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Pharmaceutical Regulatory Affairs in the Middle East, Dubai

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Pharmaceutical Regulatory Affairs in the Middle East, Dubai

This course will provide you with an essential overview of the critical areas of pharmaceutical regulatory affairs in the Middle East.

Pharmaceutical Regulatory Affairs can be a confusing and complicated place, mainly if you have no formal industry background.

This course will help students to develop up-to-date knowledge of regulatory issues process and legislation, especially in the UAE and Gulf region.

The regulatory standards related to healthcare products has seen rapid advancement due to changes in product safety, regulatory compliance, technological transformation, enhanced understanding of disease characteristics, and customer requirements.

Professionals working in regulatory affairs departments play a vital role in making sure that all biopharmaceutical products and medical devices developed by their organization comply with regulations put forth by regulatory authorities.

Regulatory professionals do not just function in the initial application process, but also work in the licensing and marketing phases – ensuring that all procedures and products meet necessary safety and efficacy requirements.

Regulatory affairs professionals are in high demand, and the career opportunities in this area are phenomenal.

The Pharmaceutical Regulatory Affairs Certificate provides a cost-effective, convenient option that will equip you or your organizational team with the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition.

Regardless of whether someone is new to the regulatory profession, pharmaceuticals industry, transitioning from a related discipline or only needs to refresh their knowledge, this comprehensive and flexible resource will meet the learning needs of you as an individual or your entire team.

This is an officially accredited RAPS course, which will allow you to apply for an international certificate.

You might be interested in another Healthcare Management certificates as a next step.

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  • View Schedule
  • COURSE TYPE Intermediate to Advanced
  • COURSE NUMBER
  • DURATION 1 month
  • COURSE ACCREDITED BY RAPS

YOU WILL LEARN HOW TO

Strategic Axis, regulatory affairs program, provides a comprehensive background and training required of regulatory affairs professionals to address domestic and international regulatory statutes and laws.

The Regulatory Affairs program includes modules on: laws, regulations, and guidelines, investigational and marketing applications, technical writing, negotiation skills, development of New Drug Application (NDA) submissions, labeling and drug Information, Common Technical Documents (CTD), Notice of Compliance (NOC), Good Clinical Practices (GCPs), requirements for ongoing post-marketing surveillance and post-marketing changes, communication and management skills essential for the prosperous regulatory affairs professional in an industry work environment.

IMPORTANT COURSE INFORMATION

Certificate

Participants who fully attend this course and complete the test on the last day will receive a Strategic Axis Professional Certificate (SAPC). SAPC certificates are regionally recognized and can be quite valuable when applying for more senior roles within the organization or outside.

Additionally, all participants can apply for an international certificate from RAPS.

Course Outline

Modules:

Module 1: Essentials and Overview

  • Effective Regulatory Communication
  • Ethics
  • Introduction to Regulatory Affairs in the UAE and GCC
  • Introduction to Regulatory Affairs in the EU
  • Introduction to Regulatory Affairs US and Canada
  • Introductory Medical Writing
  • Project Management for Regulatory Professionals
  • Regulatory Due Diligence for Product Development
  • Role of the Regulatory Professional
  • Supplier Management
  • Supply Chain Controls

Module 2: Pharmaceutical Regulations

  • Chemistry, Manufacturing, and Controls
  • Global Regulatory Strategy for Pharmaceuticals
  • Pharmaceuticals: Advertising and Promotional Labeling
  • Pharmaceuticals: Compliance & Audits
  • Pharmaceuticals: Definition & Lifecycle
  • Pharmacovigilance
  • Regulation of Biosimilars
  • Regulation of Combination Products
  • Regulation of Dietary Supplements and NHPs
  • Regulation of Generic Drugs
  • REMS and RMPs

Module 3: Quality

  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Quality System Regulation (QSR)

Module 4: Clinical

  • Globalization of Clinical Research Trials and Investigations
  • Good Clinical Practice (GCP)
  • Understanding & Managing the Clinical Trial Process

Module 5: The Pharmaceutical Regulatory Environment in The Middle East

  • Markets and culture
  • Healthcare
  • Business culture
  • Regulatory environment and characteristics
  • General regulatory requirements
  • Company and product registration
  • Variations and renewals
  • Regulatory summary

Module 6: eCTD Submission and Approval in UAE

  • Marketing Authorization Applications
  • Labels and leaflets
  • Lifecycle management, including variations
  • Marketing Authorization Strategy
  • Post- Authorization Activities
  • Technical Writing and Scientific Communication
  • Chemistry Manufacturing and Control
  • Labeling and Product Summaries
  • Global Regulatory Strategies
  • CTD Modules overview
  • E-CTD Guidelines
  • Pharmacovigilance Communication Skills in Regulatory Affairs & RA Interview
  • In The Classroom

  • Live, Online

  • Private Team Training

  • Indiviual Private Session

Please Register for More Information

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