The International Pharmaceutical Regulatory Affairs Professional Certification Program (PRA00A1)
(Certificate)
https://www.biopharmainstitute.com/LMS2018/badges/Regulatory Affairs
Includes the Following Individual Courses
Regulatory Affairs: Essentials for Human Medicinal Products (EU and US)
Orphan Drug Designation in the USA and Europe
Preparing Submissions in the Common Technical Document (CTD) format
Electronic Common Technical Document (eCTD)
Registration of Drugs Based on Monoclonal Antibodies
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
The European Centralized Procedure (CP)
The Mutual Recognition Procedure (MRP)
Variations to Marketing Authorizations in Europe
The Decentralised Procedure (DCP)