Course 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

Date: March 19
Duration: 30 minutes
Time: 1 PM EST

Learn highlights of the following:

• Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
• Regulatory Affairs: Orphan Drug Application – EU and US
• Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
• Regulatory Affairs: Electronic Common Technical Document (eCTD)
• Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
• Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US
• Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
• Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA