Intellectual Property, Patents and Regulatory Affairs: Key Drivers in the Pharmaceutical Industry Strategy

Course Outlines:

Day 1: Intellectual Property Fundamentals

Session 1: Introduction to Intellectual Property (IP)

• Overview of Intellectual Property Rights (IPRs)
• Differentiating between research, invention, discovery and innovation.
• Importance of market research in IP strategy

Session 2: Deep Dive into Patents

• Patent basics: Definitions, criteria, and lifecycle
• Patent landscape in the region
• Methods of registering patents according to local and foreign regulations.
• Knowing the rights of the patent owner, the inventor, and the funding party of the research project regarding its invention.

Session 3: Patent Searching and Analysis

• Tools for patent searching and analysis
• Understanding patent databases and classifications

Session 4: IP and Business Strategy in the Pharmaceuticals

• Types of patents relevant to the pharmaceutical industry
• Competitive intelligence using patents

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Day 2: Patents in the Pharmaceutical Industry and Regulatory Affairs

Session 1: Patents in the Pharmaceutical Industry

• Role of patents in drug development and lifecycle management
• Patent cliffs and strategies to mitigate risks
• Importance of secondary patents (formulations, combinations, use claims)

Session 2: Regulatory Strategy and Patents

• Overview of SFDA and GCC health authority guidelines
• Patent-related requirements in regulatory submissions

With Group Work Cases by Pi Pharma Intelligence 

Speaker 1 Biography:

Mohammed Al-Hajeri – Founder and President, Madarej for Intellectual Property

With over 30 years of experience in the intellectual property (IP) field, Mohammed Al-Hajeri is a recognized expert in patent drafting, IP portfolio management, and consultation. He is the Founder and President of Madarej for Intellectual Property, which he established in 2024. As a certified IP agent, Mohammed specializes in patent drafting, Freedom-to-Operate (FTO) analysis, patentability searches, and IP audits. He also manages global IP filings and advises on R&D strategies and licensing agreements.

Before founding Madarej, he was the Founder and President of Mohammed F. Alhajeri for Intellectual Property, providing IP consultancy, patent drafting, and training services. His earlier roles include Senior Patent Specialist at Al Tamimi & Company, IP Consultant at Alshaya Lawyers, and various leadership positions at SABIC and Saudi Chemical Company.

Mohammed’s career also includes significant contributions to Saudi Aramco and King Abdulaziz City for Science and Technology (KACST), where he played a key role in developing Saudi Arabia’s patent system and creating its first patent and Gazette.

Speaker 2 Biography:

Farida Alayan – Knowledge Transfer and Partnerships Senior Specialist

Farida Alayan is an experienced professional with expertise in knowledge transfer, intellectual property, and regulatory affairs. She currently serves as a Knowledge Transfer and Partnerships Senior Specialist at the Ministry of Higher Education and Scientific Research (UAE) since October 2024, where she focuses on fostering partnerships and knowledge exchange in science, technology, and research.

Farida has over a decade of experience across various roles in intellectual property and regulatory affairs. She also works as an independent Intellectual Property and Regulatory Affairs Consultant since May 2022, offering licensing and strategic advice to clients in multiple sectors.

Previously, she held the position of Knowledge Transfer and Partnerships Senior Specialist at the Ministry of Education – UAE from November 2023 to October 2024. She also worked as an Intellectual Property & Regulatory Affairs Senior Consultant for Northumbia Pharma in the UK from December 2022 to November 2023.

Farida has held key roles in several organizations, including Axantia as an Intellectual Property Manager (2021-2022), and Pharma International Company in Jordan, where she was an Intellectual Property and Regulatory Affairs Manager (2018-2021). She also led licensing and regulatory affairs functions at The Jordanian Pharmaceutical Manufacturing Co. PLC from 2010 to 2016.

Her career is distinguished by her strong background in licensing, regulatory affairs, business development, and strategic thinking.

Farida is known for her ability to drive innovation and collaboration within regulatory frameworks, enabling organizations to maximize their intellectual property and business potential.