Medicon Valley Alliance and Capish are pleased to invite you to a Good Morning Meeting on the 22th of October 2025 in Copenhagen.
In drug development, data quality is not just a box to tick — it is the backbone of regulatory success and patient safety. Poorly managed data can result in delayed approvals, critical findings during inspections, and even risks to patients. This event is designed for QA, clinical, and regulatory professionals who want to strengthen compliance, reduce risk, and build confidence ahead of audits and inspections.
Key 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 wa
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. Read more here: www.capish.com
Date: Wednesday 22th of October 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Presentations by Elvira Santic, Pharmacovigilance Expert and Eva Kelty, CEO of Capish |
| 10:00 | Q&A session |
| 10:15 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Elvira Santic, Pharmacovigilance Expert
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. |
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Eva Kelty, CEO of Capish
Eva Kelty 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. |
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