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 will provide an overview of the compliance experience since the 2017 PQRI Workshop and will review ongoing work throughout industry to resolve challenges involved in global implementation of the Elemental Impurities (EI) guidelines and standards. Specific topics will include the following:
- Current State of Implementation of ICH Q3D Globally (Regulatory and Industry Experience)
- Pharmacopeia Approaches to Element Specific Requirements in Monographs (including Industry perspective and consequences)
- Ongoing ICH Q3D Activities
- Lhasa Database Update
- PQRI Phase 2 Collaborative Study - Results and Recommendations
- Implications on Risk Assessments
- Breakout Sessions to Address the Above Topics
This workshop will include global experts from ICH Q3D IWG, industry, regulatory authorities, pharmacopeias, and academia who are intimately involved in this area.
Registration will open in August via PQRI.
Pre-Workshop Survey to launch with registration in August.
FREE Workshop Preview Webinar to be held on September 21, 2020. [Registration to open soon.]
Questions? Contact the PQRI Secretariat at: PQRISecretariat@pqri.org.
Visit the PQRI Website for updates: https://pqri.org/4th-pqri-ei-workshop