2025-03-28 2025-03-28 Novotel Frankfurt City +49 69 79303-0 +49 69 79303-930 Novotel Frankfurt City Lise-Meitner-Str. 2, 60486 Frankfurt Frankfurt, 60486 1,990 € zzgl. MwSt. Ala'a Saleem https://forum-institut.de/seminar/25052510-marketing-authorisation-and-market-access-in-the-middle-east/referenten/25/25_05/25052510-marketing-authorisation-and-market-access-in-the-middle-east_saleem-alaa.jpg Marketing Authorisation and Market Access in the Middle East

This face-to-face event offers a comprehensive overview of marketing authorisation and market access in the Middle East, covering key topics like market entry, intellectual property, lifecycle management, pharmacovigilance and quality considerations, with a focus on Gulf Cooperation Council, Saudi Arabia, the UAE, Jordan and Syria.

Topics
  • Pharmaceutical marketing authorisation and market access in the GCC and key national markets
  • Intellectual property: Patents, data protection and regulatory considerations
  • Fast-track pathways, distribution strategies and legal frameworks
  • Dossier assessment, submission processes and compliance essentials
  • Key quality and production requirements for market entry
  • Import regulations, pharmacovigilance obligations and post-approval maintenance


Who should attend
This seminar is suitable for:
  • Regulatory affairs professionals in the pharmaceutical and healthcare industries
  • Market access and business development managers focusing on the Middle East region
  • Quality assurance and production specialists involved in regulatory compliance
  • Legal and intellectual property experts in the pharmaceutical sector

Participants should have a basic understanding of pharmaceutical regulatory frameworks and market access processes.
Aims and objectives
This in-person event provides you with a comprehensive understanding of marketing authorisation and market access in the Middle East, focusing on both GCC-wide and national regulatory frameworks. Through expert-led presentations and interactive discussions, you will gain in-depth knowledge of key topics such as market entry strategies, intellectual property, product classification, pricing regulations and distribution models. The event also covers legal frameworks and lifecycle management, including dossier assessments, eCTD submissions and import regulations. Additionally, it explores pharmacovigilance requirements, post-approval maintenance and quality considerations, with a particular focus on Saudi Arabia, the UAE, Jordan, and Syria.

There will be ample opportunity for individual questions, with experts on hand to provide tailored insights and guidance.
Your benefit

  • Gain a clear overview of marketing authorisation pathways across the Middle East.
  • Develop a targeted authorisation strategy by assessing regulatory requirements and market conditions.
  • Deepen your understanding of quality, production, import regulations and eCTD dossier submissions.
Benefit from expert insights into intellectual property, pricing regulations and pharmacovigilance.
Connect with industry professionals to exchange experiences and best practices.

Marketing-Authorisation-and-Market-Access-in-the-Middle-East

Marketing Authorisation and Market Access in the Middle East: GCC and National Markets

Connect face-to-face with regional experts from the Middle East in this exclusive in-person event!

Benefits
  • Excellent local experts
  • Networking with industry professionals
  • Targeted regulatory and market strategy
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25052510

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Alles auf einen Blick

Termin

26-27/05/2025

26-27/05/2025

Zeitraum

Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm

Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm
Veranstaltungsort

Frankfurt

Frankfurt

Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

This face-to-face event offers a comprehensive overview of marketing authorisation and market access in the Middle East, covering key topics like market entry, intellectual property, lifecycle management, pharmacovigilance and quality considerations, with a focus on Gulf Cooperation Council, Saudi Arabia, the UAE, Jordan and Syria.

Topics

  • Pharmaceutical marketing authorisation and market access in the GCC and key national markets
  • Intellectual property: Patents, data protection and regulatory considerations
  • Fast-track pathways, distribution strategies and legal frameworks
  • Dossier assessment, submission processes and compliance essentials
  • Key quality and production requirements for market entry
  • Import regulations, pharmacovigilance obligations and post-approval maintenance


Who should attend
This seminar is suitable for:
  • Regulatory affairs professionals in the pharmaceutical and healthcare industries
  • Market access and business development managers focusing on the Middle East region
  • Quality assurance and production specialists involved in regulatory compliance
  • Legal and intellectual property experts in the pharmaceutical sector

Participants should have a basic understanding of pharmaceutical regulatory frameworks and market access processes.

Aims and objectives

This in-person event provides you with a comprehensive understanding of marketing authorisation and market access in the Middle East, focusing on both GCC-wide and national regulatory frameworks. Through expert-led presentations and interactive discussions, you will gain in-depth knowledge of key topics such as market entry strategies, intellectual property, product classification, pricing regulations and distribution models. The event also covers legal frameworks and lifecycle management, including dossier assessments, eCTD submissions and import regulations. Additionally, it explores pharmacovigilance requirements, post-approval maintenance and quality considerations, with a particular focus on Saudi Arabia, the UAE, Jordan, and Syria.

There will be ample opportunity for individual questions, with experts on hand to provide tailored insights and guidance.

Your benefit

  • Gain a clear overview of marketing authorisation pathways across the Middle East.
  • Develop a targeted authorisation strategy by assessing regulatory requirements and market conditions.
  • Deepen your understanding of quality, production, import regulations and eCTD dossier submissions.
Benefit from expert insights into intellectual property, pricing regulations and pharmacovigilance.
Connect with industry professionals to exchange experiences and best practices.

Detailed programme

Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm

09:00

Welcome & Introductions
  • Introduction of speakers and participants
  • Opening remarks, seminar objectives and agenda overview

09:20

Political Landscape & Market Access in the GCC Pharmaceutical Sector
  • Current political climate
  • Preliminary considerations: National vs. GCC Market Access - pros and cons

10:00

Key Intellectual Property (IP) Insights
  • Patent requirements: Challenges in Saudi Arabia (KSA) versus other GCC countries
  • Data protection for preclinical and clinical data: Comparative analysis of KSA and other GCC countries

11:00 Coffee Break


11:30

Product Classification
  • Classification of pharmaceuticals,drug-device combination productsand medical device

12:00

Marketing Authorisation Pathways
  • Fast-track options for innovative medicines: Eligibility criteria and application procedures
  • Overview of of key submission portals and updates on digital processes

13:00 Lunch Break


14:30

Market Access and Distribution Strategies
  • Roles and responsibilities of agents, distributors and scientific offices
  • Two-agent requirement and non-exclusive contracts: Legal frameworks, benefits and potential challenges
  • Liability insurance

15:15

Ensuring Product Integrity - Challenges
  • Track and trace (UAE vs. others)

15:45 Coffee Break


16:00

Pharmaceutical Pricing Regulations and Controls in the GCC
  • Regulatory frameworks for price control across GCC countries
  • Key pricing strategy considerations

16:30 Q&A Sessions for individual questions


09:00

Dossier Assessment by the Authorities
  • Submission & review process overview
  • Formative vs. substantive review processes

10:00

Import Regulations and Electronic Submissions
  • eCTD submissions: Handling variations, renewals and product information texts
  • Special import permits: Application processes, required documents and managing FOC samples

11:00 Coffee Break


11:30

Quality & Production - Essentials for Regulatory Affairs
  • Manufacturing licence requirements
  • Stability testing requirements for climatic zones in the Middle East
  • Batch release procedures
  • CPPs & country of origin considerations

13:00 Lunch Break


14:15

Pharmacovigilance Requirements
  • Reporting obligations
  • Timelines

14:45

Post-Approval Maintenance Duties
  • Managing variations, renewals, and post-approval changes: Timelines, documentation, compliance strategies

15:45 Coffee Break


16:00 Q&A Sessions for individual questions


Your Benefits

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