ZÁZNAM | Proběhlo St, 17.2.2021
Případová studie ilustrující, jak překonat technické problémy léčivého přípravku pro vzácná onemocnění, který získal průlomový status FDA, a zároveň zajistit rychlé vývoj a v požadovaném čase.Přejít na webinář
A Scientific Journey of a Niche API Achieving Breakthrough Status by the FDA for a Lifesaving Drug for Infants
C&EN: A Scientific Journey of a Niche API Achieving Breakthrough Status by the FDA for a Lifesaving Drug for Infants
We will take a deep dive into the program, with a focus on:
- Optimization of the synthetic process
- Physicochemical characterization of the API molecule
- Analytical controls and specifications development
- Technology transfer to manufacture
- Process performance qualification (i.e. process validation)
- Establishing a phase and product-appropriate regulatory concept and dossier
Presenter: Bahareh Khalili, Ph.D. (Sr. Group Leader, Solid State & Process Analytical R&D, Eurofins CDMO Alphora Inc.)
Presenter: Petar Duspara, Ph.D. (Senior Group Leader, Research and Development, Eurofins CDMO Alphora Inc.)
Presenter: Yan Rodriguez-Evora, Ph.D. (Senior Team Leader, Analytical Services, Eurofins CDMO Alphora Inc.)
Presenter: Graham McGowan, Ph.D. (CMC and Regulatory Sciences Group Leader, Eurofins CDMO Alphora Inc.)
Presenter: Jeff Huber (Contributing Editor, C&EN Media Group)
