Overview:
The MENA region suffers from a Drug & Device Lag, meaning innovative products typically do not reach the market for 10+ years, after they are approved and launched in the U.S. or EU. Because of this, there exists significant opportunity for U.S. and EU developed products, if the regulatory hurdles can be navigated
The affluence in the major markets in the MENA region allow for good medical care, product reimbursement and a knowledgeable infrastructure to aid advanced product growth.
Distribution is sophisticated across the region able to assist on Customs Clearance, Local Testing, Warehousing and Distribution of product.
The regulatory framework and Agency structure continues to grow with additional Regulations, Requirements and people resources being added to reduce licensing timelines and Agency responsiveness. There is little harmonization between countries and significant document legalization and translation requirements exist across the region. Therefore, having a strategy and plan becomes even more critical for success.
Local entities are needed to apply for product registration in most countries. There is a "right way" and "wrong way". This 90-minute webinar will update you with several of these suggested strategic steps.
Why you should Attend:
This course specifically focuses on comparing similarities and differences across regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in the targeted markets: UAE, Israel, Saudi Arabia, Turkey, Kuwait, Bahrain and Jordan. These comparisons will allow applicants & developers to determine “if and where” MENA should fit in the company’s global footprint for its’ products. It will clearly outline what one can expect for unique requirements and review timelines, so good internal decisions can be made. This Course would be perfect for personnel from Regulatory, Business Development, Manufacturing, Quality, CMC and Strategic Planning functions.
Learning Objectives:
This webinar is designed to provide an overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics, combination products) as an importer into MENA.
It will provide training on:
- The Regulatory Agencies across MENA
- Understanding the specific requirements for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- How to begin your company’s involvement in MENA: local licenses, personnel and facilities required, working with distributors
- Clinical Trials: Are they needed locally? Why consider MENA?
- Understand the importance of Reference Country Licenses and which ex-MENA region’s regulatory alignment will be most important for entering MENA
- Understanding the local concerns and specific challenges in working with MENA Regulatory Bodies
- Understanding the Local Culture: realistic expectations, timing on reviews, effective strategies for adding MENA to your company’s global market presence
- Information necessary for effective dossier preparation
- Strategies for streamlining the registration application process for faster approvals
- Maintenance of Authorized Products: Variations & Amendments to Licenses
Areas Covered in the Session:
- Country Profile / Healthcare System
- Key Country Information: Making Comparisons on Requirements
- Strategic Considerations: Why MENA? / Possible Hub Locations
- Governmental & Regulatory Authorities / Agencies / Structure
- Concept & Importance of Reference Countries
- Company Establishment: Who Can Register & Local Representation
- Partner Companies / Local Regulatory Support
- Elements to Consider in Determining Country Priority
- Operational Considerations; Importance of Local Distributors
- Requirements to Conduct Clinical trials
- Licensing Pharmaceutical & Biologic Products Across MENA
- Licensing Medical Devices Across MENA
- Variations and Amendments to Licenses
- Product License Renewals
- GMP Clearance for Drugs and Devices
- Import / Export / Customs Clearance
- Taxes / VATs / Duties
- Local Customs / Cultural Challenges
- Working with Local Agencies / Authorities
- Conclusions
Who Will Benefit:
- Regulatory, Quality, Manufacturing, Global Business Development and General Management personnel whose responsibilities require knowledge of the MENA region regulatory, quality and import / export requirements
- Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP
- Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider the individual MENA countries into one’s Global Business Strategy