14 October 11:30-13:00Uppsala Business Park Lounge, HUS 2

Lessons learnt from pharmacovigilance audits and inspections

In drug development, maintaining high data quality is essential for regulatory success and patient safety. Discover key lessons and strategies helping sponsors and marketing authorization holders to navigate audits and inspections more confidently—from early development to post-approval activities.

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

Lunch is included, with limited spots available



Speakers

Eva Kelty
CEO, Capish

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.

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Elvira Santic
Pharmacovigilance expert, Capish

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.

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CO-CREATION EVENT

UBP CO-CREATION EVENT consists of events and lectures organized collaboratively within the Uppsala Business Park Community. These events can take various forms and formats. This particular event is organized in collaboration with the UBP company Capish. 

Agenda

11:30 Lunch and Networking

Presentation

12:00 Welcome 

12.05 Presentations by Elvira Santic, pharmacovigilance expert and Eva Kelt, CEO of Capish

12:50 Q&A Session

13:00 Closing

How do I get there?

Make sure to register in time to secure a spot and enjoy a delicious breakfast. The event will take place in the Lounge next to the Restaurant in Building 2. You can find directions on the map beside.

If you’re a guest from outside Uppsala Business Park, you’ll need to check in at the security gate where you are registered. Parking and entry are via the UBP West Entrance.


Missa inte när det händer något nytt. Anmäl dig och få nyhetsmail från vår Community och Uppsala Business Park

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