Regulatory Challenges in the COVID Era

The online event was part of the 3rd edition of the international conference Biotech Atelier 2020

 

The specialists from PharmaLex Bulgaria have recently organized an online session dedicated to the regulatory challenges we are facing during the COVID era. The event was part of the European biotechnology conference – Biotech Atelier 2020 that brings together recognized scientists, business leaders, international experts in the field of Biotechnology, Healthcare, Life Sciences, Pharma and Information, and Computer Technologies.

During the session “Regulatory challenges in the COVID era”, experts discussed the new challenges and opportunities in our industry emerging during the COVID-19 times.

Diego Zalava, the Regional Senior Manager LATAM, PharmaLex was the first speaker of the online event. He gave an overview about Regulatory measures during COVID-19, focusing on the specific actions taken by countries around the world in order to avoid shortages during the outbreak, as well as the key challenges and temporary solutions that have been established.

According to him, the major challenge during the lockdown period is to keep the business running, especially with regard to non-COVID related submissions. He pointed out that even now when the priority is on COVID-19, it is very important that companies and institutions maintain balance and do not neglect other submissions.

During the discussion Hrabrina Hristova, Head of Regulatory Affairs, PharmaLex Bulgaria highlighted that one of the main challenges for Bulgaria was the need for digitalization of processes.

“The pandemic crisis somehow impacted the authorities to quickly adapt to new techniques and technologies and to enable e-signatures or e-submissions in order to handle the situation.”- she said.

In the second part of the webinar, Dr. Autumn Dawn Lang, Co-Founder & CEO, Confinis AG, talked about the clinical regulatory challenges that arouse during the COVID-19 Era. As being involved in different clinical affairs, she highlighted that changes were mostly seen in two specific areas – disruption in Clinical Investigation and in the History of Framework, because of slow evolution.

She also mentioned that more than 950 organizations reported specific disrupted investigations in the public domain (50% US), and the most common disruptions were Enrollment Suspension, Slow Enrollment and Delayed Initiation. In order to deal with the disruption, professionals were forced to adapt fast and develop contingency plans.

At the end of the event, the presenters came to the conclusion that during a time of crisis, it is important to simplify procedures as much as possible, minimize non-value adding activities, and to focus on the most critical tasks.

The main goal of the session was to connect experts in order to exchange and generate new ideas for innovation, entrepreneurship, and business development.

If you would like to learn more about the topics of the event, you can watch the full YouTube Video here: https://bit.ly/2IqsFyv