Access Consortium Releases Strategic Plan for 2021 – 2024
Access Consortium has released their Strategic Plan 2021-2024 in June 2021 to allow shareholders to learn more about the future …
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 …
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 …
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 …
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 …
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 …
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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