FDA's Recent Social Media Regulations: Essential Insights for Regulatory, Quality & Compliance Professionals
Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
There are three guidance documents issued by the FDA to guide the industry in the use of social media. We will cover all three guidances and provide insight as to how to interpret and implement them. These guidance documents will help you navigate the use of social media to ensure compliance.
The guidance documents relate to content, format, and liability. It is important to know under what circumstances a company is responsible for social media posts about its branded products. We will also cover the role of “influencers” and how the FDA is studying how these impact consumers.
We will also take a look at social media regulations from various areas of the world, where countries have implemented guidelines and requirements similar to those by the FDA in the US. Finally, we’ll discuss the role of the Federal Trade Commission (FTC), as it continues working with FDA to fine-tune regulations.
The FDA has the authority to issue warning letters and take enforcement actions against companies that violate these social media regulations. These actions can result in financial penalties, forced retractions of misleading content, or in some cases, product recalls.
This webinar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco, and tobacco-related (e-liquid, cigars). Applicable functions include marketing, regulatory affairs, compliance, sales, manufacturing, Quality Control, clinical study management, labeling, adverse events management, and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing, or managing the processes related to using social media to post product-related information.
The objective of the webinar is to help you understand in detail the application of the FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical to develop the appropriate strategy, policies, and procedures to ensure compliance.
As social media continues to influence how healthcare information is shared, the FDA’s regulation of its use in promoting medical products has become increasingly important. The agency's guidelines are designed to ensure that communications are truthful, balanced, and not misleading while adapting to the unique characteristics of social media platforms. Companies must stay informed of these regulations to maintain compliance and protect consumer safety.
Carolyn Troiano has more than 40 years of experience in computer systems and data in the pharmaceutical, medical device, tobacco, cannabis, and other FDA-regulated industries, as well as in banking, insurance, and government agencies. She is currently an independent consultant, advising companies on data integrity, privacy, and compliance, including implementing large-scale, complex systems, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Clinical Trial Master File (TMF and eTMF), Manufacturing, Quality, and Enterprise Content Management (ECM) systems.