February, 2017

The Insights and Sources We Trust

Contributors to this compilation include HighPoint experts John Wollman, Ted Marsh, Jim Slubowski, and Chris McShanag.

When Will We Be Convinced eDetailing Works? Part 2: Principles for Producing Engaging Digital Content

This blog was co-authored by: Antonio Pesqueira, Manager Life Sciences; Antonio Pregueiro, VP Life Sciences Commercial Excellence EU; and Sara Carvalho, Senior Associate Consultant. A special thanks to all of them for their…

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21st Century Cures Act Enables Digital Healthcare Advances

Feedback on the passing of the 21st Century Cures Act in early December 2016 has generally been encouraging, with many industry experts weighing in on the positive impacts of the…

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Inspection Readiness Needs a Data-First Solution

In 2016, the U.S. Food and Drug Administration (FDA) published draft guidance on “Data Integrity and Compliance” with respect to Current Good Manufacturing Practice (CGMP). This Guidance was published in…

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Enhancing Patient Safety: IDMP & ICH E2b(R3) Synergy

Since 2010, European Union (EU) Pharmacovigilance legislation is subject to regular and further enhancements because of EudraVigilance (EV), particularly the collection, management, and analysis of suspected adverse reaction reports. This…

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Improving the Quality, Safety and Effectiveness of Mobile Health Applications

Hopefully not lost among all the headlines on the future of U.S. healthcare, an important collaboration was announced at the end of 2016, the launching of a new group that…

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340B: Guidance and Potential Implications

On January 30, 2017, the OMB website officially designated the 340 B Omnibus Guidance as withdrawn. Manufacturers should continue to follow historical guidance in place until the new administration provides…

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The Potential Impact of the eForm on Your Tender Database

As part of the actions linked to a single market strategy, eForm aims at facilitating the management of data in the European procurement process. This new European legislation would apply…

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