Tagged with DIA

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

India Regular contributor Brendan Shaw gives his informed take on how best international stakeholders can engage with India’s attempts to transform into a global pharma innovation powerhouse,   Our greatest ability as humans is not to change the world, but to change ourselves Mahatma Gandhi The secret to success in India…

India Dr Santosh Indraksha serves as Deputy Drugs Controller (India) for the Central Drugs Standard Control Organisation (CDSCO) under the Indian Ministry of Health and Family Welfare. As a representative of India’s main regulatory body for pharmaceuticals, tasked with overseeing the organisation’s international cell, Dr Indraksha outlines the key upgrades in…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, Scott P. Commins of the University of North Carolina School of Medicine, Jasmine Uchi of VeganMed, and Sachin A. Shah of the University of the Pacific address the use of animal-derived ingredients (ADIs) in pharma and outline a…

India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…

Portugal Diabetes is a rising threat to the Portuguese people, the country’s healthcare system, and its economy. Portugal’s National Diabetes Observatory observed that 1.1 million Portuguese people between the ages of 20 and 79.5 (out of a total population of just 10.3 million) were living with diabetes in 2021.   This…

India Dr Viranchi Shah of Saga Lifesciences and the Indian Drug Manufacturers Association (IDMA) outlines the Indian pharmaceutical industry’s potential for growth and its role in global health initiatives. He highlights IDMA’s focus on scaling operations, affordability, accessibility, quality, and compliance to drive positive change across the sector. Dr Shah also…

Portugal Novo Nordisk’s spectacular ascendancy in 2023 has meant that its country managers across the world have had to embrace scrutiny and press coverage like never before.   In its centenary year, the Danish firm’s new generation of obesity drugs supercharged revenues to around EUR 30 billion, a 30 percent hike…

India Drawing on a unique background in both medicine and law, Dr Milind Antani today leads the pharma and healthcare practice at Nishith Desai Associates, covering everything from regulatory work to corporate transactions, intellectual property matters, and dispute resolution. Dr Antani highlights the dynamic M&A landscape in Indian healthcare and pharmaceuticals…

India J&J India’s Jayashri Kulkarni lays out her approach to comprehensive leadership, drawing on her diverse career history across various sectors; her mandate to leverage innovative assets to transform disease management in India; and the importance of actively championing diversity, equity, and inclusion (DEI) within the company, building a future-fit organization…

India Shailesh Siroya explains the rationale behind Bal Pharma’s strategic focus on niche products within the API segment, avoiding the broader, more competitive commodity markets and enabling it to establish a significant global presence. Siroya also outlines how Bal Pharma has evolved from its initial focus on the export market to…