Diploma of 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.
Diploma of 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).
Continuing Education Certificates
2-3 Credits
Designed for working professionals and graduate students, PEARA’s Continuing Education Certificates provide focused, skill-based training in key regulatory affairs topics. These short-format courses are ideal for individuals seeking to expand their qualifications, explore new career pathways, or meet continuing education requirements in clinical research and pharmaceutical regulation.
Program Highlights:
• International regulatory frameworks covered: USA, Europe, and MENA Regions
• Certificate of Completion issued for each course
• Delivered online with live sessions, interactive case studies, and hands-on assignments
• Ideal for professionals in pharma, medical devices, quality assurance, and clinical trials
Course Tracks & Descriptions:
• Track 1: Regulatory Sciences & Compliance
• Course 1: Drug Life Cycle, GCP, GMP (USA, EU, MENA)
• Course 2: QA & QC Concepts (ICH & WHO-based)
• Course 3: Biologics & Biosimilar Submissions
• Course 4: Medical Device Regulation & Classifications
• Course 5: Cosmetics & Combination Product Regulations
• Course 6: Pharmacovigilance & Advertising Compliance
• Track 2: Clinical Research Operations & Leadership
• Course 1: Clinical Trial Fundamentals, Budgeting, Adverse Event Reporting
• Course 2: Role of Pharmacists in Clinical Trials & IP Management
• Course 3: Quality Assurance in Clinical Trials + CAPA Planning
• Course 4: Principal Investigator Roles & Trial Leadership
• Course 5: Clinical Data Management, Validation & Auditing