The first revisions to the Common Rule in more than a decade begin to go into effect on July 19, 2018. Institutions, IRBs, Sponsors, and Subjects are impacted by the changes. Nelson Mullins partners Carrie Hanger and Jennifer Mallory will discuss the real impact of the final common rule in 2018 during a webinar on June 21 conducted by CenterWatch/FDAnews. The webinar begins at 1:30 p.m. ET.

Hanger and Mallory will provide insight to the most recent guidance of the common rule, specifically nuanced provisions and the practical impact it has on those in the clinical trials industry. They will speak on the best practices for those in the industry and its final revisions. 

Hanger focuses her practice on advising healthcare providers and entities engaged in clinical research. Her clients range from hospitals and surgical centers to physician groups, long-term care facilities, hospices, home health providers, drug and medical device companies, and DME suppliers.

Mallory practices in the areas of FDA counseling, compliance, and clinical research and holds Graduate Certificates in Pharmaceutical and Medical Device Law and Compliance: FDA Regulation and Liability and Clinical Research and the Law from Seton Hall University School of Law. For three years, Mallory served as IRB member regarding industry-sponsored studies for the Medical University of South Carolina.  Her clients include hospitals, research centers, and drug and medical device companies.