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Pharmacovigilance.

  • Master File
  • Audit
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300+

Reports submitted

Services

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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Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

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