As a majority of biotechnology and pharmaceutical companies operate on a "virtual" platform, reliance on Contract Service Providers (CSPs) has increased substantially. Identifying a CSP and using them to provide services in compliance to cGMPs requires the sponsor to adequately qualify their CSP to ensure sustained operating compliance.
In this on-demand webinar we will discuss how to select the optimal CSP for your long-term strategy from development to commercialization.
Senior Manager, Regulatory Affairs Clinical and Compliance Life Science Solutions, Thermo Fisher Scientific
Kasey has fifteen years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and regulatory compliance of instruments and consumables developed for automating cell and gene therapy manufacturing. Kasey holds a Bachelor's Degree in Medical Laboratory Science and postgraduate degrees in both Microbiology and Quality Systems Management.
President, Shiba Biotechnology Inc.
Aijt established Shiba Biotechnology Inc. in 1999 to provide regulatory compliance, quality strategy, and support to the biotechnology, pharmaceutical, and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted U.S. FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an adjunct professor and instructor at SDSU in regulatory affairs.
Vice President Regulatory Affairs, Turning Point Therapeutics
Naresh Nayyar, Ph.D. is an experienced regulatory affairs leader with broad experience in clinical/companion diagnostic/CMC and post-approval drug development activities. These include EU MAA, BLA, and sNDA approvals as well as multiple post-approval supplements. Currently he is Vice President of Regulatory Affairs at Turning Point Therapeutics. Naresh is experienced in preparing teams for regulatory agency meetings (pre-IND, Type B/C, EOP2, pre-NDA, and Clarification Meetings), managing interface with agencies, organizing regulatory agency meetings, preparing submissions, and negotiating and interacting with US and international regulatory agencies.