- Date: Starting on September 12, 2014
- NOTE: This seminar recurrs bi-monthly on second Fridays.
- Choose a date of your preference below when you register below.
- Friday, September 12, 2014
- Friday, November 14, 2014
- Friday, January 09, 2015
- Friday, March 13, 2015
- Friday, May 15, 2015
- Friday, July 10, 2015
- Friday, September 11, 2015
- Friday, November 13, 2015
- Friday, January 15, 2016
- Friday, February 12, 2016
About the Seminar
This seminar is intended to help you adequately implement good social medical practices to avoid FDA enforcement actions for potential misbranding of your drug or device products.
On June 27, 2014, FDA issued an untitled letter to a pharmaceutical company concerning the firm’s sponsored link on the internet search engine. FDA states:
The sponsored link provides evidence that the drug is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which renders the drug misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or otherwise makes its distribution violative.
The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP). It is imperative that firms ensure their compliance to the applicable laws and regulations when they provide drug or device information to the public through social media.
In this presentation, the speaker will discuss what to say or not to say including how to implement your good social medical practices while ensuring your compliance by avoiding potential FDA enforcement actions.
The speaker will present how to implement good social media practices in a CAC-SI manner. *: CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner.
Through this 60-min presentation, you will have opportunities to bring great value and benefits to your firm’s implementation of good social media practices in an efficient and effective manner.
About the Areas to Be Discussed
- Applicable Statute(S), and Regulations
- Regulatory Requirements
- FDA’s Monitoring and Surveillance Program
- FDA Social Media Guidance Documents
- Implementing Good Social Medical Practices
- FDA’s Untitled Letter Analysis
- Common Avoidable Mistakes
- How to Prevent Common Mistakes
- How to Avoid FDA’s Actions
- PASS-IT Guides
About the Intended Attendee(s)
- R&D Scientists, Managers, Directors, and VPs
- Regulatory Affairs and Compliance Professionals
- Clinical Affairs Professionals
- Quality Professionals
- Legal and Compliance Officers
- Marketing Professionals
- Senior Management
- Anyone Interested in the Subject
Learn more here >>