Professional Regulatory Affairs Certification - Egypt

 

Course start dates – to be announced

Professional Regulatory Affairs Certification - Egypt Course has been designed to educate young science and pharmaceutical graduates about the latest regulatory affairs, legislation, and documentation in Egypt.

This course is also aimed at industry professionals who will additionally learn about the complexities of regulatory submissions related to products such as pharmaceuticals, herbal and veterinary medicines, agrochemicals, medical devices, supplements, and cosmetics in the Egyptian market.

Certified by the Dubai Pharmacy College, our course is targeting those students who wished to enhance their qualifications in regulatory affairs and learn about best practices and standards in Egypt.

The course could also increase the possibilities of being selected for future jobs openings in the Egyptian healthcare sector.

Why to join this Course?

     
  • To build up a solid and comprehensive foundation in regulatory affairs.
  • To create a thorough understanding of important regulatory concepts.
  • To gain expertise in the field of regulatory affairs documentation and process in Egypt.
  • To encourage continuous learning and development in regulatory affairs field.
  •     To get certified from Dubai Pharmacy college.
  • To add a qualified certification to your CV.
  • To network and share experiences with other industry colleagues and speakers.


Who Should Attend?

  • Students who want to pursue their career in regulatory affairs.
  • Young regulatory professionals who need more knowledge in regulatory affairs.
  • Industrial personnel who want to change to regulatory affairs career.
  • Regulatory Affairs Professionals who need to be certified by a worldwide recognized college.
  • Regulatory Affairs Professionals starting new projects in Egypt.


Experience / Prerequisite Experience

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

Course Modules
Introduction to Regulatory Affairs.
Common Technical Document (CTD and E-CTD)
Pharma Regulation in Egypt with EDA - Egyptian Drug Authority ( registration , renewal, and variation).
Biologicals and biosimilar registration.
GXP from RA Perspective.
Fundamental Quality and Stability.
Market Access.
Labeling Guidelines.
Overview about Egyptian Pharmacovigilance regulations.
Medical Device Regulation in Egypt.
Food supplement Regulation in Egypt.
Cosmetics regulation In Egypt.
VET  Medicine Regulation in Egypt.
Importation Process.


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 online only 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.
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