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REGISTRATION IS OPEN LIVE VIRTUAL EVENT November 9—10, 2020

4th PQRI Workshop on ICH Q3D Elemental

Impurities Requirements

Key Speakers from FDA, USP and International Regulatory Authorities

Workshop Description

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 US 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.

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Registration is now open. Click here to register.

Please register for the workshop (even if you can’t attend it live); sessions will be recorded and made

available to registered attendees.

Pre-Workshop Events:

Please participate in our Pre-Workshop Survey. To complete the survey, click here.

FREE Workshop Preview Webinar on September 21, 2020. Click here to register for the webinar.

Questions? Contact the PQRI Secretariat at: PQRISecretariat@pqri.org.

Visit the PQRI Website for updates: https://pqri.org/4th-pqri-ei-workshop