FDA's DDMAC Compliance: Current Issues and Emerging Perspectives

Instructor: Janet Rose Rea
Product ID: 702124
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This DDMAC Compliance training will cover regulations, their application and enforcement activities as they relate to FDA’s Division of Drug Marketing, Advertising and Communications.

Course "FDA's DDMAC Compliance: Current Issues and Emerging Perspectives" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

This course provides a survey of the regulations, their application and enforcement activities as they relate to FDA’s Division of Drug Marketing, Advertising and Communications. With that background, we will explore current issues in drug product promotion, including web-based activities.

By the end of this webinar, the participant will have a basic understanding of vocabulary and the context by which the Division of Drug Marketing and Advertising (DDMAC) reviews and evaluates information that can be “promotional” in nature. The role of DDMAC has broadened to address the advent of social media and advanced means of communications – which means there are emerging rules and practices of which a sponsor needs to be aware. This session will address all of the above.

Areas Covered in the Seminar:

  • Know relevant vocabulary.
  • The DDMAC Strategic initiatives.
  • Understanding DDMAC's perspective.
  • Integrating strategies and tactics for your organization.
  • DDMAC follow-up: what can happen.

Who Will Benefit:

This course is intended for anyone who has or will have a role in advertising, promotion and technical support within the FDA regulated field.  It is especially useful for organizations that are just moving toward their first approval and individuals whose role has changed or expanded into this area. This webinar will be useful to anyone who works in:

  • Marketing
  • Sales
  • Technical or Professional Services
  • Regulatory Affairs
  • Executive Management

Instructor Profile:

Ms. Janet Rose Rea, recently joined the faculty at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She also has two consulting firms. Most recently, she held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 – 2010 and AVI BioPharma from 2003 – 2008. She was also a corporate officer for both organizations.

Trained as a public health microbiologist at the University of Washington, Ms. Rea started her career with American Dade Division, American Hospital Supply Corporation in Miami Florida in the microbiology quality assurance group, applying microbiological techniques to improve aseptic processing and reducing product failure. Thereafter, she returned to Seattle, working for Genetic Systems, Immunex – where she played a key role in the approval of the company’s first product, LEUKINE®, MDS Panlabs, and Targeted Genetics. Her diverse experience transcends the product development continuum in a variety of therapeutic areas, especially oncology and rare genetic diseases.

She has been active in training and lecturing on a variety of compliance topics.

She is a member of two Editorial Advisory Boards, and has lectured extensively as well as published. She received a Bachelor of Science in Microbiology and was conferred a Master of Science of Public Health (MSPH) from the University of Washington, Seattle WA.

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