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Ensuring Compliance with Marketing, Advertising and Promotional Requirement...

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Hilton Garden Inn San Diego / Del Mar

11025 Vista Sorrento Parkway | San Diego, CA |

Phone: +1 858-720-9500

San Diego, CA 92130

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An Interative Workshop Presented BY David R. Dills -Global Regulatory Affairs & Compliance Consultant

Course “Regulatory & Compliance Strategies: Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices“ has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate,
Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS

The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration (“FDA”). How the FDA will deal with such advanced communication technology that can go “viral” and just as quickly disappear is the question that the industry is eager to have answered.

The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or “off-label,” uses.

In the worst case, responsible executives can be criminally prosecuted for such violations under a strict liability standard, meaning that the government is not required to show that the executive had any intent to violate FDA regulations or had any knowledge of such violations. In addition, Social Media is used by healthcare professionals, sales representatives and consumers to discuss the use of prescription products for specific diseases and conditions. The use of Social Media tools and potential concerns will be addressed.

Rx drug promotion is delivered to two distinct audiences: health care professionals (HCPs) and consumers. Although tasked with regulatory oversight, FDA recognizes that promotional efforts can provide HCPs as well as consumers important information about the newest developments in drug therapies. The value of such information depends upon the integrity and completeness of the information being presented.

FDA regulates all Rx drug “promotional materials,” which includes both labeling and advertisements. Examples of “labeling” include, but are not limited to, brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides. Advertisements include, but are not limited to, materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems. Rx drug advertising to doctors, known as “detailing,” occurs in a variety of settings. In addition to medical offices, detailing occurs in hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities. The FDA also regulates direct-to-consumer (DTC) Rx drug advertising. While FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, it has limited jurisdiction over medical device advertising.

Areas Covered

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

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 other regulatory requirements seeking a better understanding of FDA, advertising and promotional requirements, regulatory actions and how they can i

    Learning Objectives

    Advertising and promotion of drugs and medical devices is a significant post-market activity of the FDA regulated industry. While maintaining a competitive marketing strategy is increasingly important in today’s marketplace, it is also critical to remain in compliance with FDA statutes and regulations regarding advertising and promotion of drugs and medical products. Disregarding these principles and requirements can result in FDA enforcement actions, including receiving a Warning Letters

Course Outline:

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

  • Seizures

  • 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 DillsRegulatory Affairs & Compliance Consultant

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. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working group

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Hilton Garden Inn San Diego / Del Mar

11025 Vista Sorrento Parkway | San Diego, CA |

Phone: +1 858-720-9500

San Diego, CA 92130

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