Webinar: Monitoring scientific literature for Pharmacovigilance Purposes
Please join us for this webinar where Joyce de Langen, Senior Solution Manager Pharmacovigilance, will discuss the role of scientific literature for adverse event monitoring, as well as the role of literature in benefit-risk evaluation. Due to increasing amount of data that needs to be screened, literature screening for identifying adverse drug reactions is challenging for pharmaceutical companies.
Adverse drug reactions are an important risk for patient safety and have significant impact on costs of health systems. Because of this major impact on patient safety and public health, regulatory authorities worldwide have implemented new pharmacovigilance legislation in the recent years. Historically, these activities mainly rely on signal detection activities performed on data from spontaneous reporting systems. However, due to underreporting by health care professionals, new legislation focuses increasingly on the relevance of other sources of safety information, such as scientific literature, for signal detection and monitoring the benefit-risk profile of medicinal products.
- Regulatory requirements on literature screening.
- Screening scientific and medical literature for adverse drug reactions does impact patient’s safety and benefit-risk balance of a medicinal product.
- Safety information received from literature screening differs in nature and type from safety information from other sources such as spontaneous reports from Health Care Professionals and social media.
- Integration of EMA MLM Service results in literature management workflow and case management workflow.
- Literature management involves handling a large amount of unstructured data: challenges and solutions.
About the Speaker:
Joyce de Langen, Ph.D has more than 10 years of experience in the domain of pharmacovigilance and drug safety. Through her work in the pharmaceutical industry, academia and regulatory authorities, Joyce has developed a broad perspective and knowledge in pharmacovigilance and drug safety.
Mar 23, 2016 10:00 AM EDT