On-demand Webcast: Driving RI to New Levels and Moving to a Dynamic RA & QA Environment

New innovative technology regulatory intelligence (RI) tools change the way you use and see data. We have moved from a static to a dynamic regulatory environment and the right technology can help you driving RI to new levels. RI technology is creating the opportunity to enhance intelligence and insights you have never been able to collect, organize or visualize data this way before. Hear industry thought leaders provide insights on where new RI and data technology are taking the industry and how you can lead the pack.

Learning Levels: 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Learning Objectives

Upon the webcast's conclusion, you will:

  • Understand the new technology available to collect, filter and organize data for you.
  • Know new ways to manage all your organization’s data.
  • Understand how to use the next data visualization evaluation tools effectively.
  • Be able to discuss what the future holds for RI technology.

Who Should Attend

  • Specialists
  • Managers
  • Project managers
  • RA/QA and business intelligence professionals
  • Directors and vice presidents

Speakers

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 been recognized for her strategic business focus and innovative approaches to regulatory strategies and process development/improvement. Walker has worked in senior positions at Topera, Stereotaxis, Bausch & Lomb and Ethicon Endo-Surgery, a Johnson & Johnson company. Walker is a RAPS Fellow. She served as the industry representative on the medical devices dispute resolution panel and, for several years, on the RAPS Board of Directors, including the position of president. Walker is an adjunct instructor at Washington University, St. Louis.

Karen Bannick, FRAPS, principal and founder, Bannick Consulting

 Karen Bannick began her career 25 years ago as a biostatistician and database analyst at the University of Minnesota and then Medtronic. At Medtronic, she expanded into global regulatory affairs, preparing 510(k)s, PMAs and IDEs as well as EU and international submissions. Her experience includes cardiovascular, neuromodulation, incontinence, wound care, chronic pain and sleep apnea. As a biostatistician, Bannick provides added insights into potential clinical and regulatory strategies and analysis plans. In 1998, she founded Bannick Consulting, providing clinical, regulatory and statistical guidance to medical device companies. She has prepared numerous submissions and clinical reports (including CSRs, manuscripts and CERs). Bannick holds master’s degrees in health and human services administration and in management, from St. Mary’s University. She is a RAPS Fellow and president of the North Central American Medical Writers Association (AMWA) Chapter.