EBR Systems, Inc.’s Post

Pharma companies must refine their patent strategies amid legal and regulatory shifts, said experts at LSPN Fall North America. A panel of in-house counsel discussed recent court rulings like Amgen v Sanofi, lifecycle management, and trade secret protection. Read more insights from the session here: https://ow.ly/Tte650TOayQ #PatentStrategy #LegalInsights #TradeSecrets

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in our Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.

Thoughts on this? >> Bipartisan letter questions FDA's 'narrow' interpretation for priority review vouchers >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #pharmaceutical #healthcare #biotech

Join us next month at the Regulatory Affairs Professionals Society (RAPS) Convergence Conference! Purnima Krishnan and Brion Carroll (II) will be at Booth 549 to discuss specific challenges you're facing as a regulatory leader in life sciences. Plus, don’t miss our session focused on “Managing the Regulatory Digital Thread - How leading medical device companies elevate the management of regulatory information.” Register here: https://hubs.ly/Q02K-2TM0 #regulation #digitaltransformation

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in our Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in our Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.

I am super excited about this masterclass in FDA communication 👇👇 Not just because Michelle Lott, RAC, is speaking. Register now: https://lnkd.in/ermeJiDs She's going to cover: ✅ Q-submission Insights: Understand the FDA’s various Q-submission options, including Pre-submissions, 513(g) Request for Information, Breakthrough Device Designation (BDD), and Safer Technologies Program (STeP). ✅ Strategic Questions: Develop skills to formulate precise questions that yield essential feedback, thereby smoothing your regulatory journey. ✅ Submission Mastery: Learn to compile the necessary elements for various Q-submission types to increase the likelihood of a favorable review. ✅ Applied Learning: Learn to select the best submission type for your device and business objectives. Prioritize the feedback you need to move forward. #FDA #presub #510k #medicaldevices #regulatoryaffairs

The Emergo by UL team is at #RAPSConvergence 2024.   The conference has officially commenced, and our booth is open with the Opening Reception & Welcome in the Exhibit Hall.   Come visit us at booth #739.   We look forward to discussing global medical device regulatory compliance and the services we may be able to provide, including our Regulatory Affairs Management Suite (RAMS): Benjamin Grosse-Siestrup, Nicole Shepherd, MONICA ENGEL, Andrew Chesemore, Stephanie Griffin, Yong Sun, Linda Chatwin, Keeshan Williams, Ph.D, Harrison Emery, and Deepak Kaul.   We also host a session on Wednesday 18 September at 3:30p on one of our favorite topics: Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success.   #medtech #medicaldevices #lifesciences #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #regulatoryreliance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in our Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.