Regulatory and Marketing Symbiosis from Concept to Launch: How-To RAPS Webinar

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Date: 30 June 2011
Time: 12:00–1:30pm EDT

Regulatory and marketing are the two internal departments at the center of the development and approval of product claims at medical device and diagnostics companies. Product claims are the lifeblood of promotion during commercial launch and beyond. Regulatory presents the point of view of the US Food and Drug Administration (FDA) and other governmental bodies as to the rules and regulations surrounding promotion, education and scientific exchange. Marketing is the voice of the customer—physicians, healthcare providers, patients, payers—as well as sales. In short, regulatory must ensure that the company and patients are safe while marketing must advocate for healthcare providers, sales and revenue generation. This has historically put these important departments at cross-purposes.

For successful commercialization, the relationship between the seemingly opposing forces of marketing and regulatory need to be aligned very early on in the process. In this webcast, we will examine how marketing and regulatory must collaborate closely to design a product, develop support to substantiate its claims, and promote it for both optimal market adoption and regulatory compliance. These represent the best Good Promotional Practices.

This webcast will explore why it is critical for regulatory and marketing to create a symbiotic relationship in support of the claims strategy from the initial design review, including during development of:

  • Bench testing protocols for regulatory submission
  • Clinical protocols and Clinical Research Forms
  • Global sales forecasts for the sought indications
  • Promotional, educational and PR materials
  • Sales training materials

Speakers will decode the common personality traits of your marketing and regulatory colleagues and give you concrete examples of how to work together more synergistically. A regulatory-marketing interaction framework to support cross-functional symbiosis will be introduced, and balancing needs, wants and tradeoffs will be discussed. Lastly, the program will touch briefly on the need to gain consensus by putting it in writing via an SOP or other signed document.

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Learning Objectives

Upon the webcast’s conclusion, you should be able to:

  • Present why it is crucial for regulatory and marketing to collaborate from the initial design review through product and clinical testing to sales launch and beyond
  • Decode the common personality traits of your marketing or regulatory colleagues and how to work more synergistically
  • Apply the regulatory-marketing interaction framework to support cross-functional symbiosis
  • Describe the role of SOPs to memorialize the regulatory-marketing interface throughout the product life cycle

Who Should ATTend

  • Regulatory and clinical professionals in medical device, diagnostics or biotech companies
  • Regulatory and clinical professionals who interface with marketing for promotional review or design reviews
  • Regulatory and clinical professionals who conduct or are involved in conducting clinical trials
  • Regulatory and clinical professionals who sit on product development teams and submit regulatory filings
  • Marketing professionals who involved in the development of products, promotions or procedures that require regulatory input


Maureen Shaffer, Vice President of Life Sciences for Prolifiq, and Executive Editor and Publisher of Good Promotional Practices.

Elsa Chi Abruzzo, RAC, FRAPS, CQE, CQA, President and CEO of ARAC LLC, and Good Promotional Practices blogger.


Cost is per site with unlimited participants.

Note: This webcast brought to you by the Regulatory Affairs Professional Society for medical device, biotech and pharma regulatory professionals. Elsa Abruzzo, Maureen Shaffer, and Good Promotional Practices receive no compensation for this webcast.

To keep up with the best in Good Promotional Practices, subscribe to our GPP RSS feed, our Facebook page, our Twitter stream or our LinkedIn group.

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