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Veristat’s Science Advisory Board met on 14 March 2023 to discuss Executing Patient-Focused Drug Development (PFDD), with a focus on the application in rare diseases.
Patient health and wellness extend beyond biology and symptoms of disease, encompassing...
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In the world of biotechnology, where groundbreaking discoveries have the potential to change lives, adaptability and flexibility are paramount. Clinical operations can be a complex web of challenges, especially when dealing with rare diseases and gene...
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In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to regulatory compliance. The FDA approval process has become significantly streamlined with the introduction of electronic record...
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Veristat, in partnership with TOPRA, recently hosted an insightful webinar titled "Future Trends on European Regulations on Medicines." This webinar provided valuable updates on the new Pharmaceutical Strategy for Europe and its impact on the regulatory...
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Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU)
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Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process for medicinal products in Europe. Learn how RWE is reshaping the development landscape, its potential benefits, and the challenges associated with its...
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Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman.The goal of the initiative is to educate, innovate, and collaborate with the oncology community- including companies, academia,...
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For the past 60 years, US law has empowered the FDA to require that clinical trial sponsors submit data from “preclinical tests ” to prove their drug is safe enough to advance to testing in humans. At the close of last year, Food and Drug Omnibus Reform...