Regulatory Affairs Graduate College Credit Certificate
What Is RA Program Mission?
What Is RA Program Mission?
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?
What Is RA Program Mission?
What Is RA Program Mission?
- 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
Goals & Objectives
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.
Program Levels
Goals & Objectives
Goals & Objectives
- Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – Level 1 (USA & Europe): 14 Credit.
- Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – Level 2 (MENA Region): 5 Credit.
Graduate College Credit Certificate – Level 1 (USA & Euroup)
Program Description
This program is designed to assist the student with obtaining the necessary skills and knowledge to effectively navigate and manage regulatory affairs (RA) processes including operational RA, strategic RA, clinical RA, CMC RA, and submission specialist RA. The program includes critical thinking workshops and a project to allow students the opportunity to apply the theoretical knowledge in a practical way.
Program Objective
The objective of our Regulatory Affairs of Drugs and Medical Devices Graduate Certificate – Level 1 is to prepare students to apply their learned knowledge about USFDA and European regulations and regulatory affairs processes related to drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to bring a medical product to market.
Graduate College Credit Certificate – Level 2 (MENA Region)
Program Description
This program is designed to assist the student with obtaining the necessary skills and knowledge to effectively navigate and manage regulatory affairs (RA) processes including operational RA, strategic RA, clinical RA, CMC RA, and submission specialist RA. The program includes critical thinking workshops and a project to allow students the opportunity to apply the theoretical knowledge in a practical way.
Program Objective
The objective of our Regulatory Affairs of Drugs and Medical Devices Graduate Certificate – Level 2 is to prepare students to apply their learned knowledge about Jordanian, Saudi Arabian, and UAE (MENA Region) regulations and regulatory affairs processes related to drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to bring a medical product to market.
Special Requirment
* (Level 2 is Optional): Students who choose to enroll in level 2 in May, must first complete Level 1 before registering in level 2.
Level 1 (USA & Europe) Program
Level 1 (USA & Europe) Program
Level 1 (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
Level 2 (MENA Region) Program
Level 1 (USA & Europe) Program
Level 1 (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
Mrs. Asma Abu Staiteh
Director, Instructor
- Master’s degree in "Regulatory Affairs of Drugs, Biologics, and Medical Device", Northeastern University.
- Submission and registration of hundreds of products ranging between drugs, biologics, biosimilars, medical devices, vitamins, herbal products, and cosmetics.
- Consultant for 10+ pharma companies in Jordan, Saudi Arabia, UAE, Europe, and the USA.
- Founder and trainer of the first “Regulatory Affairs of Drugs and Medical Devices” training course in the Middle East, with students attending from 15 countries around the world including the USA, Jordan, Saudi Arabia, Dubai, Abu Dhabi, Sharjah, Ajman, and many others.
- Author of the first 3 Regulatory Affairs books in the Middle East with copyrights from USA, Jordan, and Saudi Arabia. named:
- Regulatory Affairs of Drugs and Medical Devices / USA & Europe.
- Regulatory Affairs of Drugs and Medical Devices / USA, Europe, & Jordan.
- Regulatory Affairs of Drugs and Medical Devices / USA, Europe, & MENA Region (Saudi Arabia, UAE, & Jordan).
- Owner and creator of “PVEX pro” Pharmacovigilance System and its PV software, according to the EMA and ICH Guidelines, that can be used by any pharmaceutical company in any country.
Dr. Maha Mobasher
CEO, Instructor
- Prepared the quality section for the FDA submission of many generic drugs.
- Eight (8) years of experience within the pharmaceutical industry and global pharmaceutical companies. Integrated specialty focused on developing, manufacturing, and distributing generic and brand products including: development, research, examination, quality control and assurance, prepared and conducted cGMP and SOP training sessions, provides scientific support to new product development, fill/finish tech transfer and manufacturing of parenteral products for external or internal manufacturers, and partnering with Technical Operations, Quality, Regulatory, and other functions to support flawless introduction of manufacturing processes into production sites
- Adjunct Professor at Broward Community College teaching Chemistry and Biochemistry for nursing majors.
- Adjunct Professor at Nova Southeastern University in the Science department teaching pharmaceutical sciences for pharmacy school and pre-med students.
