The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures.
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. The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures.
Attend this training to learn about the FDA’s current regulations and guidelines for advertising and promotional material compliance. Learn about industry standards for the process and procedures of an effective internal review process for materials.
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 Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Medical Affairs Departments
- Marketing Departments
- Program & Portfolio Management
- Commercial/Corporate Compliance Departments
Course Director: PEGGY J BERRY
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).