Regulatory FAQs for implementing a cGMP system from clinical trials to commercialization
Product development from molecule identification to regulatory approval can take on average 7 years. During this drug development cycle, a typical biotech company will have outsourced all if not a majority of their activities to Contract Service Providers like CROs or CDMOs. Given this complexity, and the global nature of the activities contracted, who is ultimately responsible for regulatory compliance?
In this on-demand webinar we will discuss how a phase-appropriate cGMP system can be implemented with increased levels of compliance as the molecule progresses through clinical trials to commercialization.
Complete the form below to listen to our webinar and receive an adjoining presentation deck on:
- An overview of the cGMP process and its importance in today’s climate.
- Establishing traceability in a cGMP process.
- How to interpret ambiguous cGMP guidelines and ensure compliance.
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.
K A Ajit-Simh
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.
Naresh Nayyar, Ph.D.
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.