Training and Programs
1 - Regulatory Affairs of Drugs and Medical Devices Professional Training Programs Certificate – (USA, Europe, & GCC): 165 Training Hours – 26 Weeks
Program Description
This program addresses regulatory processes in the USA, Europe, Saudi Arabia, and United Arab Emirates (UAE), providing students with in-depth knowledge to understand the history, requirements, and procedures for registering a wide spectrum of regulations and processes with relevant regulatory authorities.
It also involves a thorough examination of all processes and a comparison of requirements across these authorities. Operating in the Middle East, this professional training program has attracted numerous classes and hundreds of graduates from over 17 countries.
Covering a wide spectrum of regulations and processes, including drugs, biologics, medical devices, cosmetics, dietary supplements, Good Manufacturing Practice (GMP), and clinical trials.
Program Objective
This 165 hours training program is designed to develop Regulatory Affairs professionals with a thorough understanding of regulatory processes and the ability to interact effectively with regulatory authorities including U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), Saudi Food and Drug Administration (SFDA), and United Arab Emirates Ministry of Health and Prevention (MOHAP) in the USA, Europe, Saudi Arabia, and UAE respectively. To enhance the program’s richness and provide students with a unique learning experience, the curriculum incorporates various learning methods, including critical thinking exercises aimed at presenting real-world cases. This comprehensive course is licensed by the Jordanian Ministry of Higher Education through Philadelphia University, formally recognized as a Professional Training Program.
Why Choose RADEX Regulatory Affairs Professional Training Program?
In our 26-weeks RADEX Regulatory Affairs Professional Training Program, students will learn about the roles and responsibilities of regulatory affairs professionals in the development of new medical products.
- International Accreditation: RADEX Regulatory Affairs is licensed by the Jordanian Ministry of Higher Education through Philadelphia University, where it is officially recognized as a Professional Training Program.
- Exclusive International Experience: Our students will explore the regulatory jurisdiction of the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), Saudi Food and Drug Administration (SFDA), and United Arab Emirates Ministry of Health and Prevention (MOHAP).
- Distinctive Topics Diversity: Our program prepares students with the required skills, integrated knowledge, and broad perspectives about the laws and regulations that apply to drugs, biologics, biosimilars, medical devices, combination products, dietary supplements, cosmetics, and pharmacovigilance to enter national and international markets.
- Exposure to Variety of Occupational Fields: The program covers all fields of Regulatory Affairs, comprising of regulatory compliance, operational, strategic, clinical, CMC, and Submission Specialist Regulatory Affairs.
- Expert Faculty Instructors: RADEX decided to hire highly qualified regulatory affairs professionals to provide their knowledge and experience in global regulatory affairs regulations, and that is how RADEX was formed in Jordan in 2017.
- Reliable Textbooks with Copyrights: The program’s materials are arranged in textbooks book titled “Regulatory Affairs of Drugs and Medical Devices” with copy rights from USA, Saudi Arabia, and Jordan.
- Phenomenal Knowledge and Skills: We provide critical thinking workshops that allow trainees to apply their theoretical earned knowledge in a practical way.
- Hands-on Experience to Fit Career Goals: Focus on the business side with the hands-on projects, as trainees are exposed to real life experience. This practical experience improves our graduates’ resume while demonstrating to potential employers that they possess the transferable abilities necessary for career success.
- Flexible For Working Professionals: The online evening program is designed to provide working professionals with the flexibility they need to maintain work, life, and school balance.
- Join Professional Network: Graduates of RADEX, become part of an international community of regulatory affairs professionals who work in companies and regulatory authorities around the world.
Fees:
Regulatory Affairs of Drugs and Medical Devices (USA, Europe, & GCC) Professional Training Program
SAR/AED: 11,000 | JOD: 2,100 | USD: $3,000
2 - Pharmacovigilance and Vigilance, An International Perspective Professional Training Programs Certificate – (Europe, KSA, UAE, & Jordan): 56 Training Hours – 4 Weeks
Program Description
A program that is tailored to deliver the knowledge that students need regarding the different authorities including Europe, Saudi Arabia, UAE, and Jordan. 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.
The course is structured to offer participants a comprehensive understanding and diverse insights into the regulations, requirements, and processes governing pharmacovigilance (PV) for drugs and biologics, as well as vigilance systems for medical devices.
Throughout the program, participants will gain thorough knowledge of Pharmacovigilance principles and the procedures for reporting Adverse Events (AE) across multiple international jurisdictions, including Europe, Saudi Arabia (KSA), United Arab Emirates (UAE), and Jordan. This will enable them to develop proficiency and ensure compliance in ensuring the safety of drugs and medical devices.
Program Objective
This 56-training hours program aims to support pharmacovigilance professionals in understanding the Pharmacovigilance fundamentals, covering different concepts, and to delve into pharmacovigilance departmental operations, including Qualified Person responsibilities, process flows, documentation mastery, adverse events reporting skills, and the implementation of Good Vigilance Practice (GVP) principles for regulatory compliance and patient safety enhancement. Also, our unique program will deeply explain the structure and contents of the Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Sub-System Master File (PSSF) in accordance with guidelines provided by the European Medicines Agency (EMA).
Why Choose RADEX Pharmacovigilance and Vigilance Professional Training Program?
In our 4 weeks RADEX Pharmacovigilance and Vigilance Professional Training Program, students will learn about the roles and responsibilities of pharmacovigilance professionals for regulatory compliance and patient safety enhancement.
- International Accreditation: RADEX Pharmacovigilance program is officially recognized as a Professional Training Program.
- Exclusive International Experience: Our students will explore the regulatory jurisdiction of the European Medicines Agency (EMA), Saudi Food and Drug Administration (SFDA), United Arab Emirates Ministry of Health and Prevention (MOHAP), and Jordan Food and Drug Administration (JFDA).
- Distinctive Topics Diversity: Our program prepares students with the required skills, integrated knowledge, and diverse insights about the laws and regulations that apply the requirements and processes governing pharmacovigilance (PV) for drugs and biologics, as well as vigilance systems for medical devices.
- Exposure to Variety of Occupational Fields: The program covers all skills of pharmacovigilance including Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), Qualified Person skills, pharmacovigilance department processes, Pharmacovigilance System Master File (PSMF/ PSSF), Good Vigilance Practice (GVP), and adverse event reporting procedures.
- Expert Faculty Instructors: RADEX decided to hire highly qualified pharmacovigilance professionals to provide their knowledge and experience in global pharmacovigilance regulations.
- Reliable Textbooks with Copyrights: The programs materials are arranged in a textbook book titled “Pharmacovigilance and Vigilance: An International Perspective” with copy rights from Jordan.
- Phenomenal Knowledge and Skills: We provide critical thinking workshops that allow trainees to apply their theoretical earned knowledge in a practical way.
- Hands-on Experience to Fit Career Goals: Focus on the business side with the hands-on projects, as trainees are exposed to real life experience. This practical experience improves our graduates’ resume while demonstrating to potential employers that they possess the transferable abilities necessary for career success.
- Flexible For Working Professionals: The The online evening program is designed to provide working professionals with the flexibility they need to maintain work, life, and school balance.
- Join Professional Network: Graduates of RADEX, become part of an international community of regulatory affairs professionals who work in companies and regulatory authorities around the world.
Fees:
Pharmacovigilance and Vigilance, an International Perspective (Europe, KSA, UAE, & Jordan) Professional Training Program
SAR/AED: 4,150 | JOD: 780 | USD: $1,100
3 - Customized Training Programs
At RADEX, we provide customized training programs tailored to each pharmaceutical company’s specific needs, whether conducted online or onsite. These programs are designed based on the topics and areas of interest identified by the client. We have successfully delivered numerous customized programs for many manufacturers, pharmaceutical/ medical device companies, and health authorities in the past.
Fees:
The fees for these programs are determined based on the client’s requested topics and the chosen timeframe, whether for online or onsite delivery.