The emerging field of regulatory intelligence (RI) has such tremendous capacity to inform the regulatory process, it should be an essential component of every regulatory professional’s toolbox. This webcast will explore the types of publicly available information and demonstrate how they can be assessed and utilized to improve outcomes in many arenas, including:
- product submissions and reviews
- monitoring, predicting and influencing the regulatory landscape
- helping guide strategic business initiatives and objectives
Learning Level(s): Basic & Intermediate
Upon the webcast's conclusion, you will be able to:
- understand the art and science behind RI and why RI is vital to your success and your organization
- learn where and how to find the information and the limitations of available information
- integrate and apply RI to your daily practices
- apply time-saving tools to help manage the abundance of available RI data
- identify how RI fits into your overall regulatory strategy and business objectives
- understand where RI is headed
Who Should Attend?
- Regulatory and quality assurance senior management
- Regulatory and quality assurance directors and managers
- Regulatory and quality assurance specialists and project managers
Melissa Walker, MS, RAC, FRAPS, president and CTO, Graematter
Melissa Walker has more than 28 years of experience in regulatory, clinical and quality systems. She has worked in senior positions at Topera, Stereotaxis, Bausch & Lomb and Ethicon Endo-Surgery, a Johnson & Johnson company. Currently, Walker is the president & CTO of Graematter Inc., a regulatory intelligence firm focused on the medical product industry. She is also a RAPS Fellow. Walker served as the industry representative on the Medical Devices Dispute Resolution Panel and for several years on the RAPS Board of Directors as President and Chairman. Walker is an adjunct instructor at Washington University, St. Louis.
Wendy Saub, president, Regulatory Archetypes, LLC
Wendy Sauber is president of Regulatory Archetypes, consulting on prescription and OTC medicines, medical devices and IVDs. She provides services in strategy development, submission preparation, FDA meeting preparation, coaching and mentoring, organizational development, comprehensive due diligence assessments and product liability support. Previously, Sauber was the head of global regulatory affairs, clinical & compliance for Life Technologies Corporation (Thermo Fisher Scientific). Sauber entered the corporate world in Ethicon Endo-Surgery (ESS), a J&J company where she started the clinical-technical customer service business at EES, and managed products liability cases. Prior to corporate, she was an RN and head of cardiothoracic and vascular surgery and the Heart Transplant Surgical Unit at Seton Medical Center. Sauber holds a BSN from the University of Cincinnati and an RN from Charity Hospital School of Nursing.