RAPS Spain Local Networking Group’s Post

𝐑𝐄𝐂 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐄𝐯𝐞𝐧𝐭: 𝐓𝐡𝐞 𝐍𝐞𝐰 𝐒𝐮𝐩𝐞𝐫𝐡𝐞𝐫𝐨 𝐨𝐧 𝐭𝐡𝐞 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 – 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐞𝐂𝐓𝐃 𝐯𝟒.𝟎? Register here: https://lnkd.in/es7V7BWs This Explorer Class is designed to provide you with a comprehensive understanding of the Electronic Common Technical Document (eCTD) v4.0 submission process. We will start by introducing the 5 key principles that will form the blueprint of your #eCTD v4.0 journey. You will learn how to identify and effectively manage the challenges in implementing a new standard and how to navigate the required activities sustainably. We will look at the expectations of the pharmaceutical industry and global health authorities. Our experts will provide you with a comprehensive understanding of the industry’s expectations and how you can leverage eCTD v4.0 to meet them. This Explorer Class is specifically designed for regulatory affairs professionals who want to stay ahead of the curve and gain the knowledge that can support your organizations compliance. This event is free for Regulatory Affairs Professionals Society (RAPS) members! Take advantage of your member benefits and gain RAC credit! #pharmaceuticals #medicines #regulatoryaffairs #regulatorycompliance

𝐑𝐄𝐂 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐄𝐯𝐞𝐧𝐭: 𝐓𝐡𝐞 𝐍𝐞𝐰 𝐒𝐮𝐩𝐞𝐫𝐡𝐞𝐫𝐨 𝐨𝐧 𝐭𝐡𝐞 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 – 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐞𝐂𝐓𝐃 𝐯𝟒.𝟎? Register here: https://lnkd.in/es7V7BWs This Explorer Class is designed to provide you with a comprehensive understanding of the Electronic Common Technical Document (eCTD) v4.0 submission process. We will start by introducing the 5 key principles that will form the blueprint of your #eCTD v4.0 journey. You will learn how to identify and effectively manage the challenges in implementing a new standard and how to navigate the required activities sustainably. We will look at the expectations of the pharmaceutical industry and global health authorities. Our experts will provide you with a comprehensive understanding of the industry’s expectations and how you can leverage eCTD v4.0 to meet them. This Explorer Class is specifically designed for regulatory affairs professionals who want to stay ahead of the curve and gain the knowledge that can support your organizations compliance. This event is free for Regulatory Affairs Professionals Society (RAPS) members! Take advantage of your member benefits and gain RAC credit! #pharmaceuticals #medicines #regulatoryaffairs #regulatorycompliance

𝐑𝐄𝐂 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐄𝐯𝐞𝐧𝐭: 𝐓𝐡𝐞 𝐍𝐞𝐰 𝐒𝐮𝐩𝐞𝐫𝐡𝐞𝐫𝐨 𝐨𝐧 𝐭𝐡𝐞 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 – 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐞𝐂𝐓𝐃 𝐯𝟒.𝟎? Register here: https://lnkd.in/es7V7BWs This Explorer Class is designed to provide you with a comprehensive understanding of the Electronic Common Technical Document (eCTD) v4.0 submission process. We will start by introducing the 5 key principles that will form the blueprint of your #eCTD v4.0 journey. You will learn how to identify and effectively manage the challenges in implementing a new standard and how to navigate the required activities sustainably. We will look at the expectations of the pharmaceutical industry and global health authorities. Our experts will provide you with a comprehensive understanding of the industry’s expectations and how you can leverage eCTD v4.0 to meet them. This Explorer Class is specifically designed for regulatory affairs professionals who want to stay ahead of the curve and gain the knowledge that can support your organizations compliance. This event is free for Regulatory Affairs Professionals Society (RAPS) members! Take advantage of your member benefits and gain RAC credit! #pharmaceuticals #medicines #regulatoryaffairs #regulatorycompliance

In this blog post, we will explore the top 10 things you need to know about eCTD 4.0 and its potential benefits for the industry.

As we conclude our 12-week blog series exploring the transition from eCTD 3.2.2 to eCTD 4.0, it's essential to reflect on the key considerations and potential benefits for sponsors. Read our final RegOps Radar post to learn more: https://hubs.ly/Q02JMrcG0 #RegOpsRadar #FDA #eCTDv4

Essential for anyone involved in container closure integrity testing at any stage in the product life cycle.

Here's a quick update on my recent and planned activities. Currently, I have a third patent application under review and have filed a new Provisional Patent Application that describes 10+ inventions related to the BLOS# test. Recently, I met with an FDA consultant to discuss a strategy for the FDA Regulatory Pathway for the BLOS# test. Additionally, I am working on an NIH STTR Proposal for the evaluation of the BLOS# test. Exciting times ahead! #patentapplication #FDA #NIH #BLOS#test

The recent example of counterfeit Ozempic, has many asking: Is DSCSA a failure? A better question: what can make DSCSA more effective right now? As always, these our thoughts that are open for further dialogue.... https://lnkd.in/gzGsQgwa

Scalable, cost efficient and time sensitive. These three pillars are why we created the Essential AAV & LVV offering. We’ve brought speed & rigor together to help deliver your GMP batch of vector in under 12 months on a scalable platform designed to support you through Phase I and beyond. Is Essential the right fit your advanced therapy needs? Learn more: https://hubs.ly/Q02wNWxf0

Was just helping a friend through some citations for review of their AVS (smoke studies). Seems like some companies are still viewing this as a "check box" exercise. They are missing the chance to unlock the power of these studies to make their sterile operations better, safer, cleaner and more compliant... If your company is in that group, come to the ISPE Aseptic Conference and hear Morgan Polan and I review the upcoming ISPE AVS Handbook. "AIRFLOW VISUALIZATION - using smoke to make things clearer" We'll include tips, tricks and guarantee to make your AVS better and more useful. https://lnkd.in/gMeiiHqD