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Combination product design and development, and the decision making surrounding these processes, is complex. Early collaborations between CDMO’s and their manufacturing partners is an effective means of managing this complexity. However, the best collaborations seek to develop a common understanding of program risks, technical risks, decision-making processes, who decision-makers are, a common language for the design and development, and a common vision for the program. These collaborations work to identify potential commercial manufacturing risks, and then address them during product development, to reduce overall risk during product launch. This effort maximizes the opportunity to successfully and efficiently manufacture combination products that are compliant with FDA 21 CFR, or other relevant regulatory standards, including 210/211 for drug handling. We will explore an effective collaborative model for combination design and development, and how we leverage this model to bring complex products, including combination products, to market in a timely manner, without sacrificing product quality.

In this webinar, attendees will learn about: Assessment of potential DDIs by in vitro studies Application of the FDA guidance to DDI study design, data interpretation and modelling Understanding of fundamental theories and development strategies of PBPK models Benefits and applications of PBPK models to preclinical drug development and design of first clinical trials

This webinar will give an introductory presentation on NMPA current status, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, China NMPA data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions on the differences between Fda gudid and China NMPA.

The second-ever gene therapy received US Food and Drug Administration (FDA) approval last Friday, giving hope to infants with a severe form of spinal muscular atrophy (SMA), a devastating genetic disorder that kills most infants by their second birthday.

The world’s first malaria vaccine will be tested in 360,000 children per year across three African countries over four years, thanks to an initiative launched by the World Health Organization (WHO).