The September public meeting for the Life Sciences Project Management group (LSPM) will take place in Indianapolis on Tuesday, September 28 at Franklin University of Ohio. Franklin University of Ohio is located on the northeast side of Indy at 8415 Allison Pointe Blvd â€“ zip code 46250.
“Leveraging Project Management Skills as a Pharma US Regulatory Coordinator”
Presenter: Jody Roth, Principal Advisor- US Regulatory, MS, PMP, RAC, Eli Lilly and Company
Synopsis: “Developing innovative new drugs for approval requires knowing and using Project Management skills and tools. This skill set is critical for a Regulatory Coordinator who must lead an internal project team to implement a regulatory strategy and interact, negotiate and influence the FDA in order to gain final approval. Please join us as Ms. Jody Roth discusses how a Regulatory Coordinator adopts and implements elements of the PMBOK during drug development.”
Jody Roth is a Principal Advisor in Regulatory, a PMP and has her Regulatory Affairs Certification (RAC). She has more than 7+ years experience in US Regulatory Affairs processes leading internal teams and interacting with FDA reviewers and project managers.