Regulatory Affairs Project Management
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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior-level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.
- Setting tasks focused on project objectives
- Creating a project timeline and task tracker
- Assigning managing resources
- Leading effective project team meetings
- Tracking progress on tasks and overall project
- Using available tools to assist in project completion
- Ensuring effective team communication
- Re-evaluating resource needs and time constraint
- Identifying and mitigating risks to project completion
- Communicating progress to management
Who Should Attend
Regulatory Affairs, Regulatory Operations, Project Team Members across Disciplines.
This presentation is targeted toward the following organizational positions and discage 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 roles related to regulatory project management.
Why Should Attend
This program will address aspects of traditional project management with consideration of tailoring for regulatory affairs projects as well as tips for leading the team to completion and maintaining established timelines.