The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: November 2, 2015 at 9am to November 3, 2015 at 6pm
Location: Hilton Zurich Airport
Street: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Zurich,Switzerland.
City/Town: Zurich
Website or Map: http://bit.ly/1FRzf98
Phone: 1-800-447-9407
Event Type: 2-day, in-person, seminar
Organized By: NetZealous LLC - DBA GlobalCompliancePanel
Latest Activity: Oct 15, 2015
Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12credits towards a participant's RAC recertification upon full completion.
Overview:
With this seminar you will learn how to navigate FDA's established legal requirements and its interpretations of promotion and advertising practices for enforcement purposes. The FDA now applies a new perspective with the use of psychological and social media behavior to aid in its determination of what a message really conveys. This becomes a new and seemingly subjective rather than objective factor in trying to stay within FDA's legal jurisdiction. Are cognitive functions really the driving motivation for decision-making?
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. The seminar will include an analysis of FDA Warning Letters and hypotheticals to inform your decision about what your firm should or should not do. 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 rather than argue over it in a meeting room.
Why should you attend?
If you go "off label" in your advertising and promotion, you become embroiled in FDA's advertising and promotion regulatory enforcement. For devices, the law is weak and lacks legal clarity. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. The Center for Drug Evaluation and Research (CDER) has established an extensive and ever expanding regulatory program. For example, policing social media has become a new regulatory responsibility. For drugs, FDA's law and extensive regulations seemingly erode your legal protection for commercial free speech. Depending on your point of view, FDA's promotion and advertising requirements can help you, hurt you or knock you out of the market. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. Do you know when you are running afoul of FDA's requirements or are you guessing
Location: Zurich, Switzerland Date: November 2nd and 3rd, 2015 Time: 9 AM to 6 PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Zurich,Switzerland.
Price: $1,895.00 (Without Stay for One Delegate)
Price: $2,295.00 (With Stay for One Delegate)
Registration Details:
NetZealous LLC - DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 1-800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/1FRzf98
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