NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
- Hear Global VP Martin Lush’s thoughts on leadership fit for a chaotic, uncertain world and how the industry must use this crisis as an opportunity to reflect and rethink everything.
- Begin your regulatory inspection preparations now as Jim Morris highlights key areas that will warrant leadership attention to streamline pharma operations in the wake of COVID-19.
- Develop and implement changes to your risk evaluation and risk mitigation strategies (REMS) as our Amarex Clinical Research team introduce a framework of key concepts, standards and submission procedures to help you streamline this complicated FDA process.
Have you lost touch of all the essential regulatory updates due to COVID-19?
Our detailed regulatory update section has you covered. This includes all the latest U.S. and European pharma and medical device regulatory news, including ICH, updates on the EU MDR, Brexit and more. Regulatory affairs expert Marinka Tellier also reviews the U.S. regulatory preparedness in facing the COVID-19 pandemic.
We also welcome Emma Ewins to the pharma team in a virtual interview, and Na Ry Woo, a Korean Ministry of Food and Drug Safety (MFDS) Scientific Reviewer, shares her current experiences on her one-year regulatory program with Amarex Clinical Research.