Label Promotion of Drugs and Medical Devices
ENDED
Training by
Compliance4All
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On-Site
/ Training
USD 290.00
Details
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]
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]
Outline
Speaker/s
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. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers.
Special Offer
One Dial-in One Attendee
Price: $290.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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