- TypeWebinar
- Location New York, United States
- Date 15-06-2021
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
Live Webinar: Masters Classes on US Pharmaceutical Regulatory Affairs Professional Certification Program When: Tuesday Jun 15, 2021 - 11:00 AM Duration: 8 Hours.
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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. 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.
Areas will be covered during the Session:
This course gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.
It describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area. The procedures for making an application are detailed, that includes the acquisition of protocol assistance and collection of supporting data. In Europe, the Centralized Procedure is now the mandatory method to gain authorization for marketing of orphan products.
Learn what is needed for the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document.
And Many more to be covered in the session.