Authors:
Sammy Sambu, Associate Director AI Solutions (UCB) / Carla Jonker, Senior Regulatory Project Leader (Dutch MEB)/ Kate Coleman, Director, Quality Management(PharmaLex) / Steve Gens, Managing Director (Gens & Associates), Klaus Menges, Regulatory Affairs and eSubmission Specialist(formerly-BfArM) / Scott Cleve, Head of Regulatory Operations (Bluebird bio) / Timm Pauli, Senior Director, Head of Global Regulatory Informatics and Operations (PharmaLex)/ Juergen Hoenig, Senior Director, Regulatory Business Intelligence (PharmaLex) / Andrew Freid
Abstract
When COVID-19 disrupted life sciences, solutions were needed in real-time. As the pandemic grew, so did the need to innovate. Workers met the challenges. They completed tasks, fulfilled inspections, and remained vigilant in fulfilling regulatory requirements. This paper presents findings from a roundtable hosted by PharmaLex. It examines how life science professionals leveraged disruptive technologies during the pandemic. In the talks, industry leaders focused on what worked well, what needs to be improved, and what comes next. The program included six topics:
• Decentralized clinical trials
• Modern data management
• Cybersecurity
• Rolling submissions
• Virtual inspections
• COVID-19 regulatory impact: What technology and business investments will be accelerated?
For life sciences, embracing disruptive technologies played a crucial role in ensuring continuity of service. Quickly adopted, disruptive technology elements became a part of day-to-day operations. Professionals adapted to work smarter, increase efficiency, and sustain quality levels. Here is a wide-ranging look at lessons learned throughout the coronavirus pandemic. Including the tools and solutions that are likely to remain in the new normal.
