Women Leaders in Pharma’s Post

ARE YOU INTO SECURITY? WATCH THIS VIDEO!!! SERVICE BEYOND EXPECTATION FET & TAPA WORKING TOGETHER Securing the Future: Highlights from TAPA EMEA CONFERENCE FET 2024 #security #tapa #pharma #GDP #temperaturecontrolled #compliance #transport #clinical trials #healthcare #pharma

🚨 Important DSCSA comments from the #FDA at 2024 FDLI Annual Conference! 🚨 Dr. Patrizia Cavazzoni, Director of CDER at the FDA, made it clear: the deadline for November 2024 is set in stone. 📅 There will be no further extensions. "... come this November, there will be no more reprieves. “I really want to emphasize that this is not really a matter of kicking the can down the road.” Industry should use the one-year stabilization period to “troubleshoot and get assistance and secure their processes” so that all systems are ready by November 2024." Don’t wait until it’s too late! Contact LSPedia today to ensure you're #DSCSA compliant and fully operational by November 2024. 🔗 https://lnkd.in/g_D_H3rh #FDA #compliance #pharmaceuticals #regulation #LSPedia #pharmacy #DrugSupplyChainSecurityAct #healthcare #pharma

If you have been keeping up with the industry news, you have likely read about FDA’s firm standing on the DSCSA enforcement deadline. Patrizia Cavazzoni, Director of CDER US FDA, recently stated, “I really want to emphasize that this is not really a matter of kicking the can down the road.” She urges the industry to use the one-year stabilization period to “troubleshoot, get assistance, and secure their processes” so that all systems are ready by November 2024. Will your company be ready for the DSCSA? Do you know with whom you share information? Read more: https://lnkd.in/gseZCZ_S #Spherity #FDA #Pharma #SupplyChain #RegulatoryCompliance #DSCSA #Traceability

Trends to watch in the #HealthcareSupplyChain: 1) Ongoing drug shortages, 2) federal oversight and 3) the Drug Supply Chain Security Act. In this Supply Chain Dive article, HIDA SVP Linda O'Neill discusses HIDA's preparedness playbook (hida.org/playbook) as part of a broader effort of public-private coordination on supply chain issues.

After having had the opportunity to spend 2 days with industry peers, paired with lots of stimulating discussions, I am back home 😊 and thinking of the time I had in Toronto at the Pharmaceutical Compliance Canada Congress. 🌟 Standout aspects of the conference were certainly the second day, as we broke out into groups, and I had the opportunity to sit with those in the MedTech stream. We had a small group which led to great open discussions, kicking off with a session led by Raj Malik and Stephan Ekmekjian, where we dove into scenarios that came across the Medtech Canada desk. 💬 This was followed up by an insightful presentation by Jean-Raphael Champagne and Daniel Fabiano who discussed data privacy, and some of the key aspects that we should be thinking about in preparation of an instant response plan, namely the WHO (key stakeholders that need to be informed), the WHAT (data and departments that could be most impacted), and the HOW (the breach response plan). 🔍 This was paired with the fact that we should be working on data minimization as well as auditing our vendors to ensure that they too are prepared for a breach. ✅ Thanks to all for a great couple of days! 🙏 #PCCCanada #InformaConnectLifeSciences #pharmaceuticalcompliance #medtech #biopharma #compliance #abetterexperience

🚨 ‼️ Dear Valued Partners, ‼️ 🚨 As we approach the firm deadline for the Drug Supply Chain Security Act (DSCSA) in November 2024, it is imperative to highlight that there will be no further extensions. Adherence to these regulations is critical for continuing our operations and ensuring the integrity of the drug supply chain. At Landstar Drugs, we are fully compliant with all federal regulations and are prepared for the DSCSA requirements. Our commitment to compliance ensures that we maintain the highest standards of safety and efficacy in our distribution processes. For our partners in animal and human health sectors, it is crucial to ensure readiness for these changes. Please confirm that your systems are equipped with a GS1 Global Location Number (GLN) to meet the traceability requirements stipulated by the DSCSA. We appreciate your immediate attention to this matter and your continued cooperation in meeting these regulatory standards. #DSCSA #FDA #Pharmaceuticals #Farmacias

The US Food and Drug Administration (FDA) does not intend to further delay enforcement of requirements for manufacturers’ track and trace verification systems under the Drug Supply Chain Security Act (DSCSA) and expects those systems to be up and running this November, asserted Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research (CDER). It is time to run the final stretch and NOT about kicking the can down the road, it's about readiness and resilience! 💊 Get full details here: https://bit.ly/3wBGxz9 #FDA #DSCSA #supplychain #trackandtrace

There are several precautions regarding service partnerships with China mentioned in this article. However, one bright spot is partnerships via product commercialization in China. “China’s market continues to be attractive, and the majority of biopharmas wish to consider commercialization,” the report said. “Collaboration with Chinese service providers in clinical research, development and manufacturing is also not completely off the table, with approximately 30% of respondents considering these partnerships as likely in the next three years." #biosecureact #industryadjustments #biopharma #cdmo #cro #commercialization #research #outsourcing

The Global IDMP Working Group (GIDWG) has written a series of five articles for the DIA Global Forum. The GIDWG is an international group with a mission to conduct and report on projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and the maintenance of global identifiers. Founding members include EMA, the U.S. FDA, and WHO-UMC. Regulatory agency members include Brazil ANVISA, Health Canada, Saudi Food and Drug Authority (SFDA), Swissmedic, Norwegian Medical Products Agency, as well as the industry organization, IFPMA. When fully implemented globally, the standards will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications throughout the world. The first 3 articles were published in the May issue (https://lnkd.in/eRJstfrp) and now the last two additional articles in the series have published in the June issue. The focus of the June issue is: IDMP and Cross-Border Healthcare: Eliminating Language Barriers and Global IDMP Working Group: Focus on a Framework for Global Implementation (https://lnkd.in/enRBwew8) Look forward to seeing you at DIA San Diego. Come to the GIDWG session #319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data on June 18 at 10 am (https://sched.co/1Yg82).