Michelle M.’s Post

Today is the last day of World Drug Safety Congress Americas. Be sure to attend “Evolving REMS Landscape: Regulatory Updates and Compliance Challenges” featuring UBC’s Jim Shamp at 11:45 am. Click here to meet with us. https://hubs.li/Q02QCMGX0 #PatientsFirst #WorldDrugSafety #SafetyandRiskManagement #DrugSafety

Important to take into consideration in your inspection readiness efforts

FDA Remote Regulatory Assessments (RRAs) become a frequent type of performing documents reviews and interviewing the teams, therefore, it is important to understand the FDA expectations on which requests are obligatory, which scope of the RRA is applicable to domestic and foreign inspections and what consequences might follow after RRAs.

🌍 At the recent 19th International Conference of Drug Regulatory Authorities in India, the importance of global collaboration in strengthening regulatory systems was a key focus. US Pharmacopeia very own USAID-funded PQM+ Program Director Jude Nwokike and Senior Global Health Technical Program Director @Lawrence Evans led a workshop that not only fostered meaningful discussions but also highlighted the critical role of partnerships in enhancing local production of quality-assured medical products. Also attending USP India Senior Director Matruprasad P. 🔍 As we engage in these pivotal conversations, the need for scientific expertise in global public health has never been more apparent. This is where you come in! USP is seeking passionate individuals to join our Expert Volunteer community. By volunteering with us, you can extend your impact beyond the conference room, contributing to the development of standards that ensure the quality, safety, and benefit of medicines and foods. 🌐 Volunteering with USP provides a unique opportunity to work alongside other experts from around the globe to help set the standards that protect public health. Your expertise could be crucial in navigating complex regulatory landscapes and bringing safe, effective medical solutions to all corners of the world. 🤝 If you are attended the conference and have been inspired by the discussions on enhancing regulatory frameworks and ensuring the safety of medical products, consider applying to become a USP Expert Volunteer. Together, we can make a difference that resonates across global communities. 🔗 To learn more about how you can contribute to this vital work and apply, visit https://lnkd.in/eumte8Xv #USPVolunteers #GlobalHealth #PublicHealth #RegulatoryExcellence #ICDRA #PharmaStandards

The 19th International Conference of Drug Regulatory Authorities in India brought together regulatory authorities from WHO Member States to strengthen collaboration and develop international consensus on regulatory priorities. USAID-funded PQM+ Program Director Jude Nwokike and Senior Global Health Technical Program Director @Lawrence Evans served as moderators for a workshop on “Strengthening Regulatory Systems Through Partnerships and Sustainable Local Production of Quality Assured Medical Products.” PQM+ representatives were encouraged by the fruitful discussions and networking opportunities with NRAs from various countries and stakeholders who are interested to collaborate with the program. #HealthSystems

In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Patty (黃薏華) Hwang and Mingping Zhang provide updates and guidance on the recent global alignment of the CDE on viral clearance and the likelihood of these validation methods being accepted among other agencies (EMA, FDA, ICH). Learn more from our ex-FDA, EMA, and NMPA/CDE regulators about how this change could impact your platform validation approach. Like and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly newsletter! #Regulatory #Viral #ClinicalResearch

In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Patty (黃薏華) Hwang and Mingping Zhang provide updates and guidance on the recent global alignment of the CDE on viral clearance and the likelihood of these validation methods being accepted among other agencies (EMA, FDA, ICH). Learn more from our ex-FDA, EMA, and NMPA/CDE regulators about how this change could impact your platform validation approach. Like and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly newsletter! #Regulatory #Viral #ClinicalResearch

Great insights in this article from Rebecca Kimmelfield and Nathan Beaver on how both regulations and non-binding guidance documents from the FDA may evolve post-Chevron.

In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Patty (黃薏華) Hwang and Mingping Zhang provide updates and guidance on the recent global alignment of the CDE on viral clearance and the likelihood of these validation methods being accepted among other agencies (EMA, FDA, ICH). Learn more from our ex-FDA, EMA, and NMPA/CDE regulators about how this change could impact your platform validation approach. Like and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly newsletter! #Regulatory #Viral #ClinicalResearch

In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Patty (黃薏華) Hwang and Mingping Zhang provide updates and guidance on the recent global alignment of the CDE on viral clearance and the likelihood of these validation methods being accepted among other agencies (EMA, FDA, ICH). Learn more from our ex-FDA, EMA, and NMPA/CDE regulators about how this change could impact your platform validation approach. Like and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly newsletter! #Regulatory #Viral #ClinicalResearch