Building a World-Class Advertising and Promotion Review Program

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Peggy J. Berry she is President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development"

Compliance within the US, "gray areas"

Description

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 decisions. 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 processes and procedures to facilitate high compliance standards.

Why should you attend:

This program will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal processes to ensure 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.

Areas Covered

•       Compliance requirements
•       Submission requirements
•       Prior to approval
•       Direct to consumer
•       Social media
•       Medical affairs

Who will Benefit

•       Quality Assurance 
•       Regulatory Affairs 
•       Medical Affairs 
•       Marketing 
•       Program & Portfolio 
•       Commercial/Corporate Compliance 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Peggy J. Berry, MBA, RAC

Peggy J. Berry, MBA, RAC, 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 department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD). 

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