This course provides an overview of the FDA structure and organization, regulatory history and current framework within the US for development of drugs, biologics, medical devices, dietary supplements and medical foods.
The course focuses on phase appropriate considerations and decision-making, roles involved in each stage, regulatory strategy and evolution, and agency meetings. General topics will cover all phases of the development process (including manufacturing, nonclinical and clinical development, and necessary compliance for each), options for effective and streamlined regulatory strategies that will be commercially successful, and product launch and marketing.
Benefits of Attendance
- Understand the historic evolution to the current framework for product development
- Be able to identify the basic steps in pharmaceutical development
- Gain hands-on experience of concepts and practical application of learnings
- Learn key aspects and considerations in the regulatory processes
- Understand key roles and responsibilities applicable to product development success
Peggy J. Berry
President & CEO Synergy Consulting
Peggy is the Executive Regulatory Lead at 3D Communications and President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of regulatory strategy and overall drug development.
Agenda Coming Soon