Preparation, Requirements and Submission of 505(b) (2) Regulatory Application with Case reports
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Instructor Profile
Jukka Karjalainen is a senior business executive, medical and scientific officer with extensive healthcare and industry experience spanning multiple medical specialties, Jukka is currently the President of pharmaceutical consulting firm that provides expertise for biotechnology and health sciences. Jukka brings to his clients a wealth of clinical research and pharmaceutical industry experience in the US, Canada and Europe.Jukka's professional roles have included 17 years in medical practice, and 25 years in biotech and pharma industry in medical and regulatory affairs, business development, private placement financing, M&A, and pharmaceutical and medical device development covering CMC, preclinical, regulatory and clinical drug development from Phase I to Phase IV. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why should Attend Attend this webinar to learn about 505(b) (2) regulations, process, benefits, concerns, and markets. Over the years specialized techniques have become available to "repurpose" or "reposition" the drug, to improve the drug substance or formulation, or revise or add therapeutic indications. INDs for 505(b)(2) products rely heavily on the information available about the reference product.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives The objectives of the presentation are to deal with areas including product development and regulatory filing strategies focusing on 505(b)(2) pathway.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit Sponsors of INDs Regulatory Affairs Professionals Drug Discovery and Development Professionals (R&D and CMC) IP Experts Clinical and Preclinical Laboratory Managers Project Managers and Clinical Trial Specialists Regulatory Compliance Associates and Managers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
How this Webinar Works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Track this link :
505 (b) (2) Regulations
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