Basic elements and processes of the pharmacovigilance system. Critical processes of the pharmacovigilance system

Basic elements and processes of the pharmacovigilance system. Critical processes of the pharmacovigilance system

Details

  • Start date: 01 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 02 December 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 2 days, 8 academic hours
  • Break: yes
  • Category: Pharmacovigilance
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    ₴5000/€250 + ₴4500/€225 for each next participant

     

    Target audience: authorized persons / their deputies responsible for pharmacovigilance at the global level and local offices, pharmacovigilance specialists, quality assurance specialists of the pharmacovigilance system. Also, this webinar will be useful for regulatory specialists, clinical trial managers, specialists in the development of clinical trial documentation, pharmacovigilance documentation specialists, directors of global regulatory affairs, pharmacovigilance directors, medical directors, heads of registration and regulatory requirements, heads of clinical trials, medical information specialists, instructional writers.

     

    Questions will be considered:

    • The concept, goals and objectives of pharmacovigilance. Definition of pharmacovigilance. Strategy for building a global pharmacovigilance system.

    • Place of pharmacovigilance in a pharmaceutical company. The role of management in ensuring the proper functioning of the pharmacovigilance system. The need to build a global pharmacovigilance system. Global regulatory strategy of the marketing authorization holder and planning stages for building a global pharmacovigilance system in accordance with current pharmacovigilance requirements.

    • Regulatory and legal framework governing pharmacovigilance in Ukraine, the countries of the EAEU, CIS countries, the EU, the USA.

    • Good Practice Guidelines for GVP Pharmacovigilance. Challenges in building a pharmacovigilance system.

    • Qualified person responsible for pharmacovigilance, qualification requirements. Peculiarities of QPPV activity in Ukraine, EAEU countries. Functional duties and powers, rights of the qualified person responsible for pharmacovigilance. Responsibility of the qualified person responsible for pharmacovigilance. Place and subordination of the holder of the registration certificate. Requirements for a local person responsible for pharmacovigilance. The right to sign documents. Examples of the job description of the QPPV.

    • Delegation of QPPV functions. Involving (if necessary) other persons and organizations in the implementation of PV by concluding contractual agreements. Master service agreements. Examples of agreements. Outsourcing of pharmacovigilance services.

    • Compliance of job descriptions of personnel performing pharmacovigilance functions with the duties set out in documented procedures.

    • Availability of a structured system for the organization of PV, its updating and support. Qualification and education requirements for pharmacovigilance specialists. Job descriptions for pharmacovigilance specialists. The structure of the pharmacovigilance unit. How to correctly calculate the amount of resources for the pharmacovigilance system: global and local levels. Calculation scheme. Practical example.

    • Documentation of the pharmacovigilance system. Definition, meaning, types. documentation levels. Documentation requirements. Documentation management (diagram). Documentation quality system in the company in the context of pharmacovigilance. Data protection.

    • Creation and maintenance of the relevant databases.

    • Providing training to the company's personnel to perform activities related to PV. Implementation of pharmacovigilance training in the overall GxP training system.

    • Maintenance of documentation on PV, including its storage and archiving.

    • Establishment of a risk signal management system in PV. Requirements for the process of collecting, analyzing information on the safety of the use of drugs. Requirements for the company's drug security database. Evolution from reporting an adverse reaction to signal and risk within the proper functioning of the pharmacovigilance system.

    • Creation of a quality management system for the PV system. Components of the quality system of the pharmacovigilance system. Documentation of the quality system of the pharmacovigilance system. Models of the quality system of the pharmacovigilance system.

    • Quality system in pharmacovigilance processes.

    • Implementation of the global pharmacovigilance system in the pharmaceutical quality system of the marketing authorization holder. The order of interaction between the quality system and the global pharmacovigilance system.

    • Critical processes of the quality system of the pharmacovigilance system. Analysis of processes. Practical examples.

    • Recommended procedures (SOPs) for the quality system of the pharmacovigilance system. Practical examples at the global, local levels of the pharmacovigilance system.

    • Ensuring the continuity of the pharmacovigilance system. Plan for ensuring the continuity of the functioning of the pharmacovigilance system.

    • Agreements on the exchange of information with partners, distributors. Service agreements for the provision of pharmacovigilance services between pharmaceutical companies and outsourcing companies.

    • Pharmacovigilance System Master File. Goals of the Pharmacovigilance System Master File. Types of Pharmacovigilance System Master File, its location, delegation of responsibilities for Pharmacovigilance System Master File. Pharmacovigilance System Master File format and structure, Pharmacovigilance System Master File mandatory information, summary of sections. Maintaining and maintaining the Pharmacovigilance System Master File up to date, making changes to the Pharmacovigilance System Master File, monitoring changes. Presentation of the Pharmacovigilance System Master File.

    • Active interaction of the pharmacovigilance system with subdivisions of a pharmaceutical company as one of the conditions for ensuring the proper functioning of the pharmacovigilance system.

    • Building a signal management and risk management system in the global pharmacovigilance system. Requirements for the process of collecting, analyzing information on the safety of the use of drugs. Requirements for the company's drug security database. Evolution from reporting an adverse reaction to signal and risk within the proper functioning of the pharmacovigilance system.

    • Development of documentation on pharmacovigilance (generation of PSUR, development of risk management plans, additions to clinical examinations, taking into account the requirements of the current legislation on pharmacovigilance of the countries where drugs are used).

    • Answers to questions from online workshop participants.

Speakers