Dmytro Gladun

Clinical Research Expert at Polpharma Group B.V.
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Contact Information
us****@****om
(386) 825-5501
Location
PL
Languages
  • English Full professional proficiency
  • Ukrainian Native or bilingual proficiency
  • Russian Native or bilingual proficiency

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Bio

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Credentials

  • Clinical Research in Marketing
    Staff Alliance
    Dec, 2020
    - Nov, 2024
  • Clinical trial regulation. Good Clinical Practice (ICH GCP E6 ( R2))
    The State Expert Centre of MoH
    Oct, 2020
    - Nov, 2024
  • The Sixth Scientific and Practical Conference with international participation entitled “ Clinical trials of medicinal products in Ukraine: new challenges and responses to them”
    State Expert Center of MoH Ukraine
    Oct, 2020
    - Nov, 2024
  • Certificate of Completion: Accomplished level: Upper Intermediate which corresponds to level B2 on CEFR
    First Cambridge Education Centre
    Aug, 2019
    - Nov, 2024
  • Requirements for updated guidance with bioequivalence. Current regulatory requirements for medicines in the form of a fixed combination
    State Expert Center Ministry of Health of Ukraine
    May, 2019
    - Nov, 2024
  • Evidence and confirmation of equivalence of generic medicinal products and presentation of these materials in the registration dossier
    UARIGHT
    Feb, 2019
    - Nov, 2024
  • Topical issues of planning, conducting and evaluating bioavailability and bioequivalence studies
    State Expert Center Ministry of Health of Ukraine
    Dec, 2018
    - Nov, 2024
  • Product Management School (pharmacy)
    Staff Alliance
    Nov, 2018
    - Nov, 2024
  • Good Clinical Practice (GCP). Clinical trial regulation
    State Expert Center of the Ministry of Health of Ukraine
    Apr, 2017
    - Nov, 2024

Experience

  • Polpharma Group B.V.
    • Netherlands
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Research Expert
      • Nov 2022 - Present

  • Johnson & Johnson
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Site Manager/IDM
      • Oct 2021 - Aug 2022

  • Darnytsia Pharmaceutical Company
    • Ukraine
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Head Of Regulatory Affairs expert group
      • Mar 2021 - Oct 2021

    • Clinical Trials Expert & Regulatory Affairs support
      • Jul 2020 - Mar 2021

  • Kusum Group of Companies
    • India
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Manager
      • Jan 2018 - Jul 2020

      Clinical research, pre-clinical research, bioequivalence. Patent analysis. Clinical research, pre-clinical research, bioequivalence. Patent analysis.

  • Kyiv National University of Technologies and Design (KNUTD)
    • Ukraine
    • Education Administration Programs
    • 1 - 100 Employee
    • Senior Lecturer "General Biotechnology"
      • Sep 2017 - Jan 2018

      Developed and implemented a course of lectures and laboratory works in educational practice on the course "General Biotechnology" Developed and implemented a course of lectures and laboratory works in educational practice on the course "General Biotechnology"

  • Bogomolets National Medical University
    • Ukraine
    • Higher Education
    • 100 - 200 Employee
    • Assistant Lecturer "Medical Biochemistry"
      • Sep 2017 - Jan 2018

      Conducting educational seminars on biochemistry for medical students. Conducting educational seminars on biochemistry for medical students.

  • ilaya International Group S.L.
    • Spain
    • Medical Practices
    • 1 - 100 Employee
    • Researcher
      • Sep 2016 - Nov 2017

      Creation a package of documents for clinical trials, analysis and systematization of information about preclinical data, writing literature reviews and reports, participating in the development of advertising promotional materials about biotech products and information resources of company. Communication with clinical sites and organizations of research processes. Creation a package of documents for clinical trials, analysis and systematization of information about preclinical data, writing literature reviews and reports, participating in the development of advertising promotional materials about biotech products and information resources of company. Communication with clinical sites and organizations of research processes.

  • Farmak
    • Ukraine
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Analytical Chemist
      • Jul 2014 - Nov 2014

      Analysis of product quality by physical and chemical methods. Perform methods validation Work with the Pharmacopoeia of Ukraine Reporting on the analyzed products Participation in the development of the registration dossier Verification and calibration of laboratory equipment. Analysis of product quality by physical and chemical methods. Perform methods validation Work with the Pharmacopoeia of Ukraine Reporting on the analyzed products Participation in the development of the registration dossier Verification and calibration of laboratory equipment.

Education

  • Taras Shevchenko National University of Kyiv
    Master of Science - MS, Biochemistry
    2012 - 2014
  • Institute of Biology
    Master's degree, Biochemistry
    2012 - 2014
  • Kiev National Taras Shevchenko University
    PhD, Biochemistry
    2014 - 2017
  • National University of Life and Environmental Sciences of Ukraine
    Management of investment activities and international projects Master's degree, Business/Managerial Economics
    2020 - 2021

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