On November 9-10, 2016, PQRI hosted a public Workshop: PQRI/USP Workshop on Implementation Status of ICH Q3D Elemental Impurities Requirements – Analytical and Risk Assessment Challenges
The implementation of the ICH Q3D guideline is underway. The Q3D guideline will be applied to new drug applications in the United States and Europe starting on June 1, 2016. This workshop provided an overview of the first five (5) months of compliance experience and reviewed ongoing work throughout industry to resolve challenges involved in global implementation of the Elemental Impurities (EI) guidelines and standards.
Specific topics included the following:
- Regulatory Filing Observations for New Drugs – Industry and Regulator Perspectives
- Analytical Testing Considerations
- Data Sharing and Collaborative Studies – Key Learnings and Ongoing Efforts
- Risk Assessment Approaches that Work
- Preparing for Existing Drug Product Implementation in January 2018
- Benchmarking and Sharing Experiences Throughout Industry
This workshop included global experts from ICH Q3D IWG, industry, regulatory authorities, pharmacopeias, and academia who are intimately involved in this area.
The final program is now available here.
USP Meeting Center
12601 Twinbrook Parkway
Rockville, MD 20852
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.