Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.
Learning Objectives
Identify key change management strategies to lead teams effectively through organizational change and layoffs. Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions. Develop action plans to support employees, minimize disruption, and ensure business continuity.
Chair
Vidya Narayanaswamy, MBA, MSc
Monday June 16, 2025 12:10pm - 12:40pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The lifecycle of a Health Authority (HA) advice/feedback from its receipt to how it shapes and drives regulatory strategy will be uncovered with the lens of regulatory intelligence. Discuss the systems, and processes to manage HA advice/feedback
Learning Objectives
Discuss methods, techniques and best practices organizations employ to manage Health Authorities (HA) advice/feedback. Evaluate how HA advice is made searchable to gather internal regulatory precedence and how it informs regulatory strategy. Describe how to build a robust regulatory intelligence framework to manage HA advice/feedback and translate them into actionable insights.
Chair
Meena Naren Muthiah, MPH, MS, RAC
Monday June 16, 2025 12:50pm - 1:20pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.
Learning Objectives
Recognize the importance of post-approval changes in a product life cycle. Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply. Propose the key requirements to take steps industry-wide to solve "A global problem needs a global solution."
Chair
Ana Sengupta, MBA, MS, RAC
Monday June 16, 2025 1:30pm - 2:30pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
