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Strategic-Planning Description : The seminar 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. 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. 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 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 in the Session : > 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: > 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 Speaker Profile: 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. 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. 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. About the Author: 相关的主题文章: