Searching for "quality" found 18

India In the latest blow to Indian pharma’s reputation, the European Medicines Agency (EMA) has recommended the suspension of marketing authorisations for a large number of generics tested by Indian CRO Synapse Labs. While the Indian government has taken steps to regulate the industry and improve quality, including a new Drugs,…

India The Indian pharma industry has demonstrated spectacular growth based on its strength as a global generics manufacturer. Yet Indian pharma is not merely resting on its laurels. After shining through the COVID-19 pandemic and despite recent quality issues, the country’s pharmaceutical sector is looking to refocus its efforts on innovation…

Japan Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data, say J&J’s Yumi Wakabayashi and Vicky Han in October 2023’s DIA Global Forum magazine. With appropriate efforts to ensure…

Global David H. Crean, Managing Partner for Cardiff Advisory, highlights the tone and tenor of J.P. Morgan’s recent 2023 Healthcare Conference held in San Francisco in light of the uncertain economic environment that saw fewer IPOs in 2022 than in previous years and numerous negative enterprise value companies trading below cash…

India As one of the world’s a leading pharma manufacturers, India supplies about 20 percent of the global pharmaceuticals demand in terms of volume, yet the industry remains plagued with quality compliance issues. After Sun Pharma, Aurobindo and Zydus found themselves on the FDA’s radar earlier this year, two more Indian…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

Switzerland After 15 years as director at the Friedrich Miescher Institute for Biomedical Research (FMI) (2004-2019) and even longer as the group leader at her own research lab, Professor Susan M. Gasser was appointed director of the Foundation of the Swiss Institute for Experimental Cancer (ISREC), in a way closing the…

Puerto Rico When life sciences companies decide to transfer the production of new drug to Puerto Rico, extend an existing production line, or simply sustain existing operations, they can count on the support of a vast network of service providers with unmatched expertise in quality and regulatory compliance, from premarket approval (PMA)…

Sweden Thanks to the cooperation of its citizens, Sweden boasts a comprehensive patient registry of electronic health records. Multinational pharma companies increasingly look to these registries to collect real-world evidence, which helps them develop more innovative treatments.     Combining data from the disease registry with the healthcare databases allows us…

Puerto Rico A group of industry experts who attended the Puerto Rico Manufacturers Association Convention this June 2019 have agreed that Puerto Rico should begin to place less importance on the island’s tax advantages for attracting investors. Instead, all industries on the island – especially pharmaceuticals – should focus more on sustainability…

Opinion Technology and social media has given women and oppressed minorities a platform in which to vent their frustrations regarding the prevalent inequalities that exist in our world today, and it is having an impact. However, the needle is moving slowly and the gender gap continues to cost economies billions of dollars…

Opinion Despite the disproportionately high numbers of females in the healthcare and life-sciences industries, and the fact that women are the main decision makers when it comes to family health, there is still inequality in pay and career progression. Carla Smith gives us the stats and explains why equality in the…