Tatyana Buryakina, PhD

Data-driven clinical trial protocols design and optimization

Developing a solution to enable researchers and decision makers to design and optimize clinical trial protocols using Artificial intelligence (AI) and natural language processing (NLP).
Detection and mitigation the risks associated to trial protocol development in public research as well as in pharma and biotech companies.

Maintaining patient confidentiality by protecting unauthorized access to personal information.

Staying current with health system initiatives and incorporated evidence-based practice and research into care routine

• Championed the preparation, review, and update of medical devices technical documentation, with a keen eye on global regulatory changes, especially MDR and IVDR standards
• Strategically developed and executed RA policies, aligning with evolving global regulations for markets such as the EU and 510k submissions
• Played a pivotal role in maintaining product approvals, navigating complex international standards, and ensuring timely and compliant product registration renewals
• Maintaining product approvals, ensuring standards, CER verifying and CMC regulatory, providing regional RA partners with project deliverables and support global submission activities, covering the post-market activities (PMSP, adverse events, etc.)
• Defining the timelines and requirements for country registrations to execute the project accordingly
• Identifying projects risks and issues to escalate when necessary
• KEY ACHIEVEMENTS: SEAMLESSLY MANAGED AND DELIVERED 4 PROJECTS WITHIN 6 MONTHS, REINFORCING THE COMPANY'S COMMITMENT TO REGULATORY EXCELLENCE

• Spearheaded the review, update, and implementation of pivotal IMDRF/GHTF regulatory documents, contributing to the development of global regulatory standards
• Established and nurtured collaborative ties with major regulatory agencies worldwide, including Swissmedic, ANVISA, Health Canada, and others, fostering a unified approach to regulatory affairs
• Demonstrated leadership by managing a diverse group of over 40 regulatory professionals from around the world, emphasizing cross-collaboration and consensus-building
• Engaged and liaised with key external stakeholders in the field of regulatory affairs, ensuring alignment with international best practices and standards
• Working Group management – data analysis, documents checking, teleconferences organizing, preparing, and delivering presentations, report making
• KEY ACHIEVEMENT: UPDATED DOCUMENT ON IVDS CLASSIFICATION PRINCIPLES LAUNCHED AND PUBLISHED ON JAN 2020

• Held a crucial role in the medical devices state registration process, vigilantly verifying and overseeing the quality, safety, and performance of medical devices
• Conducted comprehensive reviews of registration dossiers, including technical and clinical trials, toxicological studies, and quality certificates, ensuring alignment with international regulatory standards
• Acted as a key liaison between manufacturers and the regulatory body, offering insights and guidance on amendments required in the registration dossier to ensure compliance
• Provided expert consultation on changes in foreign regulatory rules, such as 510k, ensuring that manufacturers stayed abreast of evolving standards and requirements
• Leveraged my unique position within a notified body to bring a holistic and comprehensive approach to regulatory affairs, ensuring that products not only met but exceeded regulatory standards
• International relations supervision, cooperation with JCI (USA), contract signed and guided