HighPoint Blog

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

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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 input on this piece. 

Digitalization is spreading at a remarkable pace. But in the life sciences, leveraging digital alternatives to enrich customer engagement has a long...

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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 act and the need to continually advance new healthcare technologies.

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In 2016, the U.S. Food and Drug Administration (FDA) published draft guidance on “Data Integrity and Compliance” with respect to Current Good Manufacturing Practice (CGMP).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 response to a recent string of violations. In 2016 alone, FDA CGMP Warning Letters increased from 41 (in 2013) to 102. That’s a 148% increase in warning letters served.

 More than 45% of the...

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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 includes the implementation and use of new ISO Individual Case Safety Report (ICSR)/ICH E2B(R3) standards, which deliver better data structures including...

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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 is committed to improving mobile healthcare applications.

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On January 30, 2017, the OMB website officially designated the 340 B Omnibus Guidance as withdrawn.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 further clarity.

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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 to Life Science tenders as well. The increased importance of tendering  . The updates will potentially impact all the different types of tender existing within the European Framework. To fill some of the gaps...

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