On November 9 – 10, 2020, PQRI will host a LIVE VIRTUAL workshop, the 4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements. This workshop will provide an overview of and update on implementation experiences since the 2017 PQRI Workshop and will review ongoing work in the industry to resolve challenges involved in the global implementation of Elemental Impurities (EI) guidelines and standards.
Not Available on November 9 – 10th? No problem. The entire Workshop will be recorded and available for anyone who registers for 30 days after the live event.
There is a FREE, Pre-Workshop Preview: 4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements, on Monday, September 21, 2020 from 10:00 – 11:00 AM US ET. The webinar will provide a unique opportunity to preview the Workshop topics.
David Schoneker, President/Owner, Black Diamond Regulatory Consulting, LLC
Douglas Muse, Compendial Affairs Liaison, Eli Lilly and Company
Donna Seibert, Ph.D., Senior Manager, Perrigo Company
James Harrington, Ph.D., Research Chemist, RTI International
Webinar Program and Abstracts:
I. Introduction and Overview of PQRI and the PQRI EI Workshop
· Moderator: David Schoneker
II. Current State of Implementation of ICH Q3D Globally
· Speaker: Douglas Muse
This presentation will preview the Workshop topics to be discussed during Day 1 (November 9th) and the morning of Day 2 (November 10th) including the results of the PQRI Pre-Workshop survey; the current state of implementation of ICH Q3D globally (IPEC Japan and China, Europe and US FDA regulator perspectives); Industry experience with implementation problems; Pharmacopeia approaches to element specific monographs (USP, PhEur and industry perspectives); update on recent ICH Q3D activities; update on the Lhasa Database; and a breakout session to address the above topics.
III. PQRI Phase 2 Elemental Impurities Collaborative Study Results and Impact on Industry and Regulators
· Donna Seibert, Ph.D. and James Harrington, Ph.D.
This presentation will preview Day 2 of the Workshop (November 10th): a comprehensive review of the PQRI Phase 2 Elemental Impurities study and a breakout session to explore the implications of the study for industry and regulators.
IV. Moderated Q&A Session with the speakers
Click the following link for the Speaker Bios.
Anyone interested in Elemental Impurities can also fill out the Pre-Workshop Survey (even if you can’t participate in the webinar or workshop) so your point of view can be represented in the PQRI survey results. The survey can be accessed HERE
Refer to the Workshop website to register for the Workshop and review the current Workshop program.