Post Marketing and Regulatory Compliance
Duration : 90 Minutes
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, Read more
Developing Healthcare product is complex and it is critical to know the general product development lifecycle so that you can follow the correct path. Knowing which pitfalls to avoid will speed your time to market. There are many different post-marketing obligations for the manufacturers and requirements are specific to different products in different jurisdictions. Manufacturers should identify these requirements at the point of market approval or clearance in the relevant jurisdiction(s).
Attend this webinar to learn the legal obligations following approval and the associated timimg for those activities.
Course Objective:
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.
Course Outline:
• FDA Requrements
- Regulatory
- Pharmacovigilance
- Manufacturing
- Sales & Marketing
- Medical Affairs
- Quality
• Requirements of other agencies
- State
- Federal
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
