URGENT PANDEMIC INFORMATION
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
Boston Professional Events List
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Link to Website
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Key goals of the conference will include learning:
- The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
- The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
- How to properly position Direct-to-Consumer (DTC) promotions
- The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
- The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
- Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
- When disseminating medical educational materials crosses the line into improper promotion; and
- Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.
Who will Benefit:
Senior executives, directors, managers and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies:
- Medical Affairs
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