Speakers

CDR Silvia Wanis is a Senior Regulatory Officer with CDER’s Office of Drug Security Integrity and Response (ODSIR) since March 2019, and brings over 20 years of experience as a PharmD. In her current role, she coordinates regulatory compliance efforts to enhance drug safety and security, ensuring swift action to meet statutory and regulatory standards. She also addresses supply chain disruptions and drug shortages of essential and lifesaving medicines.

She joined the FDA in 2010 as a Consumer Safety Officer and has since worked in various roles, including CDER’s Office of Compliance, Office of Prescription Drug Promotion and CBER’s Office of Manufacturing and Product Quality. Prior to joining the FDA, CDR Wanis was a pediatric pharmacist at the University of Chicago Children’s Hospital. She is a Board-Certified Pediatric Pharmacotherapy Specialist with a Master’s in Executive Leadership and earned her PharmD from the University of Illinois at Chicago (UIC) in 2000.