Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices 2017

Topics

• Practical, day-to-day guidance based from the latest FDA enforcement actions, and the changes taking place and being contemplated
• How the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals and medical devices
• The trends reflected in the latest enforcement actions and policies issued by the FDA
• A first-hand update on the status of social media guidance documents
• Regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices and drugs
• The policies and actions being taken by OIG and DOJ under the False Claims Act and other Acts
• Risk assessments for products and promotional strategies
• Key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion
• Substantiation for promotional claims and potential clinical studies
• Reviews of business plans to potential misbranding issues
• The regulatory oversight for all advertising and promotional materials
• Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs
• Regulatory submissions to the FDA`s Division of Drug Marketing Advertising and Communications (DDMAC)
• Assure that advertising and promotional materials applicable regulatory requirements
• The evaluation of data to support marketing claims
• Development and implementation of training sessions and materials specific to regulatory compliance of advertising and promotional materials
• 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 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)
• Issues with off- label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
• The Dos and Don`ts of promoting products on the internet, including social media sites and recent concerns
• 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
• When disseminating medical educational materials crosses the line into improper promotion
• Seminar attendees are encouraged to examples of their work from the functional area on the various topics as applicable for group discussion as applicable
• Recognizing when inspectional findings or events indicate potential regulatory actions
• The latest FDA and industry trends with statistics and data regarding enforcement and inspection data
• Pain points, challenges and solutions

Who should Attend

Attendees from:

• Individuals who come in contact with regulatory inspectors
• Management responsible for regulatory and GMP/GLP/GCP compliance
• Compliance/Regulatory affairs professionals
• Auditors
• Senior management executives
• QA/QC professionals
• Project Managers
• Manufacturing managers, supervisors & personnel
• Regulatory Affairs Specialist
• Regulatory Affairs Management
• Compliance Officer