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Organises and carries out a set of works to:
  • supervise and ensure quality of clinical trials of medicinal agents at the pre-registration and post-registration stages pursuant to the requirements of the Good Clinical Practice;
  • organise and carry out the biostatic stage of study of bioequivalence of generic medicinal agents;
  • detect, record, and control side effects of medicinal agents;
  • develop and carry out expert examination of programmes (reports) of clinical trials of medicinal agents, medical equipment and medical devices pursuant to the requirements of the Good Clinical Practice;
  • expert examination of medical advertising materials concerning compliance with the requirements of the legislation of the Republic of Belarus and issuance of the permit to place those advertising materials in the territory of the Republic of Belarus;
  • expert examination of registration documents for the procedure of state re-registration of medicinal agents in the Republic of Belarus;
  • expert examination of documents and examination of healthcare institutions to issue the permit to carry out clinical trials of medicinal agents;
  • organise and hold seminars for researcher doctors according to the national and international regulations of the Good Clinical Practice with issuance of the certificates of the model approved.