This course addresses the global aspects of drug development. In this highly interactive course participants will gain a better understanding of the overall drug development and regulatory processes by participating in a simulated drug development and review process. Presentations made by real-world functional area experts provide the groundwork for the IND and NDA Game simulations.
Ms. Finkle leads the Global Regulatory Consulting Services for Catalent, which provides comprehensive consulting services, developing and implementing solutions to enhance clients' performance in pharmaceutical and biotechnology research anddevelopment. Catalent has a team of experienced regulatory affairs professionals who can provide regulatory support at early and late stage product development, from Pre-IND FDA meeting support and IND/IMPD/CTA filings to Pre-NDA/BLA/MAA support and managing NDA/BLA/MAA submissions. Catalent's unique approach is a combination of strategic and tacticalconsulting and practical, hands-on implementation to improve the speed, efficiency and quality of the entire product development process.
Ms. Finkle has more than 25 years of scientific and industry experience including 15 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada. Before joining Catalent, Ms. Finkle worked with MedImmune/AZ, PAREXEL International, Celsion Corporation, TherImmune Research Corporation, GeminX Biotechnologies, ConjuChem and BioChem Pharma. She has received numerous awards and scholarships throughout her career and currently serves as a faculty member of the PERI and adhoc faculty for the University of California San Francisco (UCSF) American Course of Drug Development and Regulatory Sciences (ACDRS). Ms. Finkle has also co-authored one book chapter, more than 18 abstracts and 12 papers for industry associations and scientific publications.
For more information on this course and to register, please visit here.