RiverArk Limited’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

I'll be speaking next Wednesday on a panel with 3 experienced PV and Regulatory global colleagues at the World Drug Safety Congress Europe in Amsterdam. Excited to discuss "Global oversight for diverging regulations and business partners: harmonizing stakeholders." Hope to see you there! #DrugSafety #RegulatoryCompliance #GlobalPharma #PanelDiscussion #Networking #WDSC

🗣️ A packed room for "𝐒𝐢𝐠𝐧𝐚𝐥 𝐫𝐞𝐟𝐢𝐧𝐞𝐦𝐞𝐧𝐭 𝐮𝐬𝐢𝐧𝐠 𝐑𝐖𝐃" – a day 1 presentation from #WorldDrugSafety's 𝘈𝘐 & 𝘔𝘢𝘤𝘩𝘪𝘯𝘦 𝘓𝘦𝘢𝘳𝘯𝘪𝘯𝘨 track with Jeffrey Brown, Chief Scientific Officer, TriNetX! Real-world data (RWD) is essential in pharmacovigilance (PV), providing a rich source of insights into drug safety and patient outcomes beyond clinical trials. This talk explored how RWD can be effectively harnessed in PV processes, improving signal detection and safety monitoring. Jeff notes that as we enter an era of AI-driven innovation, it’s crucial to recognize that AI’s success depends heavily on the quality, quantity, and diversity of the data it processes. ✅💡🙌 Get your ticket to be a part of the world's #1 drug safety event here: https://lnkd.in/gqpN6izz

We are pleased to share some exciting news from Synergen Bio. We are thrilled to announce that we have successfully undergone a highly challenging EMA inspection from April 16th to April 20th, 2024,conducted by two regulatory authorities simultaneously: The Federal Institute for Drugs and Medical Devices (BfArM) and the Danish Medicines Agency (DKMA). It was a comprehensive inspection comprising multiple studies and involving 4 inspectors. The scope encompassed full studies, and scrutiny extended to the inspection of CRO systems as well. This endeavour presented a significant challenge, rigorously testing both our team and our systems. This achievement serves as a testament to the unwavering dedication and seamless teamwork demonstrated within our organization. Our commitment to conducting studies with the utmost ethical standards and strict adherence to compliance for all major regulatory requirements remains steadfast. We express our sincere gratitude to our sponsors for their unwavering trust and collaboration. It's their confidence in our capabilities that drives our relentless pursuit of excellence. Learn more about us at www.synergenbio.com #QualityAssurance #BABE #Audit #DataIntegrity #ClinicalResearch

This Sunday, March 24, is 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗱𝘃𝗲𝗿𝘀𝗲 𝗗𝗿𝘂𝗴 𝗘𝘃𝗲𝗻𝘁 𝗔𝘄𝗮𝗿𝗲𝗻𝗲𝘀𝘀 𝗗𝗮𝘆, and the World Drug Safety Congress Americas team is proud to show our commitment and support in raising awareness about adverse drug events (A.D.E.). ❤️🩹 We recognize the importance of this holiday initiated by our Partner, the American Society of Pharmacovigilance, and learning more about the complicated topic of #adversedrugeffects to better understand their effects on humans and society. With this, we can best find solutions while lowering the possible cases of A.D.E. According to the Agency for Healthcare Research and Quality (A.H.R.Q.), A.D.E. is the “number one most costly and number one most preventable hospital-acquired condition.” Join the collective endeavor to raise awareness for #NationalAdverseDrugEvent and meet the faces of the American Society of Pharmacovigilance taking the #WorldDrugSafety stage this October in Boston: ⭐️ Benjamin Brown, Executive Director, American Society of Pharmacovigilance ⭐️ Sara Rogers, President, American Society of Pharmacovigilance 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝘁𝗼 𝗷𝗼𝗶𝗻 𝘁𝗵𝗲 𝗯𝗶𝗴𝗴𝗲𝘀𝘁 𝗻𝗮𝗺𝗲𝘀 𝗶𝗻 𝗱𝗿𝘂𝗴 𝘀𝗮𝗳𝗲𝘁𝘆 𝘁𝗵𝗶𝘀 𝗳𝗮𝗹𝗹: https://lnkd.in/gFzSXQf9 𝗣𝗵𝗮𝗿𝗺𝗮 𝗮𝗻𝗱 𝗯𝗶𝗼𝘁𝗲𝗰𝗵𝘀 𝗮𝗽𝗽𝗹𝘆 𝗳𝗼𝗿 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗺𝗲𝗻𝘁𝗮𝗿𝘆 𝗽𝗮𝘀𝘀 𝗵𝗲𝗿𝗲: https://lnkd.in/gFzSXQf9

We're thrilled to reveal that Berna Kosekaya, Regulatory Professional at Novo Nordisk will be joining us at the Injectable Drug Delivery conference in May to discuss 'Notified body opinion considerations for post-authorization changes' In this presentation Berna will provide insight into: - What constitutes a non-substantial change? - What is the threshold for requiring an updated Notified Body Opinion? - What are the main challenges? View the full agenda and speaker line-up here > https://ow.ly/Go2850QTfQ7

For those interested, the Live Broadcast of today's FDA ODAC meeting where #Carvykti and #Abecma will be discussed can be seen with the link below.

By investing in Drug Safety, it is possible to utilize the important knowledge inherent in the department and turn it into a business accelerator. ''The drug safety department is not just a crucial knowledge center, but also a catalyst for positive change. In industries where the quality of life is at play, our collective efforts can make a profound difference in ensuring the safety and well-being of patients worldwide'', says Ingelise Bærentzen Melchiorsen, Head of Drug Safety at NNIT. Read more in the blog article ➡ https://okt.to/zPAV9t

📣 Dive into the latest insights on Drug Safety! 🌐 Explore the compelling articles in Volume 47, Issue 5, May 2024. 📚 Elevate your knowledge and stay at the forefront of drug safety advancements. Check it out now: https://lnkd.in/exsvezc3 🔍 #DrugSafety #MedicalResearch 🚀