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A Regulatory Push for Innovation: Understanding Clinical Trial Regulatory Shifts – And How to Succeed


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Webinar Notes

From the FDA to EMA and beyond, regulatory authorities worldwide are modernizing guidelines to foster innovation and patient-centricity in clinical trials. Behind this modernization are the dual intentions of eliminating hurdles to innovation and ensuring that clinical trial regulations are optimally designed to minimize risk to patients. Together, the changes regulators are making aim to accelerate the development of safe and effective drugs and devices.

As organizations adapt to these regulatory changes, what’s the role of clinical trial technology? Join Katie Kahn of Medrio for a discussion of how researchers can leverage their eClinical resources to reach the level of flexibility and efficiency that a rapidly shifting regulatory environment demands.

Key takeaways:

  • Learn what changes to the 510(k) pathway and the push for real-world evidence mean for device research
  • See how a regulatory push for novel trial designs promotes success in oncology trials
  • Get updates on developments in European regulations, such as the EMA’s draft opinion on eSource

Webinar Hosts

Katie Kahn

Product Marketing Manager, Medrio

Katie Kahn joined Medrio in 2015 bringing years of clinical trial experience. She is an expert in eClinical technology and the regulatory landscape affecting various industries in clinical research. Katie holds a B.Sc. from Keck School of Medicine at the University of Southern California, and is a proud San Franciscan.