HighPoint Blog

Badr Fathi, Manager R&D Europe

Badr Fathi is a results-driven and persistent, problem solving, Life Sciences R&D consultant with a proven record of success in Regulatory Affairs, Clinical Development and Compliance projects. Being a subject matter expert within Clinical and Regulatory Affairs, Badr is also responsible for the growth and development of the HighPoint Solutions European Life Sciences R&D practice from a delivery perspective.
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Recent Posts

Latest revision of ICH guideline updates required data elements for transmission of Individual Case Safety Reports (ICSRs)

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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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“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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