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Health Care

25/ 11/ 2020
  Further cooperation between EBA and SEC On November 25, 2020, Health Care Committee Manager of the European Business Association Dmytro Lurye, Head of HCC Registration Subcommittee of EBA Angela Kupych, and Executive Director of HCC Clinical Trials Subcommittee of EBA Irina Magdik conducted a meeting with the Acting Director of the State Enterprise State Expert Center of the Ministry of Health of Ukraine Mykhailo Babenko, Deputy Director on Registration issues of State Expert Centre of MOH of Ukraine Konstantin Kuzmenko, Deputy Director on Clinical research of State Expert Centre of MOH of Ukraine Ludmila Kovtun and SEC specialists. The meeting was devoted to the discussion of the following issues: improvement of interaction between SEC experts and applicants during online consultations; work continuation on electronic document management project of eCTD  format; optimization of terms for documents’ approval and for invoices’ issuance for the expert services; settlement of problematic issues and assistance in improving the legislation on clinical trials; improvement of the procedure for documents’ preparation before approval of the MOH Order (“proofreading” procedure) and other issues.   Mykhailo Babenko . Acting Director of State Expert Centre of MOH of Ukraine . Reference: biographical information

Further cooperation between EBA and SEC

01/

On November 25, 2020, Health Care Committee Manager of the European Business Association Dmytro Lurye, Head of HCC Registration Subcommittee of EBA Angela Kupych, and Executive Director of HCC Clinical Trials Subcommittee of EBA Irina Magdik conducted a meeting with the Acting Director of the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” Mykhailo Babenko, Deputy Director on Registration issues of State Expert Centre of MOH of Ukraine Konstantin Kuzmenko, Deputy Director on Clinical research of State Expert Centre of MOH of Ukraine Ludmila Kovtun and SEC specialists.

The meeting was devoted to the discussion of the following issues:

  • improvement of interaction between SEC experts and applicants during online consultations;
  • work continuation on electronic document management project of eCTD  format;
  • optimization of terms for documents’ approval and for invoices’ issuance for the expert services;
  • settlement of problematic issues and assistance in improving the legislation on clinical trials;
  • improvement of the procedure for documents’ preparation before approval of the MOH Order (“proofreading” procedure) and other issues.

 

Mykhailo Babenko Acting Director of State Expert Centre of MOH of Ukraine
Reference: biographical information

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