On-Demand Webinar

Decentralized Clinical Trials Involving Biologics: Unique Challenges

Decentralized clinical trial (DCT) modalities continue to transform the way we conduct clinical research. One surprising area: studies involving genetically modified biologics.

In this webinar, you’ll find out what FDA says about DCTs and biologics, and what this means in practice. Dr. Daniel Eisenman provides a biosafety perspective on these types of studies, explaining the unique risks and important considerations for ensuring safe, responsible trial conduct.

Learning Objectives:

  • Describe key ways biologics research differs from small molecule research
  • Summarize what FDA guidance says about DCTs involving biologics
  • Discuss ways to address the unique challenge of biologics in DCTs

Presented By

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Daniel Eisenman

PhD, RBP, SM(NRCM), CBSP

Executive Director, Biosafety Services
Advarra

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Meagan Vaughn

PhD, RAC

Associate Clinical Director, Clinical Development
Krystal Biotech

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Jennifer Abeles

DO

Assistant Clinical Professor, Internal Medicine and Pediatrics
Conventus Site Medical Director for UBMD

Adult Transitional Sickle Cell Program Director Department of Medicine
Jacobs School of Medicine and Biomedical Sciences University of Buffalo

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Who should watch?

Research professionals from sponsors, CROs, and sites involved in the development and conduct of clinical trials with DCT elements, especially those involving biologics (e.g., rare disease studies).

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now