Regulatory Director
Hogan Lovells LLP
W. Alex Smith is a software engineer working for the law firm of Hogan Lovells LLP in Washington DC. Alex's practice involves submitting CDRH and CBER submissions that include a software components and algorithms. On average, Alex prepares and submits at least 3-5 FDA submissions for clients per week. Accordingly, Alex can provide insight into the level of detail to provide FDA in regards to software, cybersecurity, and OTS information for an efficient submission package. Prior to Sidley Austin, Alex worked for Sidley Austin LLP as a submissions expert, GlaxoSmithKline as a Drug Manufacturing Process Control Manager, and for several years at Human Genome Sciences as an application engineer. Alex holds degrees in computer engineering and business, as well as certifications for RAC and Microsoft Server Engineering
Disclosure information not submitted.
Monday, September 12, 2022
4:35 PM – 5:30 PM MST