This online professional program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US (and EU). Courses that are included in this program are the following: Essentials for Human Medicinal Products; Orphan Drug Application; How to Gain Approval to Market Generic Drugs in the US; Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; Preparing Submissions in the Common Technical Document (CTD) Format; Electronic Common Technical Document (eCTD); The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and Registration of Drugs Based on Monoclonal Antibodies.
CPD Points: 17
CPD Certified Date: 31st May 2019
Approximate Course Length: 17 Hours
*For mutli-user access prices to this course, please contact us.