Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics
Instructor:
Dr. Carla Hagelberg
Product ID: 700131
Training Level: Basic to Intermediate
- Duration: 60 Min
Failure to effectively manage safety data and pharmacovigilance processes can affect the well-being of patients, jeopardize the reputation of a company, and impact the key relationship with regulatory authorities.
Performance metrics can help a company to clarify and communicate the quality and timeline standards, guarantee compliance with regulatory requirements, gauge how well different components of the process are working, and ensure that corrective actions are put in place to improve the areas of the process that may not be performing optimally.
Areas Covered in the seminar:
- Summary of regulatory requirements for product safety reporting
- Why performance metrics are important
- How metrics can be used to analyse and improve the process for product safety
- Types of metrics used
- Examples of metrics used in product safety
- Criteria for implementing metrics successfully.
Who Will Benefit:
- This webminar is aimed at individuals with responsibilities for product safety reporting working in pharmaceutical and biotech companies, or Contract Research Organizations
- This includes:
- Drug Safety Managers and Physicians
- Quality Assurance
- Regulatory Affairs
- Clinical Project Managers
- It is also of interest to:
- IT personnel or companies involved in developing systems for product safety
- Regulatory agencies
Dr. Carla Hagelberg is the Managing Director of Innometrica Ltd, a consulting company that specializes in providing services to pharmaceutical and biotech companies. She has extensive pharmaceutical and consulting experience, particularly in the areas of pharmacovigilance and clinical development. Her work to date at a number of major pharmaceutical and biotech companies has focused on international and cross-functional integration, improvements of data and information management systems, redesign of business processes, development and implementation of metrics, training, and optimization of organizational structures. She has a successful track record of leading business change and IS projects that have resulted in significant performance improvements.
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