Who should attend
This drug regulatory affairs course on “Drug Registration and Regulation in UAE” provides deep insight on the marketing authorization process in UAE. The course provide detail training on drug Registration Procedure in United Arab Emirates. It covers recent regulations, registration procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover course focus on the regulatory affairs strategic planning for registration of pharmaceutical, biopharmaceutical in United Arab Emirates.
The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
The course can be completed at any place, allowing the user to stop and start at their leisure.
- Course Code: RYD-031
- Course Title: Advance Certification in Drug Registration & Regulation in UAE.
- Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
- Duration: 1 Month.
- Eligibility: Graduation in any discipline. Even the final year student can join the course.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
This UAE Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the United Arab Emirates pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.
Key features of the course
- Orientation to practical understanding in the entire drug regulation, registration procedure of United Arab Emirates. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations.
- The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
- Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
- Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.
- Freshers and beginners. Those who want to know about the UAE Pharmaceutical Market, Regulation.
- Drug regulatory affairs professionals. Who want to enhance knowledge about the United Arab Emirates regulatory affairs.
- Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in UAE.
Few of the similar courses
Pharmaceuticals are regulated in the United Arab Emirates (UAE) by several government authorities, primarily the UAE Ministry of Health and Prevention (MOHAP). The regulation of pharmaceuticals in the UAE is stringent and aims to ensure the safety, efficacy, and quality of pharmaceutical products available in the market.
Here is an overview of how pharmaceuticals are regulated in the UAE:
- Before a pharmaceutical product can be marketed and sold in the UAE, it must undergo a rigorous registration process with MOHAP.
- The registration process includes a comprehensive evaluation of the product’s safety, efficacy, quality, and manufacturing processes.
- Applicants are typically required to provide detailed documentation, including clinical trial data, quality control information, proof of Good Manufacturing Practice (GMP) compliance, and packaging and labeling details.
- Foreign pharmaceutical companies must appoint a local agent or distributor who is registered with MOHAP to facilitate the registration process and represent their interests in the UAE.
- MOHAP regulates pharmaceutical prices in the UAE. Pharmaceutical companies must adhere to pricing guidelines set by the government.
- Pharmaceutical companies are required to establish pharmacovigilance systems to monitor the safety of their products in the UAE market.
- Reporting of adverse events and product safety issues is mandatory.
Labeling and Packaging:
- Pharmaceutical products must have labeling and packaging that adhere to specific UAE regulations.
- Arabic is typically required as the primary language on product labels.
Quality Control and Manufacturing:
- Pharmaceutical manufacturing facilities must meet GMP standards and are subject to inspections by MOHAP to ensure compliance.
Import and Distribution:
- Companies involved in the import and distribution of pharmaceutical products must comply with specific regulations and may require licenses.
- Clinical trials of pharmaceutical products must be conducted in accordance with UAE regulations and require approvals from MOHAP.
- After registration, pharmaceutical products are subject to post-market surveillance to monitor their safety and efficacy in the UAE market.
Renewal and Maintenance:
- Pharmaceutical product registrations typically require periodic renewal. Companies must keep product information, quality data, and safety data up to date.
Pharmacy Practice and Dispensing:
- Pharmacy practice and the dispensing of pharmaceuticals are regulated to ensure that medications are dispensed by qualified professionals according to legal and ethical standards.
Controlled Substances: The UAE has strict regulations for controlled substances and narcotics. Special licenses and permits are required for their manufacture, import, export, and distribution.
It’s important to note that the regulatory landscape for pharmaceuticals in the UAE may change over time, and specific requirements can vary based on the type of product and its classification. Pharmaceutical companies seeking to enter the UAE market should work closely with regulatory consultants and legal experts who are well-versed in UAE pharmaceutical regulations to navigate the registration process successfully and ensure compliance with current requirements. Additionally, staying updated on the latest guidelines and regulations issued by MOHAP is essential for pharmaceutical companies operating in the UAE.