Social Media Use for Marketing FDA Regulated Products: Scope and Limitations

Duration: 60 Minutes
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.
Social Media Marketing for Regulated Products.
Instructor: Mukesh Kumar
Product ID: 501037

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?

Why Should you Attend
The webinar will discuss the do's and don'ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via social media, hence it is prudent to familiarize with the current processes and plan for developments expected in the near future.

Objectives of the Presentation
This presentation 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. Areas covered are:
  • 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.
  • Recent trends in FDA enforcement actions involving social media.
  • Recent discussions about social media in marketing of FDA-regulated products.
Who can Benefit
  • 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
$375
Recorded Session for one participant
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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