Sales Team Training Requirements to Avoid Off-label Promotion: Best Practices for Social Media

Date: On-Demand
Duration: 60 Minutes
Time: 12 PM EST

Two aspects of pharmaceutical product promotion have had game-changing affects on the promotion and marketing of such products. One is the often discussed off-label promotion and another is impact of Sunshine Act on doctor-sales rep interactions. Both of these have elevated the number of digital interactions, mostly through social media, critical for all pharmaceutical sales personnel. FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients. The so-called off-label uses may be well-known to the physicians and manufacturers. While there are no restrictions on a physician prescribing off-label uses of a product, manufacturers are prohibited for “actively” promoting an off-label use. However, FDA has recently released some rules under which manufacturers and sales personnel can indeed educate the physicians and, indirectly, even patients about new uses of their products. Since the implementation of Sunshine Act, physicians are increasing reluctant to directly meet with sales reps and rather expect more digital interactions than in-person. This seminar will discuss the regulatory perspective on training your sales and marketing teams to interact with doctors and other medical professionals using social media.

Areas Covered in the Session:

Current status of physician perception of off-label and Sunshine act reporting
Trends in FDA enforcement regarding off-label promotion
Impact of Sunshine act on sales rep entry into clinics
Best practices for using social media as a communication tool and marketing
Practical tips for training of sales and marketing teams in social media usage.
Regulatory strategies for creating company policies regarding social media.

Why should you attend:
Recently the US courts have made some high-profile decisions regarding FDA’s punitive actions to manufacturers accused of off-label promotion. The Caronia and Amarin cases, have been in much discussion since in that case the court sided with the defendant accused of off-label promotion leading to speculation of its impact on FDA’s enforcement of its rules regarding off-label promotion. The legal discussion apart, these cases have raised new regulatory questions about FDA-acceptable practices for promoting off-label uses for approved products. Also, the Sunshine Act reports created intense media scrutiny of doctor-pharma interactions leading to doctors being increasingly inaccessible to sales reps. These developments have changed how sales force, doctors and other medical professionals interact. This seminar will discuss the training of sales teams in the new regulatory and marketing scenarios using social media is a pivotal tool.

Who will benefit:

This webinar will provide valuable information to:

Marketing and Advertising Professionals
Pharmaceutical sales representatives, managers, supervisors and leaders
Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers
Legal experts involved in advising manufacturers of marketed products
Senior management for companies developing new products for US market
Regulatory affairs professionals, research analysts

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.