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 processes and legislation, especially in the UAE and Gulf region.
The regulatory standards related to healthcare products have 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 course, which will allow you to apply for an international certificate.
You might be interested in another Healthcare Management certificate 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.
Course Outline
- Introduction to Regulatory Affairs in the UAE and GCC
- Regulatory Communication Channels
- Regulatory Environment in the EU / USA / Canada
- Regulatory Project Management Coordination
- Product Lifecycle
- Role of the Regulatory Professional
- Supplier Chain Management and Controls
- Introduction to Regulatory Affairs in the UAE and GCC
- Regulatory Communication Channels
- Regulatory Environment in the EU / USA / Canada
- Regulatory Project Management Coordination
- Product Lifecycle
- Role of the Regulatory Professional
- Supplier Chain Management and Controls
Module 2: Pharmaceutical Regulations
- Chemistry, Manufacturing, and Controls
- Global Regulatory Strategy Essentials
- Advertising and Promotional Labeling
- Introduction to Pharmacovigilance
- Regulation of Biosimilars
- Regulation of Combination Products
- Regulation of Generic Drugs
- REMS and RMPs
Module 3: Quality Aspects
- Overview of Good Clinical Practice Training
- Good Laboratory Practice Compliance
- What is GMP | cGMP | Good Manufacturing Practice
- Quality System (QS) Regulation/Medical Device Good Practice
Module 4: Clinical Data
- Clinical Research Trials
- ICH Good Clinical Practice
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- 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
