Following approval of your marketing application, the sponsor is required to comply with several regulatory requrements for the life of the product. These requirements expand to include interaction with other regulatory agancies, both Federal and State. The post-marketing obligations encompass more functional areas of the company; including sales and marketing, medical affairs, and external spokespersons.
Why Should You Attend?
Attend this webinar to learn the legal obligations following approval and the associated timimg for those activities.
- FDA Requrements
- Sales & Marketing
- Medical Affairs
- Requirements of other agencies
Peggy J. Berry,
President & CEO ,
Synergy Consulting LLC
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).
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
- Program & Portfolio Management
- Quality Assurance
- Commercial/Corporate Compliance
- Regulatory Affairs
- Associate Director