Combination Products 2025

Hot off the presses! Our Combination Products 2025 program has just dropped! Check out the program below, & join us in May for the latest in Combination Product development, quality, & regulatory compliance. Hear from our outstanding roster of experts: ·???????Khaudeja Bano,?Global Head, VP Device Quality, Genentech ·???????Heather Guerin, PhD, PE,?Global Regulatory Director, Novartis? ·???????Karl Hoelper,?Director, CCL Healthcare ·???????Alie Jahangir, Ph.D. Jahangir,?Head of Quality, CP, Biogen ·???????James McCaw,?Assoc. Scientist, Merck ·???????Doug Mead,?Founder, CP Pathways ·???????Susan Neadle,?President, CP Consulting Svcs.? ·???????Jennifer Riter,?VP Analytical Svcs., Kindeva Drug Delivery ·???????Subhi Saadeh,?Sr. Manager, Gilead Sciences? ·???????Kinsuk Shah,?Sr. AD, CP, Boehringer Ingelheim ·???????Sasha S., Director,?Systems Engineering, Eli Lilly & Co. ·???????Stefanie Stark,?Head, Regulatory Affairs, Ypsomed AG ·???????Cindy Tritton,?Sr. Engineer, Biogen ·???????Chuck Ventura,?Founder, Ventura Solutions? ·???????Sara Waxberg McNew,?CSO, Design Science? ·???????Fubin Wu,?Co-founder, GessNet ·???????Rumi Young,?Dir. Regulatory Affairs, Novo Nordisk? ·???????Jianxiu Zhao,?Sr. Manager, Terumo Medical Solutions Interested in attending or exhibiting? Contact Kim to secure your space:?[email protected]. Hope to see everyone there! #PharmaEdEvents #CombinationProducts #RegulatoryCompliance

We are so excited for Combination Products 2025! Full program coming very soon—watch this space! Click the link below to learn more about our distinguished 2025 speakers: https://lnkd.in/gHfSiBnQ Register today at www.pharmaedresources.com! Pre-conference discount is ending soon! #CombinationProducts #DrugDelivery #PharmaEdEvents??#DrugDevelopment

I'm thrilled to announce that after many years, and countless hours from many dedicated individuals (Rumi Young Courtney Evans James Bertram Patricia Love, Kristina Lauritsen, Sarah Mollo Alan Stevens Porsche Sanders, MS Max Lerman, PhD and many more - there are too many to name!!), the Draft Guidance for Essential Drug Delivery Outputs is out! Let’s bid farewell to the perplexing term ‘Essential Performance Requirements/EPRs’ and embrace the clarity of EDDOs. It’s more than a mere regulatory guidance; it’s a transformative framework and process that heralds a new era in combination product development and regulatory alignment. I’m eager to delve into this and pave the way for more streamlined methods. Keep an eye out for further insights!? #DrugDelivery #EDDO #CombinationProducts #SuttonsCeek https://lnkd.in/e6RcK5Xi

The "EPR" draft guidance is publishing 7/1.?Moving away from the abbreviation "EPR" (Essential Performance Requirements), which has been the source of much confusion across the industry, the new draft guidance is titled "Essential Drug Delivery Outputs (EDDOs) for Devices Intended to Deliver Drugs and Biological Products." The guidance describes FDA recommendations on device design outputs that are essential for establishing and assessing drug delivery performance. Docket No, FDA-2024-D-2560 https://lnkd.in/eUQwVRZw #combinationproducts #EPRs #drugdeliverydesignpoutputs #EDDOs

?? Mark your calendars! The Extractables & Leachables Summit 2024 is coming to the West Coast on November 6-7! Join us for a repeat of our celebrated event, featuring all the highlights you loved with a few new elements, now closer to home. Registration opens today. Don't miss out on early bird specials! Visit our website to learn more ? https://lnkd.in/gti9QPCJ #extractables #leachables #medicaldevices #biologics #drugdelivery #regulatorycompliance #biocompatibility #conference