Government and Regulatory Affairs; Global Public Policy; Nanotechnology and Nanomedicine; Pharmaceutical Quality
I am looking forward to speaking at DIA 2024 next week and interacting with the government and regulatory affairs community who will join me in California. I will be chairing two crucial sessions on significant topics: high-risk excipients and drug shortages. The workshop titled Quality in Focus: Diethylene and Ethylene Glycol Challenges on Tuesday, June 18 at 11:00 AM will delve into the critical aspects of FDA's guidance on DEG testing, including quality tools available from Pharmacopeias, including USP, for ensuring the quality of excipients. You can learn more about this topic in a recent piece I contributed to @The Medicine Maker: US Pharmacopeia Mission to Address DEG/EG Contamination https://lnkd.in/eWPk-Zkj The Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation will be on Wednesday, June 19 at 11:00 AM. We will discuss how the medicine supply chains are becoming increasingly complex, requiring innovative solutions to ensure the continuous supply of quality medicines. As a standard-setting organization, US Pharmacopeia supports this work by facilitating global information exchange and enabling manufacturers to focus on production while ensuring product quality, safety, and supply chain resiliency. If you want to learn more about the drug shortages issues, please check out USP's call to action and the USP Annual Drug Shortages Report at https://lnkd.in/ecu5rYM3 If you are attending DIA and have time to catch these sessions, I look forward to interacting with you. #DIA2024 #Pharma #DrugQuality #RegulatoryAffairs