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概述

Jenny Stohlmann is an RAC-certified regulatory specialist whose expertise spans the complete product life cycle for prescription and over-the-counter human and animal drugs, biologics and medical devices. She possesses deep knowledge of the latest FDA and FTC guidelines across a wide range of industry-critical issues, and she has performed extensive analyses of FDA, OIG and DOJ enforcement activity related to the commercialization of FDA-regulated products. 

Jenny works with organizations to foster a culture of compliance that incorporates formal programs and translates them to compliant daily activities. Her experience ranges from detailed legal research and drafting of policies to operations and systems implementation in the live business environment. 

She performs compliance management of commercial system vendors and 3PLs and participates on commercial product launch teams. In addition, Jenny crafts compliance trainings for clients’ home office personnel, field forces and vendors on topics ranging from prescription drug sampling to speaker programs to medical communications. 

Over the course of her career, Jenny has demonstrated knowledge of the regulatory and compliance obligations of manufacturers and distributors under FDCA, PDMA, User Fee Acts, FDAMA, FDAAA, FDASIA, PPACA and Title 21 of the Code of Federal Regulations.

教育背景

  • Regulatory Affairs Certification Board, Regulatory Affairs Certification (United States)
  • Regulatory Affairs Professional Society, Regulatory Affairs Certificate Program, Medical Devices and Pharmaceuticals (Dual)
  • Pratt Institute, B.F.A. in Writing
  • President's List, Department Honor for Academic Excellence

联系

  • Member, Regulatory Affairs Professional Society