About Oleksandra Bystrova

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So far Oleksandra Bystrova has created 16 blog entries.

Early Access Programs (EAPs) in France: A Strategic Advantage for Pharma and Biotech Companies

Introduction Early Access Programs (EAPs) in France provide pharmaceutical and biotech companies with a valuable opportunity to offer patients innovative treatments before obtaining formal marketing authorization. Regulated by the French National Agency for the Safety [...]

By |2025-03-19T16:10:55+00:00March 6th, 2025|Uncategorised|

The importance of a strong Clinical Monitoring team when collecting data in an EAP

Expanded Access Programs (EAPs) allow patients with serious or life-threatening conditions to obtain investigational treatments outside of the clinical trial setting. Because they are not formal clinical trials, EAPs do not require as much data [...]

By |2025-02-20T10:52:48+00:00February 17th, 2025|WEP Insights|

The need for Harmonized Regulations in the Expanded/Early Access, Compassionate Use and Named Patient Use space

Expanded/Early Access (EA), Compassionate Use (CU) and Named Patient Use (NPU) are critical pathways for patients with serious or life-threatening conditions to obtain investigational treatments outside of clinical trials. While these programs offer hope for [...]

By |2025-02-11T12:53:50+00:00February 6th, 2025|WEP Insights|
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