On November 9 – 10, 2020, PQRI hosted a LIVE VIRTUAL workshop 4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements.
The implementation of the ICH Q3D guideline went into full effect in the United States and Europe in 2018 for all products. The Q3D guideline has been applied to new drug applications in the United States and Europe since June 1, 2016. This workshop provided an overview of and update on implementation experiences since the 2017 PQRI Workshop and reviewed ongoing work in the industry to resolve challenges involved in the global implementation of Elemental Impurities (EI) guidelines and standards.
The workshop included global experts from ICH Q3D IWG, industry, regulatory authorities, pharmacopeias, and academia who are intimately involved in this area.
PRE-WORKSHP EVENTS:
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- FREE Workshop Preview Webinar: PQRI hosted a Workshop Preview webinar on September 21, 2020. Click the links below to view the webinar recording and PPT.
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WORKSHOP MATERIALS
The Final Workshop Program is available here: Program.
PRESENTATIONS
Click here to access presentations.
QUESTIONS?
Contact the PQRI Secretariat at: PQRISecretariat@pqri.org.