This study is officially closed.
The purpose of this pulse survey is to examine the regulatory impact of the COVID-19 pandemic on regulatory organizations in industry. During the summer of 2020, we interviewed representative samples from both industry and provider networks to explore learning priorities and gain feedback on the study design.
A theme of organizational resiliency has emerged with the primary focused on these three areas of COVID-19 impact:
- Business Operations
- Ways of Working
- Regulatory Activities
The survey will consist of 18 to 20 questions and should take around 15 minutes to complete. Many of the questions are structured to gain insight about personal views and experiences while others explore the regulatory organizations response. We are asking for 5 to 10 individual responses per company rather than one team or consensus response from each organization. We hope a variety of regulatory roles will participate, including regulatory affairs/strategy, operations, regional/local affiliate, regulatory CMC, and regulatory intelligence/policy.
The survey will open on September 14th and close on October 31st. Study results will be available by late November 2020 to the participants and the summary study report will be placed in the public eye so that all organizations can benefit from the learnings of this research. A private debrief session will be provided for Gens & Associates Benchmark Premier members and a general community debrief session will be available for all other organizations.
If you have questions, please complete the contact form to the right or if you are ready to take the survey (closes on October 31st), please click on the blue box below. The grey boxes contain the study fast facts guide and also a PDF rendition (non-entry) of the survey to preview the questions.
We look forward to your support in this important industry research.
Questions about the COVID-19 Survey?
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
Sarah Powell of Powell Regulatory Services (supporting World Class RIM research since 2015) has over 30 years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 15 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing and review of submission content.
She has extensive experience with projects related to design and implementation of regulatory solutions (requirements definition through validation) including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent (PAREXEL). She holds a Bachelor’s of Science degree in Nutrition Science from the University of California, Davis. Sarah can be reached at spowell@powellrs.com or her company website at www.powellregulatoryservices.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