2025-05-21 2025-05-21 , online online, 1,990 € plus tax Ala'a Saleem https://forum-institut.com/seminar/25092511-pharmaceutical-marketing-authorisation-and-market-access-in-the-middle-east-gcc-and-nati/referenten/25/25_09/25092511-marketing-authorisation-and-market-access-in-the-middle-east_saleem-alaa.jpg Pharmaceutical Marketing Authorisation and Market Access in the Middle East: GCC and National Markets

This online 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 online training provides you with a comprehensive understanding of marketing authorisation and market access in the Middle East region, 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

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

Connect with regional experts from the Middle East in this exclusive online traning!

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

Webcode 25092511

Book now

JETZT Buchen
Speakers

Ala'a Saleem

Science Forum (SIPS), Amman, JORDAN

Deputy General Director "Technical Affairs" 15 years’ experience in different fields comprising RA and IPR in the pharmaceutical area. As a member of SIPSMENA team, Ala’a has been subjected to various other areas in the pharmaceutical industry such as agent selection, legal requirements, market access and others.
More information please click here.

Dr Mohammed Saleem, PhD

Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN

General Director of SIPS (Science Forum for Research & Consultancy). He has served as a senior consultant to many UN organisations and in projects of the World Bank, the UNDP and the WHO. Dr. Saleem has served as head of the IPR Committee & also as a member of the technical review board on herbal medicine & natural products at the Jordan FDA, as well as head of the LES-AC "Life Science Committee".
More information please click here.

Everything at a glance

Appointment

22-23/09/2025

22-23/09/2025

Period

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
Venue

online

online

Downloads
Fee

Event - 1,990 € plus tax
The participation fee includes downloadabe documentation, a certificate, access to the Learning Space and technical support including PreMeeting.

Event - 1,990 € plus tax
The participation fee includes downloadabe documentation, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Verena Planitz
Conference Manager

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

Details

This online 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 online training provides you with a comprehensive understanding of marketing authorisation and market access in the Middle East region, 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


11:15

Product Classification
  • Classification of pharmaceuticals, drug-device combination products and medical device

11:45 Practical Exercise


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


14:00

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

14:45

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

15:15 Coffee Break


15:30

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

16:00 Q&A Sessions for individual questions


09:00

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

09:00 Day two


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


11:15

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

12:45 Practical Exercise


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


17:00 End of Day two


Your Benefits

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

of 5 stars of all ratings from 2024

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