Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

By: David R. Dills, Director of Regulatory Services at CROMSOURCE.
Product code: SEM50
Location 1: San Francisco CA Feb 27 - 28

Description

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

"Course “Writing Effective SOPs" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion"

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

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 of business plans to identify potential misbranding issues
•        Evaluate substantiation for promotional claims and potential clinical studies
•        Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs
•        Support the regulatory oversight for all advertising and promotional materials
•        Assure that advertising and promotional materials meet applicable regulatory requirements
•        Support regulatory submissions to the FDA’s Division of Drug Marketing Advertising and Communications (DDMAC)
•        Development and implementation of training sessions and materials specific to regulatory compliance of advertising and promotional materials
•        Support the evaluation of data to support marketing claims
•        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).
•        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
•        Issues with off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
•        When disseminating medical educational materials crosses the line into improper promotion
•        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.
•        Recognizing when inspectional findings or events indicate potential regulatory actions
•        Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable
•        Review and discuss pain points, challenges and solutions
•        Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data

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 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
•        Distributors/Authorized Representatives
•        Legal Counsel
•        Consultants
•        Marketing Communications
•        Medical Information and Affair

Learning Objectives

Pharma , Medical Device & Biotech 

Course Outline:

(8:30 AM – 4:30 PM)

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.

 

(08:30 AM to 04:30 PM)

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 
Debrief/Adjourn/Wrap-Up

 

speaker

David R. DillsDirector of Regulatory Services at CROMSOURCE

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, among other regulatory and compliance responsibilities. 

27-February-2019 To 28-February-2019 San Francisco CA
Seminar One Registration
$ 1596



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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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