Regulatory Affairs Graduate College Credit Certificate
What Is RA Program Mission?
RADEX Institute mission is to prepare both fresh science graduates and regulatory affairs experienced individuals to become competent professionals in the regulatory affairs processes, regulations, and submissions.
Why Choose RA Program?
- Cover all fields of regulatory affairs comprising of operational RA, strategic RA, clinical RA, CMC RA, Submission Specialist RA, and regulatory compliance.
- Critical thinking workshops that allow the trainees to apply the theoretical knowledge in a practical way.
- Hands on project that expose the trainees to real life experience.
Goals & Objectives
- Our goal is to educate students on USFDA, European, and MENA region (Jordan, Saudi Arabia, and UAE) regulations and regulatory affairs processes. Our objectives are to prepare students with the required skills to apply their learned knowledge to bring drugs, medical devices, and cosmetics into national and international markets.
Programs
- Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – (USA & Europe): 14 Credit.
- Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – (MENA Region): 5 Credit.
Regulatory Affairs - USA & Europe Program
Regulatory Affairs - USA & Europe Program
Regulatory Affairs - USA & Europe Program
RAD01C1 – Course 1:
- Drug Life Cycle.
- Clinical Trials and Good Clinical Practice (GCP), USA and Europe.
- Quality Assurance (QA) and Quality Control (QC) Regulatory Concepts.
- Good Manufacturing Practice (GMP) According ICH and WHO.
RAD01C2 - Course 2:
- Drug Regulations and Regulatory Submissions.
- Biologic and Biosimilar Regulations and Regulatory Submissions.
RAD01C3 - Course 3:
- Medical Device Regulations and Regulatory Submissions.
RAD01C4 - Course 4:
- Cosmetic Regulations and Regulatory Submissions.
- Combination Products Regulations and Regulatory Submissions.
- Advertising and Promotion Regulatory Framework.
- Pharmacovigilance Regulations and Regulatory Submissions.
RAD01C5 – Course 5:
- Practical Project
Regulatory Affairs - MENA Region Program
Regulatory Affairs - USA & Europe Program
Regulatory Affairs - USA & Europe Program
RAD02C1 – Course 1:
- Clinical Trials and Good Clinical Practice (GCP).
- Good Manufacturing Practice (GMP).
- Drug Regulations and Regulatory Submissions.
- Biologic and Biosimilar Regulations and Regulatory Submissions.
RAD02C2 - Course 2:
- Medical Device Regulations and Regulatory Submissions.
- Cosmetic Regulations and Regulatory Submissions.
- Combination Products Regulations and Regulatory Submissions.
- Advertising and Promotion Regulatory Framework.
- Pharmacovigilance Regulations and Regulatory Submissions.
RAD02C3 – Course 3:
- Practical Project