Overview:With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.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.Why you should attend: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, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. Areas Covered in the Session:FDA's legal authority and Constitutional limitationsFDA requirements and exemptionsFDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit informationWarning LettersWho Will Benefit:Regulatory AffairsQuality AssuranceManufacturingFDA Consultants and Legal CounselDATE, VENUE & PRICE:Location: Raleigh, NC Date: September 17th & 18th, 2015 Time: 9 AM to 6 PM Venue: Courtyard Raleigh MidtownVenue Address: 1041 Wake Towne Dr, Raleigh, NC 27609, United StatesPrice: $1,695.00Register now and save $200. (Early Bird)Until August 10, Early Bird Price: $1,695.00From August 11 to September 15, Regular Price: $1,895.00Contact Information: NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407Fax: 302 288 6884
When
17 Sep 2015 @ 09:00 am
18 Sep 2015 @ 06:00 pm
Duration: 1 days, 9 hours
Where
Courtyard Raleigh Midtown
1041 Wake Towne Drive
United States
Language
English en
Organised by
GlobalCompliancePanel (deactivated) Event published: 15 May 2015
Event last updated: 18 Jul 2016