Presenters
Jason Cober, MPA
Lead Project Manager, OPDP | OMP | CDER | FDA, United States
Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 15 years experience with the Agency's eCTD specification and guidance development process.
Josephine Secnik, MBA, MS
Director – Ad/Promo Regulatory Affairs, Eli Lilly and Company, United States
Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes 10 years in global CMC and for the last 8 years supporting the US business on advertising and promotion for marketed products.
Joanne Hathaway
Senior Manager, Promotion Compliance, Otsuka Pharmaceutical Commercialization & Development, United States
Joanne Hathaway joined Otsuka Development & Commercialization (OPDC) as Senior Analyst, Document Management in 2016. In this role, she was responsible for managing promotional materials for all marketed products that required submission to the Office of Prescription Drug Promotion (OPDP) on Form FDA 2253. Joanne took on the challenge of preparing for electronic submission of promotional materials to OPDP through the electronic gateway (eCTD), and was promoted to Manager, Promotion Compliance. Joanne received an Associate of Applied Science degree in Business from Union County College, Cranford, NJ, and a Bachelor of Science degree in Business Management from Kean University, Union, NJ.
Riley Stelzer, PharmD
Senior Manager, Regulatory Affairs Advertising and Promotion, Neurocrine Biosciences, United States
Suzanne Libby, MS
Associate Director, Regulatory Affairs Advertising Promotion , Takeda Pharmaceutical Company Limited, United States
Have an account?