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.
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.
Areas Covered in the Session :
Applicable Statute(s) and Regulations
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
Who Will Benefit:
R&D Scientists, Managers, Directors, and VPs
Regulatory Affairs and Compliance Professionals
Clinical Affairs Professionals
Legal and Compliance Officers
Anyone Interested in the Subject