Pharmacovigilance

Otipharm LLC is a pharmacovigilance provider for international pharmaceutical companies.

Our clients

Qualified Person responsible for pharmacovigilance

The safety of our products and our patients is top priority. If you want to report the occurrence of an adverse reaction and / or lack of effectiveness in the medical use of Bioton S.A. products, please contact the Bioton pharmacovigilance specialists.
The safety of our products and our patients is top priority. If you want to report an adverse reaction and / or lack of effectiveness in the medical use of China Resources Zizhu Pharmaceutical Co., Ltd products, please contact Zizhu Pharmacovigilance Specialists.
Adverse reaction hotline phone

Components of pharmacovigilance

Pharmacovigilance Qualified Person
For the full and uninterrupted functioning of the pharmacovigilance system, each owner of a registration certificate and a manufacturer of medicines must have an appropriate specialist - an Qualified Person responsible for pharmacovigilance. It is mandatory for foreign companies to find a Pharmacovigilance Contact Person (Local qualified person responsible for pharmacovigilance - LQPPV). QPPV and LQPPV is a specialist with a pharmaceutical or medical education who has sufficient experience and appropriate qualifications to carry out pharmacovigilance in the format of 24 hours 7 days a week.
Preparation of pharmacovigilance master file
Pharmacovigilance is a well-coordinated and well-functioning system that functions to obtain, analyze and respond to information on the safety of medicines - about cases of adverse reactions and lack of information on medicines. The pharmacovigilance system has certain components and a clear structure, which are described in a specialized document - the master file of the pharmacovigilance system.
To create this document, specialized specialists with experience and knowledge should be involved, because this is the main document that describes pharmacovigilance activities.
Telephone hotline
In order to carry out pharmacovigilance in the format of 24 hours 7 days a week, the Qualified person responsible for pharmacovigilance or the Pharmacovigilance Contact Person should be able to receive information on the safety of medicines - about cases of adverse reactions and lack of information on medicines. For this, a valid channel for obtaining information is formed - a round-the-clock hotline, such a tool eliminates the possibility of skipping a patient or health care provider for safety concerns.
Pharmacovigilance Training
A pharmacovigilance system is not possible without qualified and trained personnel. In addition, absolutely all company personnel are involved in pharmacovigilance, whether it is a manufacturer of medicines, a representative office of a foreign company or a distributor of medicines. For the purpose of staff training, the Qualified Person responsible for pharmacovigilance or the Pharmacovigilance Contact Person should conduct trainings for all staff at least 2 times a year.
RMP

Risk management system

EU Risk Management Plan Guide includes:

  • information on how its risks will be prevented or minimized for patients;
  • Drug Safety Profile
  • Measuring the effectiveness of measures to minimize risks.

EU Risk Management Plan Guide includes:

  • research plans and other activities aimed at gaining deeper knowledge about the safety and effectiveness of drugs.
  • RMPs are constantly modified and updated throughout the life of the drug as new information becomes available.

We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products

DOWNLOAD PDF