InstructorRoyed Training
TypeOnline Course
Student Enrolled2
Price$390 USD / 18500 INR.
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UAE drug registration and regulation training

Introduction

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About RA

UAE drug regulatory affairs training

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. UAE drug regulatory affairs

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 Snapshots UAE Drug Regulatory Affairs

  • 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 Registration Regulation 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 Drug Regulation and Registration in UAE 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.
  • It is online eLearning course. Hence, it provides opportunity to learn at anytime 24×7 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.

Who should attend UAE Regulatory Affairs course?

  • This course is ideal for the freshers and beginners. And those who want to know about the UAE pharmaceutical market, and UAE drug regulation.
  • Moreover this course is also ideal choice for the Drug regulatory affairs professionals, who want to enhance knowledge about the United Arab Emirates regulatory affairs.
  • Thirdly, this course will enhance the skills for professionals. Hence, those working in Business Development, Regulatory Affairs, IPR, strategic management professionals can find the course useful and effective for making advanced strategic planning for UAE drug registration.

International Drug Regulatory Affairs and Drug Biologic Medical Device Regulatory Affairs course course covers concepts and learning of UAE drug regulatory affairs. And also, UAE DRA is part of Advanced Certificate course in Middle East Regulatory Affairs and GCC Regulatory Affairs.

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). Also, 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:

Product Registration:

  • Before a pharmaceutical product can be marketed and sold in the UAE, it must undergo a rigorous registration process with MOHAP.
  • Moreover, the registration process includes a comprehensive evaluation of the product’s safety, efficacy, quality, and manufacturing processes.
  • Hence, Applicants need to provide detailed documentation, including clinical trial data, quality control information, proof of Good Manufacturing Practice (GMP) compliance, and packaging and labeling details.

Local Representation:

  • 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.

Pharmaceutical Pricing:

  • MOHAP regulates pharmaceutical prices in the UAE. Hence, pharmaceutical companies must adhere to pricing guidelines set by the government.

Pharmacovigilance:

  • Pharmaceutical companies are required to establish pharmacovigilance systems to monitor the safety of their products in the UAE market.
  • Hence, 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.
  • Keep a note that primary language in product label is arabic.

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:

  • Clinical trials of pharmaceutical products must be conducted in accordance with UAE regulations and require approvals from MOHAP.

Post-Market Surveillance:

  • 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. Hence, 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. Hence, to manufacture, import, export, and distribution, it requires special licenses and permits.

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. Therefore, 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.

Section 1Fundamental of Drug Regulatory | Discovery to Commercialization Process
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Concept of Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7USFDA expedited programs
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Authorized Generics: Key Understanding
Lecture 10Exploratory IND Vs. Traditional IND
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Trial | Detail Understanding
Lecture 12Clinical Trials Terminologies 
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Marketing Authorization Process
Lecture 16Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 17Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 18GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 19Drug Registration in UAE
Lecture 20Comparison of Requirement of Various Regulatory Bodies
Section 4Plant Regulatory Affairs
Lecture 21G1 Lecture Premises & Plant Layout Designing
Lecture 22G2 Lecture Sanitation and Hygiene
Lecture 23G3 Lecture Equipment Modules
Lecture 24G4 Lecture Production Modules
Lecture 25G5 Lecture Documentation
Lecture 26G6 Lecture Quality Control
Lecture 27G7 Lecture Product Complaint
Lecture 28G8 Lecture Storage Module
Lecture 29Certification Pharmaceutical Companies / Plants
Lecture 30Pharmaceutical SOPs Management from regulatory perspective
Lecture 31Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 32Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 33WHO-GMP Certification Scheme 
Lecture 34Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 5Submission Dossier Preparation
Lecture 35Chemistry, Manufacturing & Controls 
Lecture 36Introduction to Common Technical Document (CTD)
Lecture 37Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 38CMC Dossier & Compliance Management
Lecture 39Introduction to Electronic Common Technical Document (ECTD)
Lecture 40Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 41Discussion on 85 common deficiencies in CTD submission dossier
Section 6Stability Study Requirements
Lecture 42Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 43Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 44Stability Zone Finder
Lecture 45Stability Studies Case Discussions
Lecture 46Case Study: Managing Stability Study for Zone IV countries
Lecture 47Accelerated and intermediate testing conditions
Lecture 48Long Term Stability Testing Requirements
Lecture 49Testing Frequency
Lecture 50Bracketing
Lecture 51Matrixing
Section 7PKPD / Bioequivalence Study
Lecture 52PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 53Bioequivalence Study | Study design | Different types of BE Studies
Lecture 54Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 55Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 56Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 57Bioequivalence Study - Discussion - Dissolution Testing
Lecture 58Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 8Variation Management
Lecture 59Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 60Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 9Documentations for UAE drug registration | Discussions
Lecture 61Documentation Required for the drug registration in UAE
Lecture 62Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 63WHO-GMP Certification Scheme 
Lecture 64Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP