Lessons learnt from pharmacovigilance audits and inspections
In drug development, maintaining high data quality is essential for regulatory success and patient safety. Join us for this Science for Lunch event, hosted by Capish, to discover key lessons and strategies that help sponsors and marketing authorisation holders navigate audits and inspections with greater confidence – from early development through to post-approval activities.
Three Takeaways
- Gain insight into impacts of poor vs. high-quality pharmacovigilance data.
- Understand the importance of readiness for audits and inspections.
- Know how to avoid other common pitfalls related to pharmacovigilance data.
Speakers
Eva Kelty, the CEO of Capish, holds a Bachelor of Science in Statistics and boasts an extensive career in Life Sciences. With expertise spanning biostatistics, clinical study design, and management roles at CROs, she recognizes the pivotal role of rapid access to democratized data in driving project success. View profile on LinkedIn.
Elvira Santic is a pharmacovigilance expert with over 15 years of experience in drug safety across global and local settings. She has led PV operations in multinational clinical trials and managed access programs and has gained deep expertise in optimizing safety processes. Elvira also has in-depth knowledge of regulatory pathways, including FDA product registrations and EMA marketing authorization applications. View profile on LinkedIn.
About Capish
Capish is a software company, developing innovative products for exploration and visualization of drug development data. Capish offers customer specific solutions as well as standardized application setups for data repositories and for monitoring purposes. Capish also provides an extensive range of services related to purposeful utilization and future-proof management of clinical data and safety data.