and vigorously prosecute the commission of securities and other types of frauds domestically and overseas. By providing to whistleblowers monetary incentives ranging between 10 percent and 30 percent of fines assessed, the whistleblower program has gained an element of popularity—some would say notoriety—amongst would-be reporters of putative wrongdoing. Recent Federal Court decisions, however, have created significant roadblocks that could blunt the Dodd–Frank juggernaut.
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