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
About the Seminar Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.
Recently, Dr. Lim developed premarket notification 510(k) and premarket approval (PMA) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
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- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $199
LIVE (≤ 4 attendees): $699
LIVE (≥ 5 attendees): $899
LIVE & Recorded: $299