Delma Lynn Broussard

Delma L. Broussard, MD is an industry leader with 20 years of professional experience in risk management of drugs/biologics, medical devices and biologic/device combination products either in Pharmacovigilance (PV) directly, or as part of Regulatory Affairs and Medical Affairs/Clinical development positions. She serves as Director, Medical Devices & Combination Products PV Expert at CSL Behring, and is responsible for leading the Medical Device & Combination Product Center of Excellence. Delma provides safety expertise to project teams and global regulatory groups for the implementation of medical device-biologic combination product regulations. She provides clinical knowledge for the creation and maintenance of design history files in collaboration with Quality and Engineering. Delma utilizes sound medical judgment for the assessment of safety signals and medical device trends, in addition to guiding the evaluations of expedited reporting and reportable malfunctions for ICSRs (across a broad range of therapeutic areas). In her prior roles, she served as subject matter expert for safety relevant discussions with global regulatory agencies to successfully gain marketing authorization approvals, negotiate label revisions and clinical study designs (including postmarketing commitments). She is an adept cross-functional navigator with a good understanding of organizations to build successful relationships with internal and external stakeholders. Earlier in her career she held senior positions at major pharmaceutical companies, including Merck and J&J. Delma holds a Doctor of Medicine degree and is board certified in pediatric gastroenterology. She is a former Associate Professor at University of Pennsylvania School of Medicine, with publications in peer reviewed journals. She is an active speaker/panelist on safety regulations for medical devices and combination products.