Preannouncement of Name Change of AHWP to GHWP

Asian Harmonization Working Party in short (AHWP) will be changing its name to Global Harmonization Working Party (GHWP). This change …

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World Health Organization first bio-similar pre-qualification

WHO (World Health Organization), pre qualified their first bio-similar. This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is …

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World Health Organisation Latest Guideline on Data Integrity

World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of …

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Transformation Of Digital Health for Regulatory Professionals

November 2019 saw a large focus on the changing digital health landscape alongside big data so what does this mean …

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IMDRF released 3 documents on clinical evaluations, clinical investigations and clinical evidence for medical devices

International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical …

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ICH guidelines Q12, E9(R1) and M9 adopted following assembly in Singapore

International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step …

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