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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

    • The focus of data auditors and inspectors
    • The flaws and inconsistencies that raise concern
    • The DO’s and DON’Ts of data presentation, learnt the hard way


    Lunch is included, with limited spots available



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    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.


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