We currently offer professional courses accredited by reputed universities and associations worldwide and also, in our home ground UAE, we have collaboration with the reputed Dubai Pharmacy College, which is the country’s first pharmacy institution.
Professional Regulatory Affairs GCC Certification
The course is designed for students and industry professionals who need to advance their career as regulatory affairs professional and stay ahead of the competition. This course will help students to develop up-to-date knowledge of regulatory affairs process and legislations especially in UAE and gulf region.
- 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.
- 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
- 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 recognized college.
- Personal who needs RA certification for the purpose of relocation or immigration
- Introduction to Regulatory Affairs
- Licensing Requirements for Pharma Entities in UAE
- Common Technical Document (CTD)
- Electronic Common Technical Document (E-CTD)
- Pharma Registration in GCC
- General sales list pharmaceuticals in GCC
- Registration of cosmetics in GCC
- Labeling Guidelines
- Registration Of Medical Device in GCC
- Stability Study Related to GCC Region
- Product Life Cycle Management
- Good Manufacturing Practice (GMP)
- Communication Skills in Regulatory Affairs & RA Interview
- One or Two taught modules will be delivered by regulatory experts from industries and academia at the Dubai Pharmacy College.
- The course is conducted twice a year and only Fridays for 14 weeks.
- Participants will be evaluated based on individual module assessments that will be held after each module completion
- The certificate will be issued after the course ends
Pharmacovigilance GCC Certification
Industry Professionals interested in improving their qualifications and advancing their PV Career in the GCC region will find this course especially useful. Taken by PV experts within and beyond the pharmaceutical industry, this course offers updated knowledge and best practices needed to thrive in the PV industry to Pharma professionals.
Pharmacovigilance (PV) is a discipline which is mainly concerned with the safety of pharmaceuticals. Due to the increasing need for new drugs, pharmacovigilance is one of the fundamental parts of the product life cycle. That is why the international PV framework of regulations, policies and guidelines are essential to safeguard the public health. In the last few years, GCC countries have strengthened their pharmacovigilance laws and regulations. To market their products in the GCC, pharmaceutical companies will have to comply with both international and national PV requirements. This has created many opportunities for (new) PV professionals to advance their career and strengthen their position in the field of pharmacovigilance.
- Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
- The International Framework for Pharmacovigilance.
- Good Vigilance Practices (GVP)
- Individual Case Safety Report Management
- Safety Communication & Aggregated Safety Reporting
- Signal Management System
- The Pharmacovigilance System and The Pharmacovigilance System Master File
- Risk Management System
- PVRegulations and Reporting Systems in the GCC
- The Role of the MAH & QPPV