Deepen your understanding of pharma regulatory affairs in the MENA region to create a strategy for faster drug approval
Course Overview
As healthcare spending continues to rise in the Middle East and North Africa (MENA), the region has become a key growth target for pharmaceutical and biopharmaceutical companies. One challenge faced by companies is overcoming the non-harmonised regulatory landscape which contains different systems, requirements, and procedures. Having a solid regulatory strategy in the region will require an in-depth knowledge of the regulations and can open up a growing market.
通过结合理论和实际情况tudies, this course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in MENA. You will cover specific regulatory requirements, new developments or particular questions of interest within the region to provide you with the confidence and competence to gain approval and manage products in these markets. Key countries discussed in the course include:
North Africa - Morocco, Tunisia, Algeria, Libya, and Egypt
Middle East - Kingdom of Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman, and Yemen
Near East - Jordan, Lebanon, and Iraq
Eurasia - Turkey
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contactlifesciences-training@informa.com.
What will you learn?
The MENA market landscape
The MENA market landscape
Gain a critical overview of the cultural and economic environment for pharmaceuticals in the MENA region
Stakeholders in MENA
Stakeholders in MENA
Explore the organisation and structure of key regulatory authorities and working groups
Documentation requirements
Documentation requirements
Examine documentation requirements including structure and format of dossiers
Case studies
Case studies
Plan for realistic submission timelines based on real examples
How to strategise
How to strategise
Set up a regulatory strategy for the lifecycle management of your product
Key requirements
Key requirements
Gain a critical overview of regulatory requirements for gaining marketing authorisation in key MENA markets
Who is this course for?
This course is suitable for professionals who are working in/working with affiliate offices in or are thinking of expanding into the MENA region.
In particular, the course will benefit Managers, Consultants, Project Leaders, and Project Officers working in the areas of:
- Regulatory Affairs
- Regulatory Operations
- International Regulatory Affairs
- Emerging Markets
- Global Regulatory Operations
- Dossier Management
- Information Management
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.
