Tagged with B

Saudi Arabia Professor Khaled Al-Kattan, dean of Alfaisal University’s College of Medicine, explains how Alfaisal University is deeply integrated into Saudi Arabia’s Vision 2030, focusing on transforming education and healthcare. The university has embraced a model that prioritizes research and development, collaborating with government initiatives to produce graduates who are well-prepared to contribute…

Saudi Arabia As life expectancy increases, how do we ensure that quality of life does too? That is the conundrum that Saudi Arabia’s Hevolution Foundation was set up to help solve. Hevolution invests in extending the healthy human lifespan across the world through research and treatments which target age-related diseases and conditions.…

Saudi Arabia As a part of the sweeping transformation Saudi Arabia is achieving thanks to its Vision 2030, the Kingdom is also advancing its research ambitions. With the restructuring of its regulatory framework along with its well-established network of research institutes and bolstered by the integration of electronic health records, Saudi has…

Global Brendan Shaw paints a concerning picture of global health priorities post-pandemic, highlighting the need for renewed focus and investment in healthcare systems to prevent further backsliding.   “There isn’t a financing gap. There is just money that is not moving towards the right things. There’s plenty of money out there”…

Saudi Arabia PwC veteran of 20 years and partner in the consulting firm’s strategy arm, Strategy&, Dr Walid Tohme has been directly involved in Saudi Arabia’s healthcare transformation journey since 2016. He discusses the significant progress that has been made since then, including the institutional restructuring to separate regulatory functions from healthcare…

Saudi Arabia Faisal Al Tlasi introduces Axantia’s strategic goals, the transformation of Saudi Arabia’s healthcare system, and the company’s role in supporting Vision 2030. He discusses the importance of expanding the company’s product portfolio, entering new markets, and enhancing employee capabilities. Emphasizing partnerships and regulatory advancements, Al Tlasi underscores Axantia’s commitment to…

Saudi Arabia Dr Eid Mansour, general manager of Gilead’s new Saudi affiliate, shares the strategic goals behind the creation of a strong direct presence in a region previously managed almost entirely through distributors and how these goals align with the kingdom’s Vision 2030 and the National Transformation Programme. He also outlines the…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies: the Agency for Medicines and Medical Devices (ALIMS), which is an independent regulatory body entrusted with…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical trials are funded by the sponsors.…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? As outlined in the answer to question 3 in Chapter 1, marketing authorisation of medicinal products (including new drugs and biologics, regardless of the manner of reimbursement) may be…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are subject to a marketing authorization issued by ALIMS. Marketing authorization is not required for traditional herbal medicines or homoeopathic medicines which fulfil conditions prescribed in the Medicines Act. Instead, they are registered…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In Serbia, there are two parallel regimes of product of liability applicable to medicinal products. The first one is established by the Obligations Act of 1978 (as amended), while the second type is prescribed by the Consumer Protection Act of…