“Pharmacovigilance – preparation for audit of SEC” 12.03.2020

AIPM Ukraine with the support  PharmRequest LLC on March 12, 2020, organized the table on the topic: “Pharmacovigilance – preparation for audit of SEC” among the member companies of the Association.

The meeting was moderated by Dmitry Lurie (AIPM Ukraine) and Sergey Urety (PharmRequest). A special thanks to everyone in attendance for interesting cases and for active discussion.

The subject of the discussion was the exchange of experience of the Applicants in preparation for audits on pharmacovigilance of the SEC of Ministry Health of Ukraine.

The relevance of the topic is related to the risks to the business, in the form of a temporary ban on the use of a medicinal product, by termination (or complete ban – in accordance with the draft order of Ministry Health of Ukraine) of the registration certificate of the applicant by the SEC of Ministry Health of Ukraine.

Topics discussed:

  1. Analysis of several practical cases of comments that were identified during audits and their practical solution.
  2. What should be done to ensure that audit ends only with recommendations?
  3. The practice of developing SOPs in accordance with the legislation of Ukraine, except global ones.
  4. Consequences of the pharmacological assistance audit for the applicant in Ukraine.
  5. Reporting on RMP, PSUR, AddCO and others to the SEC.
  6. Monitoring of literary sources (newspapers, magazines), their analysis, archiving and reporting.

Following the results of the round table, participants worked out instructions for the next meeting, the main task of which will be to organize a meeting with the State Expert Center of the Ministry of Health of Ukraine.

The next roundtable meeting is scheduled for June-July 2020.