Social Media and Marketing FDA Regulated Products

Why Should You Attend:

The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise. FDA also released a guidance document about manufacturers’ obligation regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition, FDA issued several letters to manufacturers indicating the rules for using social media.

But there is still much confusion among FDA regulated companies how to use social media for marketing effectively and still be compliant with regulations. How can medical device, pharmaceutical and other FDA regulated industries use social media channels like Facebook, Twitter, YouTube and LinkedIn to get their message out in a way that is compliant with advertising and promotion regulations found in the Food Drug & Cosmetic Act? This 60-minute webinar will present ways to use social media that are compliant with FDA regulations. Practical regulatory strategies will be suggested to ensure compliance and balanced social media activity.

Learning Objectives:

At the end of the seminar, the attendees will be familiar with the following

• Recent FDA guidance on controlling dissemination of information via social media.
• Common practices for using social media such as Facebook, YouTube, and Twitter.
• Meeting with FDA to discuss social media submissions.
• Trends in FDA review of social media information.
• Do's and Don'ts for managing social media for marketing your product.

Areas Covered in the webinar:

• How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
• Common ways companies are currently using social media.
• FDA advertising and promotion issues related to social media.
• A structure for analysis of responsibility for promotion in social media.
• Handling unsolicited requests for off-label information.
• Recent trends in FDA enforcement actions involving social media.
• Recent discussions about social media in marketing of FDA-regulated products.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:

• Compliance Management
• Regulatory Vice Presidents, Directors and Managers
• Attorneys – In-house or Outside Counsel
• Senior executives of pharmaceutical and device firms
• Marketing Management
• Sales Vice presidents, Directors and Managers
• Clinical Management

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA. This is hard with social media outlets where information can quickly get out of hand and lead to violation of FDA regulations, and possible penalties on the manufacturers.

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