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Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
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Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues relative to seminar content and for two days we will review and discuss the most recent enforcement trends and common red-flags and triggers. The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced which can affect common marketing and promotional activities on behalf of their companies. Participants will have an excellent understanding of the laws and policies and certainly FDA expectations affecting advertising, marketing and promotion, and the manner of their application in real practice. You will be better able to develop marketing and advertising programs and avoid issues which regulatory agencies, like FDA, continually review and certainly by establishing proactive strategies to mitigate compliance exposure. Attendees are encouraged to bring “real-life” examples to the seminar for interactive group discussion and benchmarking and address compliance solutions that work
• Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals and medical devices
• Receive practical, day-to-day guidance based from the latest FDA enforcement actions, and the changes taking place and being contemplated
• Get a first-hand update on the status of social media guidance documents
• Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
• Discuss the policies and actions being taken by OIG and DOJ under the False Claims Act and other Acts
• Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices and drugs
• Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion
• Conduct risk assessments for products and promotional strategies
• Reviews of business plans to identify potential misbranding issues
• Evaluate substantiation for promotional claims and potential clinical studies
• Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs
• Support the regulatory oversight for all advertising and promotional materials
• Assure that advertising and promotional materials meet applicable regulatory requirements
• Support regulatory submissions to the FDA’s Division of Drug Marketing Advertising and Communications (DDMAC)
• Development and implementation of training sessions and materials specific to regulatory compliance of advertising and promotional materials
• Support the evaluation of data to support marketing claims
• The basics of FDA law and regulations governing advertising and promotion, as well as affiliated agencies such as the FTC, 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 and recent concerns
• Issues with off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
• When disseminating medical educational materials crosses the line into improper promotion
• 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.
• Recognizing when inspectional findings or events indicate potential regulatory actions
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable
• Review and discuss pain points, challenges and solutions
• Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data
Who Will Benefit
This seminar will provide an overview and in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success. This seminar will assist personnel who have varying levels of experience in drug and device advertising, marketing and promotion. It is intended for those involved with Regulatory Affairs, Marketing and promotional legal issues, Marketing, sales and support functions but could benefit other personnel. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the advertising and promotional requirements for drugs and medical devices, including:
• Management responsible for regulatory and GMP/GLP/GCP compliance and seeking a better understanding of FDA, advertising and promotional requirements, regulatory actions and how they can improve their own firm's operations and monitoring of their state of compliance and meeting requirements
• Individuals who come in contact with regulatory inspectors
• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives
• Manufacturing managers, supervisors & personnel
• Project Managers
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Distributors/Authorized Representatives
• Legal Counsel
• Marketing Communications
• Medical Information and Affairs
Day 1 Schedule
• Introductions and Background
• Advertising and Promotion Regulation Overview
• Required Elements of All Advertising and Promotional Materials for Drugs and Medical Devices
• Laws Governing Advertising and Promotion: FDA
• Lawful Pre-FDA Approval & Pre-FDA Clearance Communication
• Promotion, Labeling and Advertising
• Misbranding/Off-Label Information and Issues
• In-Depth Analysis of Requirements for Advertising and Promotion
• FDA Enforcement Surveillance
• Social Media, Latest FDA Trends and Advertising and Promotion issues related to Social Media
• A structure for analysis of responsibility for promotion in social media.
• Recent FDA enforcement situations involving social media.
• What must product claim ads tell you?
• What are ads not required to tell you?
• Does the law say anything about the design of ads for prescription drugs?
• Has FDA done research on DTC advertising?
• How can an ad violate the law?
• Who should I tell if I think that a prescription drug ad violates the law?
• What does FDA do if it determines that an ad violates the law?
• What is Off-Label and the consequences with HCP’s?
• Off-Label Promotion Tactics and Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices
• Medical Education
• Why FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, but has limited jurisdiction over medical device advertising?
• FDA and FTC Enforcement
• The FDA has an escalating arsenal of enforcement tools from informal notices to formal administrative notices to civil actions and finally to criminal prosecution.
Day 2 Schedule
• Untitled Letter and the Warning Letters
• Injunctions/Consent Decrees
• OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA’s
• Physician Payments Sunshine Act
• The federal Anti-Kickback statute presents many potential pitfalls for medical device manufacturers looking to promote their products.
• Disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers
• Company Policies and Procedures
• AdvaMed Code of Ethics on Interactions with HCP’s
• Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs and overview of the standards with HHS-OIG Guidance
• Recent Trends and Enforcement Actions
Recap of Day 1 and Day 2
Exercise on Day 2
• Interactive Discussions
• Review Regulatory and Compliance Documentation
• Recent Enforcement Actions
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
(Contact us : 844-267-7299 | 954-947-5671
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