IRB & ICF Approval Simplified: 5 Key Considerations and Mistakes

Advancing institutional review board (IRB) and informed consent form (ICF) approval isn’t a matter of chance; it’s often the result of planning, precision and partnership. This webinar brings together leaders from both the IRB and pharmaceutical sponsor perspectives to discuss what truly drives smoother, faster and more compliant approvals.

In this practical discussion, the featured speakers will share lessons learned from hundreds of submissions and real-world examples of what can make or break ethics reviews, particularly around submission and the ICF process. Attendees will walk away with a sharper understanding of both the science and the art behind successful IRB engagements.

Those who have experienced the frustration of multiple rounds of IRB revisions, or the anxiety of looming trial start dates, will find this webinar valuable in demystifying what IRBs prioritize and how sponsors can meet those expectations without losing agility.

Whether responsible for protocol authorship, regulatory submissions or patient-facing materials, this session will sharpen participants’ ability to anticipate concerns and present submissions that pass the first time.

Register for this webinar to learn practical strategies for achieving faster, compliant IRB approval.

Speakers

Mary Ann Aron, Director, Clinical Site Operations, Pfizer

Mary Ann Aron, an experienced RN, MSN and CNS, serves as the Director of Site Management and Monitoring, USA, within the Global Site & Study Operations at Pfizer Research & Development from 2015 to 2025. In this role, she ensures that appropriate Site Care Partners are in place to efficiently deliver on study and site-level start-up activities, aligned with study milestones and strategically coordinates cross-functionally with teams in SSU, Study Optimization and Study Management, providing valuable input into country and site selection. Mary Ann also serves as the Operational Manager of the Pfizer Central ICD Process TEAM and the Vendor Lead for Commercial IRBs at Pfizer. She holds a BS in Nursing from The University of Maryland and an MS in Nursing from Rutgers University.

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Ali Griffin, Site Relationship Partner, Pfizer

Ali Griffin, MS, BSN, has over 25 years of experience in the clinical research industry, including roles as a Research Assistant, Study Coordinator, Senior Clinical Research Associate and Regulatory Specialist. Ali has been with Pfizer since March 2021 and currently serves as a Site Care Partner II and Line Manager for the Central ICD Processing Team within Global Site & Study Operations at Pfizer Research & Development, a group she joined at its inception in May 2023. She holds a BS in Nursing from the American International College and an MS in Clinical Research Management-Regulatory Sciences from Arizona State University.

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Dawn Pope, Chief Operating Officer, Sabai

Dawn Pope is a clinical research professional with over 20 years of experience in protecting research participants. As a purpose-driven leader, she has spent her career building high-functioning teams, implementing strategic plans to elevate organizational performance and delivering innovative solutions to strengthen client relationships. She has extensive experience in operations, client relations, continuous improvement methodologies and regulatory compliance. She is passionate about operational efficiencies that help bring new therapies to patients sooner. Dawn earned her Bachelor’s degree in English from Campbell University in North Carolina.

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Melissa Fink, MA, CIP, Senior Director, IRB Services, Sabai

Melissa Fink, MA, CIP, is a Certified IRB Professional with over 20 years of IRB administration and IRB member experience in academic and central IRB settings. She has served as a PRIM&R mentor, on NIH/Foundation grant Advisory Boards, AAHRPP working groups and has consulted, published and presented in various areas of IRB Operations best practices and clinical research compliance. Prior to joining Sabai, Melissa served as the IRB Director at an academic medical center IRB. She has extensive insight into institutional IRBs, IRB reliance agreements and Single IRB Use. Melissa is a solutions-oriented, outcomes-driven servant leader who is passionate about Sabai’s people-first culture. Melissa earned her Bachelor’s degree from the University of Dayton and her Master’s degree from St. Louis University.

 

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