Biosimilars webinar presented by Catalent expert for the pharmaceutical education and research institute
Posted: 1 May 2012 | | No comments yet
Carolyn Finkle at Catalent to present webinar…
Carolyn Finkle, Vice President, Global Regulatory Consulting at Catalent Pharma Solutions will present a webinar on “Biosimilars: Current Regulatory Environment and Development and Manufacturing Considerations” for the Pharmaceutical Education and Research Institute (PERI) on Thursday, May 3, 2012 from 12:00 to 1:00 pm EDT.
This webinar will explore the current regulatory environment and scientific challenges facing industry engaged in developing biosimilars with special emphasis on recent US guidance and the existing EU regulatory framework.
For more information on the webinar and to register, please visit https://netforum.avectra.com/eweb/DynamicPage.aspx?Site=PERI&WebCode=EventDetail&&evt_key=1de429e2-fad3-4f7a-bcfc-21463887c1c3
Ms. Finkle leads the Regulatory Consulting Services globally for Catalent, which provides comprehensive consulting services, developing and implementing solutions to enhance clients’ performance in pharmaceutical and biotechnology research and development. 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 filing to Pre-NDA/BLA support and managing NDA/BLA/MAA submissions. Catalent’s unique approach is a combination of strategic and tactical consulting and practical, hands-on implementation to improve the speed, efficiency and quality of the entire product development process. In addition to its global regulatory consulting offerings, Catalent is uniquely positioned to work with biopharmaceutical companies to develop and bring biosimilar products to global markets with its proprietary GPEx® technology and other services.
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 US 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 ad hoc 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.