Off Label Product Use Discussions in Social Media

Instructor: John E Lincoln
Product ID: 702264
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2012

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This 90-minute webinar will review FDA expectations/ requirements for discussing off label uses of medical products on social media, e.g.,Twitter®, Facebook®, etc. We will also discuss key elements of the FDA's new Draft Guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", Dec 2011.

Course "Off Label Product Use Discussions in Social Media" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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requirements on "off-label","unapproved", "unlabeled", or "extra-label" uses, as well as key elements of the FDA's New Draft Guidance, "Responding to Unsolicited Requests for Information About Prescription Drugs and Medical Devices", published in December 2011.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

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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