Academics

This course has been designed to help individuals build up a solid and a comprehensive framework in the medical device’s regulatory affairs, and to provide a basic understanding of the medical devices including IVDs., addressing market information, technical documents, and guidelines of the related authorities in MENA region.

We are a leading provider of professional training for the medical and pharmaceutical industry. Relying on our extensive training portfolio with expert instructors and recognized certifications. If you want to understand the rules that govern the Regulation of medical devices in the middle east Market place this course is perfect for you.

Upon completion of this course, participants should be able to:

• Gain an extensive understanding about the important rules and regulations of the medical devices and the elated authorities in the MENA region.
• Get an overview of the EU medical device regulations.
• Understand the need of the medical device regulations.
• Gain a comprehensive knowledge about the medical devices’ Market in the MENA region.
• Learn the steps and procedures of the MD registration in each country separately.
• Understand the technical dossier requirement and required certificates and how to obtain    them (such as CE and ISO).
• Get an overview of the importation procedures of the medical devices as per the competent authority.
• Understand the medical devices quality standards for the MENA region.

Our course is designed to equip participants with the real-world skills and knowledge required to be effective Regulatory Affairs professional in the medical device field.

Our course relies on a variety of training and facilitation methodologies and techniques used whenever applicable; these methods aim to enhance participant interaction while maximizing the learning journey.

Some Of these methods are:

• Interactive presentations.
• Individual and team exercises.
• One-to-one and group discussions
• Case studies.

• Modules are delivered from experts in the field from different industries and academia.
• The course is conducted once a year.
• Participants will be evaluated based on individual module assessments that
• will be conducted online.
• The certificate will be issued one month after the course end by Dubai pharmacy college
• Course is conducted online.

This course is ideal for medical or science bachelor’s degree holders who would like to start their RA career in medical devices and for newly joined employees to the RA departments in a medical device company, it can also be useful for the below:

• For a professional RA who will newly start working in MENA region and wants to know more about the MENA region’s regulations and guidelines of MD sector.
• Fresh graduates with pharma, biomedical engineering, pharmaceutical science, or any medical background who wants to start their career in the medical device industry.
• Regulatory Affairs Professionals who would like to enhance their knowledge in the Medical Device sector.
• Operation Managers within the medical device industry.
• Marketing & Business Development Professionals within the medical device industry.
• Internal and External audits of the medical device Industry.

• To Gain an extensive understanding about the important rules and regulations of the medical devices and the related authorities in the MENA region.
• To Get an overview of the EU medical device regulations. Understand the need of the medical device regulations.
• To Gain a comprehensive knowledge about the medical devices’ Market in the MENA region.
• To Learn the steps and procedures of the MD registration in each country separately.
• To Understand the technical dossier requirement and required certificates and how to obtain them (such as CE and ISO).

This course doesn’t require previous experience in regulatory affairs; however, it requires a relevant experience/ knowledge and/ or a bachelor’s degree in the pharma, biomedical engineering, pharmaceutical science, or any medical background which qualifies you to benefit from the training. We also consider applicants with different background on a case-by-case basis.

Sessions will start promptly at 10:00 AM and end at 2:00 PM (UAE Time) every Saturday and Sunday.