On-Demand Webinar

Creating an Integrated Approach to Regulatory Management at Your Institution

Over the past year, clinical research professionals have faced unprecedented challenges related to both the clinical and operational management of their research. Maintaining regulatory compliance and visibility within an increasingly remote environment has been a key focus area for many institutions. Using new technologies to enable these remote functions while learning and adopting new FDA guidance came with a steep learning curve. While the industry has done remarkable work to address these challenges and keep research moving, organizations now need to step back and re-evaluate the regulatory solutions they’ve put in place throughout the year.

As we continue to navigate the new research landscape, many institutions have found that integrations can play a key role in improving regulatory compliance and increasing efficiency. In this webinar, we’ll explore key integrations throughout the regulatory management process—both technology-driven and process-driven—to help reduce the regulatory burden at your institution.

Learning Objectives:

  • Identify key areas within your regulatory management workflows that can benefit from integration and centralization
  • Learn how implementing and integrating an eRegulatory management system can improve compliance and productivity, and reduce cost
  • Understand how to assess what regulatory requirements apply to remote work enabling software for clinical research

Presented By

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Wendy Tate

PhD, MS, GStat

Director of Research Operations
Advarra

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Stuart Cotter

Director of Product Management
Advarra

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Stuart Cotter

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Director of Product Management
Advarra

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Who should watch?

Research professionals at academic medical centers, cancer centers, and health systems. This content applies to operational staff responsible for enterprise technology, as well as roles related to regulatory and data management such as Regulatory Manager, Regulatory Coordinator, Data Manager, and CRA.

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

Provider approved by the California Board of Registered Nursing, Provider Number 16549, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.

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.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education 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: January 21, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now