Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

Date: Jun 7-8, 2023

Time: 10 AM ET to 2 PM ET

Duration: 2 day - 8 total hours, 4 hrs./ day.

Group Packages: Please contact ben@complyrules.com

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.

Training Agenda Day 1

• Introduction
• 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
• Off-Label Promotion
• Medical Education

Training Agenda Day 2

• 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

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

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.