Course Description
This virtual 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.
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.
Agenda
Day 1 Training 12:00 PM EDT – 04:00 PM EDT
Session 1
Introduction
- Advertising and Promotion Regulation Overview
- Required Elements of Advertising and Promotional Materials
FDA Regulations and Laws Governing Advertising and Promotion
- Promotion, Labelling and Advertising
- Misbranding/Off-Label Information and Issues
- In-Depth Analysis of Requirements for Advertising and Promotion
- FDA Enforcement Surveillance
Advertising and Promotion Requirements
- FDA enforcement situations involving social media
- What must product claim ads tell you and 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?
- Social Media, Latest FDA Trends and Advertising and Promotional issues
Drug Ads
- 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?
Off-Label Promotion
- 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 authority over prescription drug labeling and advertising, as well as all medical device labeling, but has limited authority over medical device advertising?
- Continuing Medical Education
- Responding to requests from physicians and health care professionals
Day 2 Training Agenda Schedule Time 12:00 PM EDT – 04:00 PM EDT
- FDA and FTC Enforcement
- Warning Letters/Injunctions/Consent Decrees and Enforcement Actions
- OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA’s
- Physician Payments Sunshine Act
- Anti-Kickback statute
- Disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers
- Company Policies and Procedures
- Adva Med 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
Recap of Day 1 and Day 2
- Q&A and FAQ’s from Industry and Presenter
- Debrief/Adjourn/Wrap-Up
- Certificate Awarded to all the participants
Who Will Benefit
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
- Marketing and promotional legal issue
- Marketing, sales, and support function
- Individuals who meet 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
- Consultants
- Marketing Communications
- Medical Information and Affairs
Faculty David R. Dills
Director, Regulatory Services, CROMSOURCE
David R. Dills currently is Director of Regulatory Services at CROMSOURCE, a mid-size CRO. He has been in the industry for more than 31 years including providing global regulatory affairs and compliance consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics and biotech/biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas, including rare diseases orphan drugs on the global landscape. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers in multiple markets engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, and customer generated compliance events. He has provided oversight of GCP operations and clinical trials and prepares companies for regulatory inspections at all phases, leads efforts with regulatory submissions and post-market project leadership and guidance works with management on regulatory strategies and plans supporting a company's commercialization strategy.
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.