Tagged with R

Saudi Arabia Dr Adel AlMarshad, MD MPH serves as General Supervisor for the Health and Biotechnology Sectors at the Royal Commission for Riyadh City (RCRC) as well as Executive Director of Riyadh Megaprojects in Health, Biotechnology, and Medical Tourism. Dr. El Marshad discusses the RCRC’s pivotal role in transforming Riyadh into a global…

Germany Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. looks out over the choppy waters for life sciences venture capitalists in Europe over 2025. Three key initiatives stand to reshape the continent’s investment climate, but broader geopolitical winds – especially those now emanating from the White House – could…

Europe Dr Carolyn H. Rogers, Rushikesh S. Dasoondi and Dr Michael A. Roberts from UK and European intellectual property law firm Reddie & Grose LLP examine the intersection of personalised medicine and rare diseases and its implications for IP law.   Personalised medicine, also referred to as precision medicine, is an…

Europe Will a new ‘Critical Medicines Act’ go far enough to ensure Europe’s resilience to future health crises?   A Continent at Risk The COVID-19 pandemic exposed serious vulnerabilities in the European medicine supply chain. EU countries suddenly found themselves competing for limited supplies of sedatives and antibiotics for ICU care,…

Saudi Arabia Daniel Vella Friggieri, Regional CEO for Europe and the Middle East at Aspen Pharmacare, discusses the company’s growth trajectory over the past 18 months, highlighting the decision to merge the Middle East and European regions into one unit. He reflects on Aspen’s evolving approach in Saudi Arabia, covering localization, talent…

MEA Mohammad El Khoury, General Manager of GE HealthCare in Saudi Arabia, explores the company’s evolution—from adopting direct distribution models to pioneering AI-powered diagnostics—while aligning with Vision 2030. By forging strategic public–private partnerships, enhancing training programs, and fostering a culture of accountability and innovation, GE HealthCare is contributing to reshape the…

Puerto Rico CDI Labs, founded in 2008 in Mayagüez, Puerto Rico, is a specialized CRO focused on drug development and clinical-stage research, particularly in antibody specificity, biomarker exploration, with emphasis on autoimmune diseases and immunoncology. CDI is leveraging proprietary technologies like its “human on a chip” system to analyze protein interactions and…

Asia A whistlestop tour though the latest news from pharma in Asia, taking in the American gene sequencing giant caught in the crosshairs of the US-China tariff row, the ADC-focused Singaporean biotech getting a 187 million dollar funding boost, why the Australian regulator has rejected Eisai’s Alzheimer’s drug, the activist fund…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and the National Health Insurance House (http://www.cnas.ro/).   2. What is…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.  …

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and…