Medical Device Regulation Masterclass - MENA

 

Course start dates – to be announced

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 trainings 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.

Why to join this Course?

  • Network, and share experiences with other industry colleagues.
  • Get certified from Dubai Pharmacy College as a RA specialist in medical devices for MENA.
  • Get the know-how, regulations, and guidelines in Medical devices sector.
  • Understand the certifications and technical documents that is usually medical device manufacturer prepare.
  • A gate way for a new career opportunity.
  • The attendees will be supported by a letter from the college to find an internship opportunity.
  • PRA consultancy will guide the participants whenever needed.


Who Should Attend?

This course is ideal for medical or science bachelor 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 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.


Experience / Prerequisite Experience

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.

Course Modules
Introduction to Medical Device (IVDs).
EU Medical device regulations / (IVDs)( MDD and new MDR).
GCC Medical Device registration (part 1) – KSA.
GCC Medical Device registration ( Part2) – UAE , Oman , Bahrain , Qatar, and Kuwait.
Egypt and Sudan Medical devices regulation.
Morrocoy, Algeria, Libya, and Tunisia Medical device regulations.
Levant Medical device regulations(Syria, Jordan, Palestine, Lebanon, and Iraq).
Materiovigilance in EU & and QSR in ME.


Course Structure & Duration:
  • One or two taught modules will be delivered by the speaker from industries and academia from the Dubai Pharmacy College.
  • The course is conducted once a year, only on Fridays for 2 months.
  • 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.
  • Course is available online.
For more information on the course and registrations, please contact: +971 4 299 9398/ +971 4 255 5728 or email training@pra-me.com or visit us on www.pra-me.com