AIPM Ukraine, with the support of PharmRequest LLC, on March 12, 2020, a round table was held on the topic: “Pharmasurveillance – preparation for the audit of the CHP” among the Association’s member companies.

The moderators of the meeting were Dmytro Lurie (AIPM Ukraine) and Serhiy Uretiy (PharmRequest). Special thanks to all present for interesting cases and active discussion.

The subject of the discussion was the exchange of applicants’ experience in preparing for pharmacovigilance audits of the Ministry of Health of Ukraine.

The topicality of the topic is related to risks for business, in the form of a temporary ban on the use of the medicinal product, through the termination (or a complete ban – in accordance with the draft order of the Ministry of Health of Ukraine) of the validity of the applicant’s registration certificate by the Department of Health and Welfare of the Ministry of Health of Ukraine.

Topics discussed:

1. Analysis of several practical cases of comments that were discovered during audits / inspections and their practical solution.

2. What should be done so that the audit / inspection ends only with recommendations?

3. The practice of developing SOPs in accordance with the legislation of Ukraine, except for global ones.

4. Consequences of the audit of pharmacological assistance for the applicant in Ukraine.

5. Reporting of RMP, PSUR, AddCO and others to the SEC.

6. Monitoring of literary sources (newspapers, magazines), their analysis, archiving and reporting.

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

The next meeting of the round table is scheduled for June-July 2020.