Introduction to the Master’s Class on US Pharmaceutical Regulatory Affairs Professional Certification Program
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WHEN
March 26, 2021 From 11:00 AM EST
Level
Moderate
Type
Complementary Webinar
Key Outcome
Essentials for Human Medicinal Products – EU and US Orphan Drug Application – EU and US Preparing Submissions in the Common Technical Document (CTD) Format Electronic Common Technical Document (eCTD) Registration of Drugs Based on Monoclonal Antibodies
Target Audience
Practice Managers Any Business Associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc) MD's and other Medical Professionals
Brief Description:
Introduction to 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. Courses that are included in this program are: 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
