PULSE STUDY SUMMARY
This research package provides the study results from our 2020 COVID-19 Regulatory Impact Pulse Survey. The study focuses on short- and long-term regulatory impact of the COVID-19 pandemic on regulatory organizations and how they are responding.
The research examines how companies are adapting to the global health crisis and evaluates practices necessary for maintaining and/or developing organizational resiliency and agility. This survey was designed to recognize diverse experiences from personal perspectives. 250+ individuals from 50+ companies participated in the study.
The pandemic is currently on-going and only time will reveal the real changes emerging out of the COVID-19 environment. As the pandemic continues to evolve, our research aims to answer the following questions:
- What will organizations learn about how they have been able to react and how will they plan out their next steps?
- What processes and priorities have been accelerated due to COVID-19?
- How will the pandemic shape the future regulatory workforce?
In this research package, you will find:
Survey Information: Survey Design Process and Participants
Executive Summary and Key Findings
- Question-by-Question Results
- Demographics
- Impact on Business
- Impact on Ways of Working
- Impact on Regulatory Activities
- Industry-derived Learning Opportunities and Practices
- Research Team Contact Information and Practice Overview
Video Recording of COVID-19 Regulatory Impact Pulse Survey Debrief
Join our Benchmark Community Distribution List
Survey Team
We have a very talented research team to support this study
Katherine Yang-Iott is a core member of the Gens and Associates team with over 15 years of experience in the healthcare and pharmaceutical industry leading and managing complex interdisciplinary projects. She worked as a research scientist at Regeneron Pharmaceuticals and The Children’s Hospital of Philadelphia before transitioning to consulting work, where she focused on strategy development, change management and continuous improvement projects to support research operations.
Katherine has a Master’s of Science in Organizational Dynamics from the University of Pennsylvania and a Bachelor’s of Science in Biochemistry. Katherine can be reached at kyang-iott@gens-associates.com.
Steve Gens is the survey co-founder with the first industry survey conducted in 2007. The 2018 World Class RIM follow-up will be the 33rd survey conducted under Steve’s leadership. He has over 30 years of business experience with the majority in the biopharmaceutical and healthcare industries. His early career was spent at Johnson and Johnson and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group.
Steve has deep experience in strategy formulation and implementation, organization development and performance, industry benchmarking, information management strategy, and facilitating strategic change. He consults for many large global biopharmaceutical companies and with small high growth organizations. He has a Master of Science in Organization Development from American University with distinction for his field work and a BS in Business Computer Science. Steve is a frequent speaker and was named as one of the 2017 PharmaVoice 100 for his contributions to industry.
Greg Brolund of Chicopee Falls Consulting (supporting survey process since 2009) is a management and technology consultant with experience with global Pharmaceutical companies in product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs and ICH eCTD, E2B and HL7 ICSR electronic submissions.
He has over 25 years of experience in all aspects of information technology including the Food and Drug Administration’s drug review process and supporting systems and as Chief Technology Officer for the US Department of Health and Human Services. He holds a Masters of Chemistry degree from the American University in Washington DC. Greg can be reached at gregbrolund@cfalls-llc.com
Kelly has 20+ years’ experience in the biopharmaceutical industry, leading IT, RIM, and Regulatory Operations organizations in several companies including Wyeth, Pfizer, Shire and Teva. She has led implementation of large-scale global systems and processes, and is passionate about the potential for pharma companies to raise the bar on productivity and compliance through process-focused management of critical data. Kelly a member of the EMA SPOR Task Force and its PMS subteam, is a member of ISO TC/215, and is also Vice President of IRISS (www.iriss-forum.org).
Kelly has expertise in the structure and function of global regulatory organizations from both an organizational/business process and a systems/data perspective, and founded K2 Consulting (www.k2rim.com) in 2018 to support global regulatory organizations in identifying, defining and implementing the most effective processes and capabilities for their specific situations and needs. Kelly can be reached at kelly.hnat@k2rim.com