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Legal / Regulatory

Opioid crisis commission issues interim report with numerous calls to action

Clinical Operations
Legal / Regulatory

FDA struggles to react to ‘right to try’ laws

FEATURES

A conversation with Bijay Singh, DKSH

As multinational pharma companies look to expand their business globally, one of the attractive markets is Southeast Asia—essentially, the region between India and China. This region is modernizing rapidly: the middle class is on track to double to nearly 400

Blockchain: the technology to make DSCSA work after 2023?

Not withstanding FDA’s June 30 announcement that it was delaying enforcement of the Drug Supply Chain Security Act’s next phase by one year (November 2017 to November 2018), the global pharma industry will have invested several billion dollars in hardware

Pharma’s cold chain is going below zero

There is true excitement in the rapid pace of advances in cellular and genetic therapies—Kite Pharma, for example, one of the leaders in developing this science, has gone from concept to Phase III trials in 27 months, and an FDA

Digital factory transformation beyond serialization compliance

“Serialization” is like a new blockbuster drug for supply chains that is used in the “treatment” of counterfeiting or falsifications, while also helping with the quality and integrity of supply chains. Truly a game changer. It is already in the

Digital opinion leaders (DOLs) and their role in pharma markets

We suggest that in today’s increasingly digital media environment, with social media and other forms of online communication exerting influence equal to (or greater than) traditional media, digital communicators are rising in importance. From this, it follows that the “digital

2017 Product Security Report

Pharmaceutical Commerce has used the term ‘Year Zero’ in talking about 2017 and the deadlines for compliance with the US Drug Supply Chain Security Act, simply because the key next step—having a unique serial number on each package of product […]

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Clinical Operations

Clinical operations are heading for a unified digital platform, but how fast?