Valeriia Zakrasniana, Admin Assistant

Valeriia Zakrasniana

ADMIN ASSISTANT

Joined: October 30, 2024

Skills

Operations Management Problem-Solving Tech-Savviness Organization Team Collaboration

Bio

I’m a mathematician with five years of experience in operations and administrative assistance, complemented by a strong passion for organization and process optimization. My expertise lies in managing information effectively and supporting teams to achieve their goals. I am dedicated to delivering exceptional results by streamlining workflows and enhancing productivity, always striving to contribute to the success of my organization.

Hobbies

Cooking, Swimming, Psychology

Articles by Valeriia Zakrasniana

GuidanceAI/ML

2026 FDA Guidance - Clinical Decision Support Software

This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medi...

Valeriia Zakrasniana

GuidanceRegulatory

2025 FDA Guidance - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Learn FDA’s updated expectations for using real‑world data to generate real‑world evidence in medical-device submissions—includ...

Valeriia Zakrasniana

GuidanceRegulatory

2025 FDA Guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies

This guidance applies to sponsors designing or submitting clinical studies for medical devices. It highlights the importance of...

Valeriia Zakrasniana

GuidanceRegulatory

2025 FDA Guidance - Premarket Approval Application Modular Review

Applicable to sponsors submitting PMAs for medical devices and offers a flexible, staged approach to review. By allowing earlie...

Valeriia Zakrasniana

GuidanceRegulatory

2020 FDA Guidance Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

This guidance applies to in vitro companion diagnostic (CDx) devices intended for use with oncology drugs. It is relevant when ...

Valeriia Zakrasniana

GuidanceRegulatory

2019 FDA Guidance - Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Outlines FDA’s criteria for accepting and filing a PMA application. The guidance should help avoid delays, ensures efficient co...

Valeriia Zakrasniana

GuidanceRegulatory

2019 FDA Guidance - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

Applies to entities that service or modify medical devices and helps determine when those activities qualify as “remanufacturin...

Valeriia Zakrasniana

GuidanceRegulatory

2017 FDA Guidance - Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies. Guidance for Industry and Food and Drug Administration Staff

Applies when designing and submitting clinical studies for medical devices, especially those seeking FDA approval or clearance....

Valeriia Zakrasniana

GuidanceRegulatory

2016 FDA Guidance - Collection of Race and Ethnicity Data in Clinical Trials

Applies to clinical trials supporting FDA applications for drugs, biologics, and devices. It standardizes how race and ethnicit...

Valeriia Zakrasniana

GuidanceRegulatory

2014 FDA Guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies. Guidance for Industry and Food and Drug Administration Staff

Relevant to sponsors of medical device clinical studies, this guidance emphasizes the importance of analyzing and reporting dat...

Valeriia Zakrasniana
More articles by Valeriia Zakrasniana