Complementary Webinar

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

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