State Expert Center of the Ministry of Health
Webinar “Audit of the applicant's pharmacovigilance systems – preparation, conduct, results”
The webinar will help YOU prepare for a pharmacovigilance system audit, determine the factors taken into account when drawing up the schedule of planned audits, know the stages of conducting an audit, analyze the results obtained and develop corrective and preventive actions if necessary.
The webinar will be of interest to YOU if YOU are: an authorized or contact person responsible for pharmacovigilance in Ukraine, or a representative of a company engaged in pharmacovigilance activities, or an employee of another applicant unit involved in pharmacovigilance.
During the webinar, YOU will learn about:
- regulatory legal acts governing the audit of the applicant's pharmacovigilance system;
- the role of the qualified person responsible for pharmacovigilance in preparing for an audit;
- factors taken into account when planning an audit;
- stages of conducting an audit;
- audit results and their analysis;
- approaches to developing and implementing corrective and preventive actions.
Also, YOU will be able to ask the speakers questions.
At the end of the webinar, YOU will receive a certificate of webinar participation.
Program of the webinar “Audit of the applicant's pharmacovigilance systems – preparation, conduct, results”
16.10.2020
| No. |
Name |
Speakers |
Time |
| 1. |
Audit of the applicant's pharmacovigilance system |
Yevtushenko N.M. |
1000-1040 |
| 2. |
The qualified person responsible for pharmacovigilance and their role in preparing for an audit |
Nesterchuk M.M. |
1040-1140 |
| 3. |
Factors taken into account when planning an audit |
Yevtushenko N.M. |
1140-1230 |
| Break |
1230-1330 |
| 4. |
Stages of conducting an audit |
Lohvina I.O. |
1330-1430 |
| 5. |
Audit results and their analysis |
Savchenko N.V. |
1430-1530 |
| 6. |
Corrective and preventive actions – approaches to implementation |
Lohvina I.O. |
1530-1600 |
|
Discussion |
|
1600-1630 |
Participation in the webinar is possible only after prepayment. An invoice for payment can be obtained after submitting a completed application (15 KB) (Downloaded: 25.01.2021 08:42:00) for participation in the webinar, indicating information about the payer. The completed application must be sent by e-mail to: gpvp-audit@dec.gov.ua.
Contact person: Nataliia Yevtushenko, contact telephone +38 (044) 202-17-00 (ext. 4102).
Спікери вебінару – співробітники Відділу аудиту систем фармаконагляду, які мають досвід роботи у сфері фармаконагляду.
About the Pharmacovigilance Systems Audit Department
The Pharmacovigilance Systems Audit Division was established in 2019 within the structure of the State Expert Center of the Ministry of Health to conduct audits of the applicant’s pharmacovigilance system (scheduled, targeted) in accordance with regulatory requirements, as well as to carry out advisory and methodological activities on organizing the applicant’s pharmacovigilance system and its quality systems, and to conduct audits of the applicant’s pharmacovigilance systems.
