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Pharmaceutical Regulatory Affairs in the Middle East, Dubai

Pharmaceutical Regulatory Affairs

This seminar 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.

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 legislation, especially in 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 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 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.

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: Economic overview of the Middle East

Population and GDP per capita

Unemployment rate

GDP real growth rate

Inflation rate

Healthcare spend per capita

Centralised registration in the Gulf

Gulf Central Committee for Drug Registration (GCC-DR)

SGH Tender

Middle East Regulatory Conference (MERC)

MERC follow up activities

Industry regulatory groups and activities

Local trade associations

Module 2: 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

Practical advice on record in each region

Module 3: Regulatory Affairs Level I and Level II

Good Manufacturing Practices Level I
Introduction to Pharmaceutical Manufacturing Methods
Good Manufacturing Practices Level II
Regulatory Submission and Preclinical – Drug
Intellectual Property
Clinical – Drug In Class

Module 4: Introduction to Clinical Research and Drug Safety

Good Manufacturing Practices Level III

Generics Drug

Natural Health Products

Biologics/Biotechnology Products

Medical Devices

 

Module 5: CTD Submission and Approval

  • Marketing Authorisation Applications
  • Labels and leaflets
  • Lifecycle management, including variations
  • Marketing Authorisation Strategy
  • Post- Authorisation 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

 

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