Medical Information
How Multilingual Medical Information Services Enhanced Patient Safety During the COVID-19 Pandemic
The COVID-19 pandemic challenged nearly every aspect of healthcare delivery—and medical information (MI) services were no exception. As patients and healthcare professionals (HCPs) urgently sought...
COVID-19 and mRNA: A Vaccine Breakthrough
COVID-19 has presented humankind with the challenges expected from a pandemic with over 700 million cases and almost 7 million deaths1. While the mRNA technology was not widely known in the news, it...
EMA COVID-19 guidance: research and development
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
EMA adopts first list of critical medicines for COVID-19
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
Regulatory Sciences
The Anniversary We Didn’t Want: One Year of COVID-19 Milestones
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global...
Now May be the Time to Approach the FDA Regarding CMC and Nonclinical Questions – Giving These Topics the Attention they Deserve
Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe. To many Sponsors, this may feel like a loss of progress...
COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials
As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations...