Off Label Product Use Discussions in Social Media

Off Label Product Use Discussions in Social Media

Why Should You Attend:

This webinar will examine the existing requirements on "off-label","unapproved", "unlabeled", or "extra-label" uses, as well as key elements of the FDA's New Draft Guidance, "Responding to Unsolicited Requests for Information About Prescription Drugs and Medical Devices", published in December 2011.

The discussion will explore the new or heightened issues posed by the new social media methods of rapid communication and dissemination of information or misinformation.The freedom of doctors to use products as they see fit, "according to their best knowledge and judgement", and any good results obtained from doing so, does not grant companies the right to promote such use. Just how does the FDA define "promote"? What are the risks in responding to requests for information on "off-label" use? How are such risks increased in this era of instant communication by means of social media, such as Twitter®, Facebook®, and/or business networking sites such as Linked In®?

This 90-minute presentation will answer all of the above questions and more.

Areas Covered in the Seminar:

• Unsolicited or Solicited Information Requests.
• Examples and Responses.
• Sales and Marketing "Keep Out".
• Records Required.
• Electronic / Social Media / Forums.
• Nature and Level of Specificity.
• Required Disclosures, and Allowed Labeling.
• The "Enduring" Nature of Electronic Media and the Problems.

Who will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Sales and Marketing
• R&D and Engineering
• All personnel involved in U.S. FDA-regulated medical products, promotion,and information dissemination. Especially those involved in new, emerging technologies: pharma, medical device / combination product development,and information exchange in harmony with regulatory requirements.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on virtually all CGMP issues. John is a graduate of UCLA.

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