Conference & Events
FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel
This webinar will discuss the FDA's current thinking on good practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e.g., social media or other public electronic media). In addition, several public comments will be discussed in response to the FDA's recent guidance document.
Date: 07 June 2012 - 11:00
1000 N West Street
Contact for Event Information
Name : Online Training
United States of America
Contact Useful link:http://www.globalcompliancepanel.com
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.
Pursuant to the Act and applicable federal regulations, firms (e.g., drug or medical device manufacturers) are prohibited from disseminating information of any new intended use (off label information) that has not determined to be safe and effective or that is outside FDA's substantial equivalence termination (clearance) for devices requiring premarket notification [section 510(k) of the Act] requirements. Statements made in a way to promote a drug or medical device for uses other than those approved or cleared by FDA may constitute “evidence of a new intended use.” It is imperative that firms understand and accurately interpret the statutory provisions and FDA regulations governing label, labeling and off-label promotion within the meaning and scope compliant with the FDA's current thinking and the applicable statutory and regulatory requirements.
Why should you attend: To achieve compliance and to remain compliant with the FDA-compliant practices for disseminating off-label information through electronic media, it is critical to get familiar with the FDA's current thinking on the topic. This webinar is intended to discuss FDA's current thinking on the topic: how to disseminate off-label information through electronic media?
Areas Covered in the Session:
Review of relevant and applicable statutory provisions.
Review of implementing FDA regulations.
Discuss label and labeling within the meaning and scope compliant with FDA's current thinking.
Discuss the differences between the solicited requests and unsolicited requests for off-label information.
Discuss the differences between public unsolicited requests and non-public unsolicited requests.
Discuss how to disseminate off-label information to the public in a manner acceptable.
Discuss how to respond to non-public or public unsolicited requests for off-label information about FDA-approved or cleared products (drugs and medical devices) (e.g., requests made through social media or other public electronic media).
Discuss FDA's current recommendations to firms wishing to respond to unsolicited requests for off-label information.
Discuss the best practices for disseminating off-label information responding to public and non-public unsolicited requests.
What is acceptable and not acceptable?
Discuss who should and should not respond to the non-public and public unsolicited requests for off label information and how to respond.
Discuss the nature of the Citizen Petition filed on behalf of several drug manufacturers regarding how to disseminate "off-label" information.
Recent enforcement actions
Speaker's practical, actionable and strategic solutions to disseminate off-label information: "CAC-SI" method
Who Will Benefit:
Regulatory Affairs Managers, Directors and VPs
Clinical Affairs Managers, Directors and VPs
Quality Managers, Directors and VPs
Quality Managers, Directors and VPs
Compliance Managers and Directors
Sales and Marketing Managers, Directors, and VPs
Complaint Handling and Risk Management Managers and Directors
Site Managers, Directors, and Consultants
Senior and Executive Management
Compliance Officers and Legal Counsel
Business Development Managers, Directors, and VPs
Live : $245.00
Corporate live : $995.00
Recorded : $295.00