Product/Service
Marketing Pharmaceuticals 2011: Workshop For Regulatory Professionals And Promotional Review Teams
Event Brochure: Marketing Pharmaceuticals 2011: Workshop For Regulatory Professionals And Promotional Review Teams
Date(s) And Time(s):
Feb 21 2011 8:00AM - Feb 23 2011 4:00PM
Location:
Washington Marriott Wardman Park
2660 Woodley Road, NW
Washington, DC 20008
Interest Area(s):
Regulatory Affairs,Clinical Safety/Pharmacovigilance, IT/Validation, Medical Communications, Project Management, Public Policy/Law/Corp. Compliance,Quality Assurance/Quality Control
Overview:
Bring Your Marketing and Medical Team Members To Foster a Common Understanding of Advertising
and Marketing Compliance While Still Meeting Commercial Objectives.
Find out what is permissible and what is not from a US regulatory and legal standpoint. If you are a regulatory affairs professional and traditionally attend this annual meeting, now is the time to bring your marketing and medical team members together to learn about the latest enforcement actions directly from FDA DDMAC officials, government counsel, and other industry professionals.
In Just 3 Days at Marketing Pharmaceuticals 2011 You Will:
Gain a better understanding of how the regulatory and legal environment has evolved and aff ects the marketing and promotion of pharmaceuticals and medical devices
Receive practical, day-to-day guidance on what can be learned from the latest FDA enforcement actions, as well as federal and state civil and criminal actions and settlements
Hear extensive discussion of FDA's latest thinking on social media as represented in its [draft] guidance, expected late 2010/early 2011
Hear about the latest enforcement activities by three centers within FDA that regulate medical marketing: drugs (CDER), biological products (CBER) and medical devices (CDRH)
Attend breakout sessions designed for each member of your Promotional Review Team to help foster a common understanding of how marketing is conducted in a regulated environment
Learning Objectives:
At the conclusion of this conference, participants should be able to:
- Identify the trends reflected in the latest enforcement actions and policies by the FDA
- Summarize best practices by other companies in implementing regulatory policies
- Apply the FDA's guidance for the use of social media for promotional purposes
- Describe how companies can best navigate the regulatory review process at FDA
- Outline the policies and actions being taken on off -label promotion by OIG, DOJ and states
- Discuss regulatory requirements within different disciplines
- Describe how to comply with FDA and other policies
Target Audience:
Professionals in pharmaceutical, biologics, and medical device companies involved in:
- Marketing
- Marketing communications
- Legal/Regulatory Aff airs
- Public Relations/Corporate Aff airs
- Medical Information and Aff airs
- Advertising Agencies
- Compliance
- Senior Management
Event Brochure: Marketing Pharmaceuticals 2011: Workshop For Regulatory Professionals And Promotional Review Teams
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