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?
What Do Regulatory Affairs Specialists Do?
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.
- 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).
- 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.