Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2 Diabetes. Throughout the industrialized world today, the most common cause of chronic liver disease is Non-Alcoholic Fatty […]
The regulatory landscape has changed drastically over the last few weeks, and we are left wondering how society might change as a result of COVID-19. Check out our webcast, sponsored through Regulatory Affairs Professionals Society (RAPS) and featuring YourEncore Regulatory subject matter experts Joseph Lamendola, Graham Higson, and Steve Pondell, as we discuss current hot topics and emerging challenges affecting regulatory affairs professionals globally.
Understanding these terms to pursue your investigational research and the timing of when to partner with the FDA are an important part of navigating the regulatory pathway.
The introduction of new EU MDR regulations brings updated requirements and challenges to device manufacturers. Read more from YourEncore Expert Judith Meritz on the future of EU MDR Regulations..
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 2 of her Expert Q&A.
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 1 of her Expert Q&A.
In this Expert Q&A session, Luann Van Campen, Ph.D., M.A., and Don Therasse, M.D., provide valuable insights into the implementation of bioethics best practices within life sciences organizations.
According to a study from Deloitte, it is estimated that bringing a new drug to market can cost almost $2 billion (as of 2018). While the costs to develop assets are rising, the value per asset continues to decline with pricing pressures coming from every direction and increased competition in the market from expiring patents […]
Raphael G. Ognar discusses the overlying challenges biopharma organizations have and how Virtual Development can save the day.
Joseph Lamendola, PhD discusses the challenges many biopharma companies face and how Virtual Development can help create solutions.