The New Common Rule: Why Industry Should Take Note
Tuesday, September 26
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET
Significant revisions to the Federal Policy for the Protection of Human Subjects known as the “Common Rule” are scheduled to become effective in January 2018. Although these changes generally apply only to federally conducted or supported human subjects research, biopharma and medical device companies should be aware of and understand the key aspects of the new Common Rule because the changes will likely indirectly impact industry studies. In the 21st Century Cures Act, Congress required the U.S. Department of Health and Human Services to harmonize differences between the Common Rule and the Food and Drug Administration (FDA) human subjects regulations applicable to most industry research by December 2019, and through the issuance of guidance FDA has already taken steps toward such harmonization. In addition, even prior to revision of the FDA regulations, the new Common Rule will become the default framework under which many institutions and other industry partners conduct human subjects research.
In this webinar, Andrew Rusczek and Emily Chi Fogler, attorneys practicing in the Biopharma and Medical Device Group and Academic and Clinical Research Group at Verrill Dana, LLP, discuss important changes to the Common Rule of which industry should take note.
Although the focus of the webinar is the new Common Rule, the presenters will also highlight various 21st Century Cures Act provisions that are also relevant to industry-institution collaborations.
In this free webinar, we will:
- Explain why the new Common Rule is noteworthy for industry
- Review the key provisions of the new Common Rule of relevance to industry, including changes related to consent and IRB review
- Discuss potential implications of these changes both now and for future potential revisions to the FDA human subjects regulations
- Biopharma and device company representatives involved in research and development activities
- Clinical research organizations (CROs) and other research-related service providers
- Institutions that engage in human subjects research subject to the Common Rule or FDA regulations
Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.