Getting Real About Real World Evidence
Practical Next Steps for Drug and Device Manufacturers

NOTE: This webinar has been postponed. Please check back for further updates.

Real world evidence — “RWE,” so-called — is making its way into your world.

FDA regulation and inspections are being affected in ways large and small. Meanwhile, some bold drug and device makers are finding ways to take business advantage of the opportunities RWE offers, while others hang back, worried about risks and unforeseen consequences.

In other words, it’s kind of a mess.

Or, put more kindly, a rapidly developing situation with both regulatory and profit impact that’s certain to affect ... you.

FDAnews has reached out to Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, to walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. In this fast-paced 90-minute webinar, you’ll discover:

  • Ways drugmakers are using RWE to support promotional claims
  • Ways devicemakers are using RWE to support premarket applications
  • Why some manufacturers hesitate to use RWE for promotional claims, fearing charges of unsubstantiated claims, increased legal liability, and increased government surveillance
  • Impact of recent FDA statements: How the agency may want RWE data included in approval and clearance applications, and as a basis for drug and device promotional claims
  • Interpreting FDA guidances: How the agency may use data collected outside of the traditional clinical-trial context to support regulatory decision-making; how RWE “could constitute valid scientific evidence that could be used in some FDA regulatory contexts”
  • The 21st Century Cures Act: How it seeks to speed drug and device approval by shifting certain evidentiary requirements from clinical trials to post-market—in other words, to “the real world.”
  • And much more!

RWE is real and it’s here to stay. Going forward, you can expect it to move the FDA in new directions, and to affect your business decisions in unanticipated ways. Now is the time to learn what you need to know to stay compliant ... and competitive. Register now.

Who Will Benefit

Real world evidence (RWE) affects FDA health regulation across the board – devicemakers, drugmakers, biotech, and consultants to these industries that conduct studies or analyses with RWE. This learning session will be of particular interest to:

  • Regulatory specialists
  • Quality specialists
  • Strategic planners
  • Clinical trial developers
  • Data Analysts


Meet Your Presenters

Sonali P. Gunawardhana Esq.

Of Counsel
Wiley Rein LLP

Sonali P. Gunawardhana Esq., Of Counsel, Wiley Rein LLP, draws on early 10 years’ experience as an FDA lawyer to offer clients practical, forward-looking guidance on avoiding and resolving FDA regulatory challenges. At the FDA she worked closely with district-office investigators inspecting devicemakers, IRBs, clinical investigators and CROs. Her civilian practice expertise includes current Good Manufacturing Practices (cGMP); clinical trial compliance strategies; and programs that FDA field investigators use during inspections.

Vini Doraiswamy, PhD

Senior Vice President of Clinical, Regulatory, and Scientific Affairs

Vini Doraiswamy, Ph.D. joined AtriCure in March of 2017. Prior to joining AtriCure, he served as Vice President of Global Clinical Operations at St. Jude Medical overseeing clinical operations for over 100 clinical trials worldwide and managed a team of over 300 people. He spent a large portion of his career in the Afib market and served in various leadership capacities, including program management, clinical affairs, strategic planning, and portfolio management. Before St. Jude Medical, Dr. Doraiswamy’s held several positions of increasing responsibility in marketing, field clinical engineering, IDE and post market clinical studies at Boston Scientific, Guidant Corporation, and Promega Corporation. Dr. Doraiswamy received his Ph.D. from North Dakota State University.

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