Pharmacovigilance

Why is Pharmacovigilance important?

Firstly, pharmacovigilance allows to provide permanent monitoring of a medical product safety profile.

Secondly, safety of patients is priority for us.

That’s why for provision of control over safety and effectiveness of application of medicinal products the company has a pharmacovigilance system, which conforms to the current laws, international standards and ethical principles of the company.

Prompt detection of adverse effects is of crucial significance for safety of medicinal products. It allows to permanently assess the balance of the ratio of effectiveness of use of medicinal products and possible risks, and implement measures aimed at prevention of adverse effects of medical therapy, increasing its safety.

For a company it is important to maintain effective feedback with each consumer, specialist in the sphere of healthcare or distributor in terms of receipt of information on safety of the medicinal products of the company.

Pharmacovigilance system

The system includes collection of information from all subjects of circulation of the medicinal product (patients, pharmacists, physicians etc.) under the conditions of real clinical practice.

Such approach allows to:

study the peculiarities of effect of products on patients

receive an opportunity to detect rare side effects

find earlier not studied facts of interaction with other medicinal products

study “behaviour” of products in vulnerable categories of population, who were not involved into clinical trials

MAXIMA HEALTH RESEARCH OFFERS

complete fulfilment of functions for creation and carrying out of activity for pharmacovigilance, appointment of an Authorised Person/Contact Person responsible for pharmacovigilance of medicinal products

monitoring, analysis, collection, and submission of notices of side effects according to the requirements of the laws of Ukraine and CIS countries detection and control of signals

development and writing of SOP/operating instructions for pharmacovigilance

development of a plan of trainings and carrying out of them for the employees of your company

monitoring of literature and mass media on the information about safety of medicinal products

development (writing) and/or completion of a Risk Management Plan (RMP), Periodic Safety Update Report (PBRER / PSUR), Addendum on clinical overview (ACO)

introduction of additional measures for minimisation of risks of medicinal products

communication with local regulatory authorities

development and support of the Pharmacovigilance System Master File (PSMF)

development of documents on the pharmacovigilance system quality control system

development of Safety Data Exchange Agreements (SDEA)

Result-oriented high-quality service!

MAXIMA Health Research with long-term experience in registration and post-registration support of different kinds and types of products has profound knowledge of requirements of the current laws and offers you to carry out any required regulatory procedures qualitatively and quickly, and most importantly according to the current laws and strategy of the company.

Our company successfully provides services for regulatory activity to pharmaceutical and FMCG companies, so we are ready to answer any of your questions.

Contact us

Regulatory Intelligence in Life Sciences

Contact information

The office of MAXIMA Health Research is located in the office center of Delta Medical, at the address:
st. Chornovola, 43, Vyshneve, Kyiv region, 08132, Ukraine

tel.: +38 (044) 593-38-86
tel.: +38 (044) 593-33-55
fax: (044) 593-33-54

info@maxima-health.com

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