Regulatory Affairs Graduate College Credit Certificate
Innovation is rife in today's world, but there is a long path from concept to implementation.
Nearly every phase in the drug and medical devices’ lifecycle starting from R&D moving forward through clinical research to marketing is governed by regulations.
The development of new drugs, biologics, and medical devices is a long, complex, and expensive process. It is estimated that the development of a new drug can take up to 15 years and cost up to $2 billion dollars. So, the pharmaceutical industry is always under enormous pressure to reduce the time and cost to bring these products to the market.
The success of a pharmaceutical company depends increasingly on experts with experience in regulatory processes due to continuous updates in legislation, policies, as well as technologies.
When one considers the vast number of products regulated by the regulatory authorities, it is clear why professionals with expertise in Regulatory Affairs have perhaps never been more important.
You can work with a government organization to protect patients’ safety or assist companies in bringing compliant medical products to market—there are many options in the field of Regulatory Affairs.
What is Regulatory Affairs?
The science responsible for applying the standards and regulations that assess the safety, efficacy, quality, and performance of the regulated medical products in order to get regulatory authorities’ approvals. Regulatory affairs is the link and the “go-between” the pharmaceutical or medical device company AND the regulatory authority that regulate them like the U.S. Food and Drug Administration, European Medicines Agency, or any equivalent authority.
The biomedical industry needs regulatory affairs specialists to help engineers and scientists meet the regulatory authorities’ standards as they develop new drugs, medical devices, and biologics.
What Do Regulatory Affairs Specialists Do?
- Advise engineers, scientists or project teams about regulations and standards.
- Compliance with domestic or international regulatory agencies and inspectors.
- Prepare, gather, and review raw documents, including reports, international standards, harmonized guidelines, and clinical protocols.
- Prepare or review regulatory submissions.
Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – (USA & Europe): 14 Credit.
Program Description
This program tackles the regulatory processes in USA and Europe, providing a detailed knowledge that enables students of understanding the history, requirements, and process required for registration of Drugs and Medical Devices in the concerned regulatory authorities. Introducing drug’s lifecycle starting from clinical studies and ending by a finished product that enters the market, as well as, going through the medical device’s processes and comparing the requirements between both authorities.
Program Objective
A 14-hour credit program that is designed to create Regulatory Affairs professionals who have the know-how of regulatory processes and are able of dealing with the regulatory authorities in USA and Europe (USFDA and EMA respectively). To enrich the program and make it a unique experience for students, the curriculum includes a variety of learning methods such as critical thinking which helps in demonstrating the actual case for students.
Regulatory Affairs of Drugs and Medical Devices Graduate College Credit Certificate – (MENA Region): 5 Credit.
Program Description
A program that is tailored to deliver the knowledge that students need regarding the different authorities in the MENA region (Jordan, Saudi Arabian, and UAE). Interactive online classes help students understand the requirements better and enable them to go through examples that better describe the processes they will go through, and obstacles may face.
Program Objective
This 5- hour credit program aims to support Regulatory Affairs professionals in understanding all requirements and processes in the MENA region by explaining all steps needed for registration of drugs and medical devices there. Simplicity is the key in this program, as it covers all MENA authorities in a manner that enables students of having solid knowledge of the regulations, enables them of confidently submit applications and have them approved with the least deficiencies (if any).
Our Instructors
Maha Mobasher, CEO/Director of Education/Instructor:
- CEO of RADEX Institute in Florida-USA.
- 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 Chemistry, Generics and Molecular Medicine for pre-med students.
- MS/ PhD student in Pharmaceutical Sciences (Nova Southeastern University, Ft. Lauderdale, Florida).
- MS in Chemistry with a Minor in Business Administration (Seton Hall University, South Orange, NJ).
- MS In science and education (Kings College, London UK).
Asma Abu-Stiateh, School Director/Instructor:
- Director of RADEX Institute in Florida-USA.
- CEO/ Founder of “RADEX for Regulatory Affairs Consultation” office, Amman-Jordan.
- Master’s degree in Regulatory Affairs of Drugs, Biologics, and Medical Devices (Northeastern University, USA).
- Submission and registration of more than 50+ products ranging between drugs, biologic, biosimilars, medical devices, vitamins, herbal products, and cosmetics.
- Consultant for 10+ pharma companies in Jordan, Saudi Arabia, UAE, Europe, and USA.
- Founder and trainer of the first “Regulatory Affairs of Drugs and Medical Devices” diploma course in the Middle East, with many classes and hundreds of graduated students from twelve countries around the world including: Jordan, USA, Saudi Arabia, Dubai, Abu Dhabi, Sharjah, Ajman, and many others.
- Author of the first 3 Regulatory Affairs books in the Middle East named “Regulatory Affairs of Drugs and Medical Devices / USA and Europe”, “Regulatory Affairs of Drugs and Medical Devices / USA, Europe, And Jordan”, “Regulatory Affairs of Drugs and Medical Devices / MENA Region” with copy rights from both Jordan and Saudi Arabia.
- Owner of “PVEX pro” Pharmacovigilance System and its PV software, according to the EMA and ICH Guidelines, which can be used by any pharmaceutical company in any country.
Tuition Fees
Graduate College Credit Certificate – USA & Euroup
Application Fees
$100
Tuition Fees
$5,879
Graduate College Credit Certificate – MENA Region
Application Fees
$100
Tuition Fees
$2,362
* Ask more about our “Payment Plan”, we offer a MONTHLY payment installment option for both programs.