Study Introduction
A key objective of most Life Science companies is improving the global management of key regulatory information. The combination of process optimization, effective global systems, high data quality, and enhanced affiliate collaboration are required to realize Regulatory excellence.
The primary study goal is to understand how core regulatory information is created, managed, consumed, and archived to support Regulatory activities from the Affiliate perspective. The survey covers specific activities in managing Submission Forecast and Planning, Product Registration Management, Health Authority Commitment Management, Health Authority Interactions Management, Local Label Management, Submission Content Management, Submission Archiving, Regulatory Intelligence Management, and Promotional Material through the use of systems and tools.
Key Learning Priorities include:
- Understanding the affiliates’ perspective on how they can be better supported within their functions
- Identifying key barriers for collaboration and engagement with headquarters
- Exploring opportunities to improve process and system efficiencies
STUDY FAST FACTS
- We expect between 18-22 companies or 300 + local affiliate offices to participate
- Study opens on May 9th, 2023 and closes on Friday July 21st, 2023
- All participants should be enrolled by the end of May 2023 to give proper preparation time
- A Study Guide and Entry Videos are available to support participating organizations
- Full research results, study report, and debriefs targeted for late September
- There is no cost to participate, study is blinded, participants receive full results and peer comparison
The following videos are intended for those companies actively participating in the study.
Study Introduction and Demographic Questions
Affiliate Study Questions 7 to 17
Affiliate Study Questions 8 to 26
To enroll in the study or request further information, fill out the form below.
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