Conference Description:

Overview:
This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents.

Why should you Attend:
This class presents the latest FDA, industry & patient thinking to assist manufacturers in enhancing the predictability, consistency, and transparency of off-label promotion of medical products, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Areas Covered in the Session:
Snake Oil Salesmen and the FDA
FDA: between patients and industry
Off-Label Promotions and First Amendment Issues
Federal Register History of the current guidance documents

Who Will Benefit:
Quality Managers
Quality Engineers
Regulatory Affairs
Regulatory Attorneys
Doctors
Health Insurance
Small Business Owners

Speaker Profile:
Angela Bazigos Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development.

Event Fee: One Dial-in One Attendee Price: US$290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]