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Basics of Advertising, Promotion and Labeling
Pharmaceuticals
1 July 2009
10:00 am-12:00 pm ET
The regulatory environment for the advertising and promotional labeling of pharmaceuticals continues to evolve as new FDA and industry initiatives surface. This Webcast will provide you with specific information regarding advertising and promotional labeling, that you must know to market pharmaceuticals (i.e., drugs/biologics).
You will benefit by learning from leaders in industry and the legal profession, as they share their expertise and provide a basic introduction to regulatory advertising and promotional labeling of drugs/biologics. You will also gain insight into how FDA thinks and gain practical insight into the challenges industry faces in developing quality promotional content for their various audiences.
Professional Levels: I, II
Learning Objectives:
Upon completion of this Webcast, participants should be able to:
- Summarize the basic regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of drugs/biologics; and
- Identify key regulatory issues in advertising and promotion
- List the basic requirements for proper pharmaceutical labeling
Who Should Attend:
Anyone involved in the regulatory aspect of advertising and promotion of health products, regulatory professionals, regulatory consultants, compliance specialists, food and drug lawyers, marketing representatives, drug/biologics attorneys and medical communications professionals.
Speaker(s):
Glenn N. Byrd, MBA, RAC, director, regulatory affairs, advertising and promotion, MedImmune
Byrd heads the advertising and promotions team at MedImmune, responsible for managing all regulatory activities associated with external communications for the company's products. Previously, he was responsible for all regulatory activities for marketed products at PDL BioPharma Inc., including global submissions and promotional activities. Byrd served as the Chief of the Advertising and Promotional Labeling Branch (APLB) in FDA's Center for Biologics Evaluation and Research (CBER), where he managed the team responsible for regulatory review, approval and enforcement of advertising and promotional labeling materials for biologic drugs and devices; review of blood donor incentive programs; and proprietary names for biologic drugs. Before joining CBER, Byrd worked in private industry in regulatory strategy, combination products, medical devices, and clinical trial design; he also held management positions with consulting firms and CROs and was a scientific reviewer in FDA's Center for Devices and Radiological Health (CDRH). Byrd has earned his Regulatory Affairs Certification (RAC) and holds an MBA from Hood College and a BS in aerospace and ocean engineering from Virginia Tech.
Cost: Members: $295 USD; Nonmembers: $395 USD
Cost is per site - unlimited participants
Online registration will close at 12:00 pm ET two days prior (48 hours) to the Webcast. Individuals wishing to register after this time may register only by phone.
Written cancellations received by 11:59 pm EST (5) business days prior to the Webcast will be refunded the registration fee minus a $100 administrative fee.
All you need to participate in a Webcast is Internet access and a computer with speakers and a sound card. Please note: a telephone connection will no longer be used to broadcast the presentation audio. Expert presenters virtually deliver the presentation via the Internet, while participants simultaneously view the PowerPoint slides on their own computers. A live Q&A portion following the presentation enables interaction between participants and presenters.
Questions? Call the RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.
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Webcast Information
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Online registration for this webcast is now closed. For additional registration options, please contact the RAPS Solutions Team at 1 301 770 2920, ext. 200.
View All 2009 Webcasts
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