Advertising and Promotional material compliance and review process

Peggy J Berry

Peggy J. Berry, MBA, RAC, is Keynote Speaker at ComplianceKey.She�is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs departmen........

Overview

This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented. Ensure that your company has a program in place that will ensure full understanding and communication of potential risks associated with materials and ability to mitigate risk through subtle but important modifications. Ensure a high level of compliance standards by all members of the organization.

Why should you attend this webinar?

The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, "gray areas"that must be evaluated thoroughly' how to conduct a risk assessment,strategies for mitigating risks and making challenging decision. You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards

Areas Covered in the Session:

compliance requirements
submission requirements
prior to approval
direct to consumer
social media
medical affairs
sales training
review process considerations

Who can Benefit:

Target Industry:

This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing:
Medical Affairs, Marketing, Program & Portfolio Management, Quality Assurance, Commercial/Corporate Compliance, Regulatory Affairs