Despite ICH E2E efforts to harmonize risk management requirements globally, variations in regulations and approach exist depending on the country or region.
TORONTO (PRWEB) January 20, 2020
Flexible processes and systems are necessary to meet diverse regulatory requirements for risk management programs in various countries globally.
On Thursday, February 13, 2020 at 11am EST (4pm GMT/UK), join guest speakers Carla Perdun Barrett, PharmD, Senior Director of Patient Safety & Risk Management at PRA Health Sciences and Dan Feith, Executive Vice President at Feith Systems and Software for an informative live webinar.
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 regulation or guidance may request risk management plans to review or require risk management activities to 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 compliance 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.
This webinar will be suitable for senior-level professionals and safety physicians working within:
- Pharmacovigilance and Patient Safety
- Risk Management
- QPPV Office
- Regulatory Affairs
- Medical Affairs
- Quality Assurance
For more information or to register for this event, visit Globalization of Risk Management: Think Globally, Act Locally.
ABOUT PRA HEALTH SCIENCES
PRA Health Sciences delivers innovative solutions that improve patients’ lives. Our people are passionate about the entire product life cycle, working tirelessly to provide quality results for clients. We offer exceptional experience across all phases, therapeutic areas, and a broad spectrum of solutions, ranging from full-service clinical development to our pioneering embedded model.
With 16,000+ employees covering 90+ countries, we reinforce an impressive global presence with keen local insights. Our project teams apply their understanding of local regulations, standards of care, and cultural customs to effectively align our approaches with each project’s unique goals.
At PRA, we love what we do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of 85 products now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.
To learn more about PRA, please visit http://www.prahs.com or email us at firstname.lastname@example.org.
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