Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT Duration: 90 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103

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In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP
audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA
compliance related issues. 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.
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. The FDA
recently held hearings addressing drug companies' use of social media and other online platforms to advertise.
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.
To register for this webinar please visit our website www.compliancetrainings.com
Marketing FDA Regulated Products Through Social Media
Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality
assurance for manufacturers and developers of FDA-regulated products. He and leads the
Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical
product development company based in Germantown, MD. His key expertise is in regulatory
affairs, clinical trials and multinational 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.
Wednesday, October 9,2013
Duration : 90 Minutes
10:00 AM PDT | 01:00 PM EDT
Speaker | Dr. Mukesh Kumar
> 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.
To register for this webinar please visit our website www.compliancetrainings.com
> Marketing Management
> Attorneys – In-house or Outside Counsel
> FDA Compliance Management
> Regulatory Vice Presidents, Directors and Managers
> Senior executives of pharmaceutical and device firms
> Sales Vice presidents, Directors and Managers