Over the last decade, pharmacovigilance professionals have witnessed a significant shift in risk management activities with regard to updated guidelines and regulations beyond North America and Europe. Despite ICH E2E efforts to harmonize risk management requirements globally, variations in regulations and approach exist depending on the country or region.
To date, risk management regulations or guidelines are in place in over 70 countries around the globe. Additionally, health authorities without established risk management regulatory requirements or guidance may request risk management plans to review or require risk management activities be implemented. As the legislative landscape continues to evolve, the pharmaceutical industry has responded by developing flexible processes to meet the various scenarios and regulatory requirements in different countries. Oftentimes, a core or global risk management strategy is developed centrally and then provided to colleagues regionally for customization to meet local requirements. Mechanisms may be established to centralize or decentralize oversight of the local development of risk management plans, as well as local implementation of additional risk minimization measures or additional pharmacovigilance activities.
Companies must be able to demonstrate compliance with risk management commitments at any point in time. Furthermore, safety leaders are accountable for the performance of their risk management system. They must be able to review performance status on a regular basis and expect proactive resolution of any potential compliance issue. Tracking and monitoring of risk management commitments pose unique challenges due to the complexity of the activities, differences in healthcare systems and use of suboptimal and disparate tracking systems.
Flexible processes and systems are necessary to meet diverse regulatory requirements for risk management programs in various countries globally. In this free webinar, pragmatic approaches to implement and monitor risk management activities will be presented. Best practices and lessons learned will be shared by providing practical examples for day-to-day compliance monitoring as well as oversight of risk management requirements.
Carla Perdun Barrett, PharmD, Senior Director, Patient Safety & Risk Management, PRA Health Sciences
Carla Barrett is a pharmacovigilance risk management expert with 20 years of pharmaceutical industry experience, including 15 years dedicated to pharmacovigilance risk management. Dr. Barrett is the former head of the Risk Management Center of Excellence (RM CoE) at Pfizer and the former head of global risk management at Allergan. She has provided strategic input to over 100 global risk management strategies including Risk Evaluation and Mitigation Strategies (REMS), European Union Risk Management Plans (EU-RMPs) and local RMPs for products in development, as well as marketed products. Accomplishments include:
- Established risk management functions in two large pharmaceutical companies
- Refined processes and systems based on global pharmacovigilance legislation
- Developed a knowledge management system for risk management
- Defined a standard approach for the development, implementation and evaluation of global risk management strategies
- Implemented best practices to enhance the quality of risk management strategies
Dr. Barrett holds Bachelor of Science and Doctor of Pharmacy degrees from the Saint Louis College of Pharmacy and completed residency training at the Medical University of South Carolina.
Dan Feith, Executive Vice President, Feith Systems and Software
Dan Feith is the head of Feith’s Life Sciences division, Orbit, where he and his team have implemented solutions for risk management, patient safety operations and surveillance at many of the world’s leading pharmaceutical companies. His leadership has driven Feith’s growth in the life sciences space, making Orbit the leading platform for pharmaceutical companies to track and manage their patient safety and risk management commitments.
Dan focuses on delivering process efficiencies to life sciences, building strong partnerships and overseeing the Orbit division.
Dan received a Bachelor of Science in Industrial Engineering from Lehigh University and an MBA from UCLA’s Anderson School of Business.
Who Should Attend?
This webinar will be suitable for senior-level professionals and safety physicians working within:
- Pharmacovigilance and Patient Safety
- Risk Management
- Regulatory Affairs
- Medical affairs
- Quality Assurance
What You Will Learn
The featured speakers will:
- Describe the processes and systems needed to address various regulatory requirements for risk management plan development and implementation at the country level
- Explain practical approaches for monitoring and tracking risk management commitments
- Discuss centralized and decentralized oversight of global risk management activities to ensure compliance
PRA Health Sciences
PRA Health Sciences is a full-service, drug development organization, providing a broad range of product development and data solution services across all phases and a wide array of therapeutic areas to biopharmaceutical companies. PRA operates in 85+ countries, with over 15,800 employees worldwide. PRA’s Real World Solutions team works exclusively in the real world research arena. Our real world evidence studies connect the companies that design and market revolutionary therapies with the patients who benefit from them and our teams innovate ways to capture, analyze, and qualify product performance — and patient experience — in the real world.