The International Pharmaceutical Regulatory Affairs Professional Certification Program (PRA00A1)

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) 


ICH GCP training 11 October 2018

ICH GCP E6 Addendum (R2) training 15 June 2018

EU/GCP training 5 October 2017




The19th April 2018, I have passed the Board Exam for the BCMAS (Board Certified Medical Affairs Specialist) Program and I am registered Board Certified Medical Affairs Specialist (BCMAS).


The program includes the following 20 individual modules


Curriculum Overview (details)

The Pharmaceutical Industry

Medical Device Industry

Diagnostics Industry (IVD)

Rules Governing Interactions with Healthcare Professionals

Health Economics Outcomes Research (HEOR)

Evidence-Based Medicine (EBM)

Clinical Trial Designs

Presentation and Communication Skills

Regulatory Affairs


Abstract and Medical Writing

Publication Practices

Drug Development Process

Medical Information

Medical Science Liaisons and Field Based Medical Teams

Grant and Investigator-Initiated Study Funding and Process

Advisory Boards 

Phase IV/Post-Marketing Studies

Risk Evaluation and Mitigation Strategies (REMS)

Medication Safety and Pharmacovigilance 


Introduction to the Biology of Cancer by Johns Hopkins University on Coursera

License number: UDJEMJ4MZR2L