This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working. Here’s what you can expect from the latest edition:
- Global VP Martin Lush shares his thoughts on leadership fit for a chaotic and uncertain world, including 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 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 essential regulatory updates due to COVID-19?
Our detailed regulatory update section has you covered. It has 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 of her one-year regulatory program with Amarex Clinical Research.
Plus - learn how NSF is helping companies:
- Pivot to manufacture ventilators
- Submit emergency use authorizations for COVID-19 clinical development products
- Reopen and stay open through the ‘Checked by NSF’ program