HighPoint Blog

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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“Medical products should meet standards of quality, safety and efficacy. The quality of medical products is, however, a major public health concern to the World Health organization and its Member States... The illegitimate manufacture, distribution, widespread availability and indiscriminate use of substandard/spurious/falsely labelled/falsified/counterfeit medical products have serious...

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With the expansion of IDMP scope, we need to make sure we are tracking new and evolving requirements and guidelines for substances. Industrywide, that’s our next target.

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Time to relax or time to do more work?

Q4 2018 may seem far, far away, but there is still lot to prepare for between now and then.

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Written by HighPoint Solutions R&D Practice

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