DUBLIN, Mar 15, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "FDA Scrutiny of Promotion and Advertising Practices: 2-Day In-Person Seminar by Ex-FDA Official" conference to their offering.
If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion.
With this seminar you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message. What is more challenging is whether a consumer's mind makes its decisions on what it learns versus pre-existing emotional factors that may or may not be conscious.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments.
You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them.
With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices. What is not so easy is to know is how the potential customer or existing user will actually make their decision and act on it.
- Learn how FDA faces constitutional constraints on enforcement decisions
- Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission
- Learn how the FDA interprets advertising and promotion in principle and in fact
- Understand ways that a firm violates FDA requirements
- Evaluate advertising and promotional material based on interactive group hypotheticals
- See how sales and marketing departments play a central role, for better or worse
- Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices.
Who Should Attend:
- Sales and Marketing executives and managers
- Regulatory Managers
- In-house Legal Counsel and Contract Specialists
- 3rtd party consultants
- Venture Capitalists
- Business Acquisition Executives
- Owners of New or Developing Firms
- Own label distributors
- International Trade Managers
- Product specification developers
For more information about this conference visit http://www.researchandmarkets.com/research/kdvhgk/fda_scrutiny_of
Research and Markets
Laura Wood, Senior Manager
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SOURCE Research and Markets