Many might say good riddance to 2020, a year riddled with social isolation, economic crisis, and global health threats, and we at IVT Network concur. Yet, as we look back at this extremely unprecedented year, we cannot help but recall some of the more positive elements that lead to knowledge and growth in 2021.
One of the first lessons we learned at the onset of the pandemic was how to thrive in a digital space. As global lockdowns demanded work from home practices by all but essential workers, we saw new laws around personnel safety and social distancing, as reported in COVID-19 Personnel and Safety Issues. As the country began to fully embrace social distancing and a new way of communicating amongst colleagues many switched to zoom meetings, virtual happy hours, expanded LinkedIn networking and learning, as well as a dramatic increase in the posting of “pet” assistants.
Of course, many other necessary functions were also going virtual such as regulatory audits, which was discussed in an April episode of Voices in Validation. Virtual Audits During COVID-19 and Beyond, is an episode that still holds relevance today. With increased internet traffic, and more vulnerable data being accessed remotely, cybersecurity very quickly became a burning topic across the industry, and was addressed in the Voices in Validation episode Managing Data Integrity in the GCP Environment.
If you were one of the thousands of Americans hunting regularly for hand sanitizer and toilet paper, you understand the shortages we faced all too well. Understanding just where the gaps are in the supply chains and how to circumvent a repeat of this in the future is the key lesson here. We had a very insightful discussion on Supply Chain Management During Times of Uncertainty. Much later the FDA began working on mandatory reporting guidelines for critical drugs and APIs, in an attempt to catalogue and track resources necessary for manufacturing drugs essential to patients. These changes are evolving and will likely have far-reaching impacts long into 2021 and beyond.
As the summer turned into autumn, and the Emergency Use Authorizations continued to mount, industry experts continued to research the impacts unfolding as a result of the virus and the resulting economic, social and scientific disruptions. A few articles of note include: COVID-19 And The Need For Robust Risk Control Strategies – Can ICH-Q9 Help?; Reusable Gowning In Viral Vector Services; The Regulatory Affairs Management In Smart-Working: From The Lockdown Experience To Possible Future Scenarios; and Restarting Your Facility – When Disaster Strikes.
The best news of 2020 came in early November when we heard of the Pfizer and BioNTech’s vaccine effectiveness. The drug was approved in December under an EUA, followed quckly by the approval of a similar vaccine by Moderna. While most of us will have to wait until later this year for our chance to receive one of the many vaccines which will be available in coming weeks, at least we can do so with renewed hope for recovering global health, rehabilitated economic opportunities, and transformed social interactions.
Happy New Year!
The IVT Network Team