News

EMA report on real-world data from non-interventional studies for regulatory decision-making

EMA Reflects on Real-World Data in Non-Interventional Studies for Regulatory Use

Adam Sobantka President of the Board

Group photo of speakers and organizers at the 3rd edition of the Clinical Investigations of Medical Devices conference in Warsaw, April 2025

BKWM 2025: as a Participant and Sponsor

Katarzyna Wesołowska Board Member

MHRA guidance on clinical investigations of medical devices in the UK

Clinical Investigations of Medical Devices in the UK – Updated MHRA Requirements

Ilona Korczak-Cegielska Director of Clinical & Regulatory Operations

HealthData@EU – European Commission Launches Central Health Data Platform

Izabela Chodara Director of Strategy & Operations

Our Delegation at LABS EXPO 2025 in Poznań

Katarzyna Wesołowska Board Member

Joint Discussion Paper – Future Governance of Medical Technologies in the EU

Adam Sobantka President of the Board

Remote, but Intense at Health Days 2025

Katarzyna Wesołowska Board Member

CIPS Pilot Program – Coordinated Assessment of Clinical Investigations in the EU

Ilona Korczak-Cegielska Director of Clinical & Regulatory Operations

IMDRF Terminologies for Categorized Adverse Event Reporting (AER)

Ilona Korczak-Cegielska Director of Clinical & Regulatory Operations

Enhancing Accessibility in Rapid Diagnostic Tests: WHO’s New Guidance

Izabela Chodara Director of Strategy & Operations

MFDS of South Korea and HSA of Singapore

Katarzyna Wesołowska Board Member

Konferencja B+R

B+R VIII Conference: Driving R&D Strategies in Polish Industry

Katarzyna Wesołowska Członek Zarządu

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Clinical Performance Evaluation of HIV-1 RNA Kit

Efficacy and safety evaluation in clinical trial of dermal filler

Clinical performance of HIV Ag/Ab diagnostic test

Clinical performance study of SARS-CoV-2 & influenza A/B antigen test

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