Pharmacovigilance.

  • Master File
  • Audit
  • RMP
300+

Reports submitted

Services

X7 Clinicals and Pharmaceuticals Research EU OÜ focuses on regulatory affairs and pharmacovigilance services. Pharmacovigilance – receiving and processing of drug safety information about marketed medicinal products for pharmaceutical companies, collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pharmacovigilance Outsourcing

A comprehensive solution for small and medium-sized companies.

Our advantages:

  • We fully assume all the responsibilities for pharmacovigilance
  • We constantly monitor new requirements in each country and instantly react to all innovations
  • We provide all necessary interactions with regulators
  • We develop and implement an effective SOP system
  • Reliable Authorized Person and Experienced Team

Pharmacovigilance in other countries

Compliance with local requirements of other countries (including the EAEU and the CIS).

Our advantages:

  • A wide network of contact persons for pharmacovigilance
  • Compliance with the local requirements of each country
  • Constant monitoring of local literature and normative documentation
  • Effective interactions with local regulatory authorities

Continuous security monitoring in all countries.

Consulting services

Assistance on any questions in the field of pharmacovigilance.

Our advantages:

  • Consultations on the introduction of the pharmacovigilance system in the enterprise
  • Analysis and preparation of recommendations for improving the quality of the developed documentation (SOP, instructions, etc.)
  • Assistance in the development and correction of periodic reports (including the compilation of reports in the format required by Roszdravnadzor)
  • Assistance in the preparation of responses to requests from regulators

Pharmacovigilance system construction

Our advantages:

  • We can integrate into the process of creating a pharmacovigilance system at any stage
  • We will develop or improve the Master File of Pharmacovigilance System
  • Create an effective SOP system built into the existing quality system
  • We will develop templates of documents for comfortable further work
  • We will train employees (including distance learning for remote employees)

Pharmacovigilance audit

Analysis of the existing pharmacovigilance system. Identify weaknesses, recommendations for improvement.

Our advantages:

  • We analyze the pharmacovigilance system at any level with recommendations for improvement
  • We conduct pre-audit activities to prepare for audits from regulators
  • We carry out annual internal audits – in accordance with the requirements of the legislation

Continuous quality control and improvement of the existing system.

GVP Training

X7 Research provides training courses on Good Pharmacovigilance Practices.

Training program:

  • Basic concepts of the pharmacovigilance.
  • General requirements for the implementation of the pharmacovigilance in the Russian Federation and the EAEU.
  • Authorized person for pharmacovigilance. Requirements for the authorized person, their appointment
  • Quality management of the pharmacovigilance system. Standard operating procedures.Master-File Pharmacovigilance System. Development, the main sections. The procedure for updating information.
  • Handling individual cases of side effects. Coding. Causes and effects of using the drug.
  • Clinical research safety records. Adverse reactions form. Evaluation of severity criteria.
  • Safety drug databases. Principles of a paperwork.
  • Signal management.
  • Development of a Periodic Update Safety Report. The main sections and principles of preparation. Information search. Terms of reporting to regulatory authorities.
  • Periodic safety report of a drug under development (ROOB)
  • Measures to minimize risks. Development of a Risk Management Plan.
  • Staff training.
  • Inspections and audits of the pharmacovigilance system. Periodic audits.
On completion of the course, each employee receives a certificate of GVP training from X7 Research Company Limited.
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