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Labeling, Advertising and Promotion in a Regulated Environment
This Webinar is over| Date | Nov 29, 2017 |
| Time | 01:00 PM EDT |
| Cost | $250.00 |
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Online
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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.
Why should you attend it:
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 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.
Objectives of the Presentation
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 Letter, which is publicly available, or possibly more severe consequences including monetary and occasionally criminal penalties as this webinar will uncover and address with the audience.
Areas Covered
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
**If you need any help in registerting, please email me on "manu.c@onlinecompliancepanel.com" or call me on 510-857-5864.
Why should you attend it:
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 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.
Objectives of the Presentation
- Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals and medical devices
- Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
- 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
- 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
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 Letter, which is publicly available, or possibly more severe consequences including monetary and occasionally criminal penalties as this webinar will uncover and address with the audience.
Areas Covered
- 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
- 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
- Who should I tell if I think that a prescription drug ad violates the law?
- What are 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
- 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 improve their own firm's operations and monitoring of their state of compliance and meeting requirements
- Individuals who come in contact with regulatory inspectors
- Auditors
- 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 Management
- Distributors/Authorized Representatives
- Legal Counsel
- Consultants
- Marketing Communications
- Medical Information and Affairs
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
**If you need any help in registerting, please email me on "manu.c@onlinecompliancepanel.com" or call me on 510-857-5864.
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