Training is integral part of success whether it is in sports or event any work. It is very much essential for establishment of quality systems. This is utmost true for quality systems in pharmacovigilance any setting like marketing authorization holders, competent authorities of Member States and the Agency.
Let's see what GVP Module I – Pharmacovigilance systems and their quality systems and other GVP Modules states about training in achieving quality systems in pharmacovigilance.
- A sufficient number of competent and appropriately qualified and trained personnel shall be available for the performance of pharmacovigilance activities [IR Art 10(1), Art 14(1)].
- Ensuring that sufficient resource available and training provided.
- All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)]. For marketing authorization holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].
- The organization shall keep training plans and records for documenting, maintaining and developing the competences of personnel [IR Art 10(3), Art 14(2)].
- Training plans should be based on training needs assessment and should be subject to monitoring.
- All staff members of the organization should receive and be able to seek information about what to do if they become aware of a safety concern.
- There should be a process in place within the organization to check that training results in the appropriate levels of understanding and conduct of pharmacovigilance activities for the assigned tasks and responsibilities
- Adequate training should also be considered by the organization for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance. Such activities include but are not limited to those related to clinical trials, technical product complaints, medical information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits.
- Appropriate instructions on the processes to be used in case of urgency, including business continuity , shall be provided by the organization to their personnel [IR Art 10(4), Art 14(3)].
- Training should support continuous improvement of relevant skills, the application of scientific progress and professional development.
- The quality systems shall be documented by training plan and records.
- Training plans and records shall be kept and made available for audit and inspection [IR Art 10(3), Art 14(2)].
- In scenario where QPPV has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC, the marketing authorization holder shall ensure that the QPPV is assisted by a medically trained person (i.e. in accordance with Article 24 of Directive 2005/36/EC) and this assistance shall be duly documented [IR Art 10(1)].
- The applicant or marketing authorization holder should provide the QPPV with training in relation to its pharmacovigilance system. Consideration should be given to additional training, as needed, of the QPPV in the medicinal products covered by the pharmacovigilance system.
Module II – Pharmacovigilance system master file (Rev 2)
- Staff should be appropriately trained for performing pharmacovigilance related activities and this includes not only staff within pharmacovigilance departments but also any individual that may receive safety reports.
- A summary description of the training concept, including a reference to the location training files
Module III – Pharmacovigilance inspections (Rev 1)
- Quality and adequacy of training, qualification and experience of staff during routine pharmacovigilance inspection
- Training and experience should be documented individually and evaluated according to the requirements of the applicable quality system of the concerned competent authority.
Module IV – Pharmacovigilance audits (Rev 1)
- Under strategic level audit planning risk to availability of adequately trained and experienced pharmacovigilance staff (e.g. due to significant turn-over of staff, deficiencies in training processes, re-organisation, increase in volumes of work) also being considered.
- The proficiency of audit team members requires a combination of education, work experience and training
Module VI – Collection, management and submission of reports of suspected
adverse reactions to medicinal products (Rev 2)
- Staff directly performing pharmacovigilance activities should be appropriately trained in applicable pharmacovigilance legislation and guidelines, in addition to specific training in report processing activities for which they are responsible and/or undertake
- Data entry staff should be instructed in the use of the appropriate standards and terminologies, and their proficiency confirmed for EU guidance on training of personnel for pharmacovigilance
- Other personnel who may receive or process safety reports (e.g. clinical development, sales, medical information, legal, quality control) should be trained in adverse events/reactions collection and submission to the pharmacovigilance department in accordance with internal policies and procedures.
- It is recognised that literature search results are a surrogate for the actual article. Therefore, it is expected that the person reviewing the results of a search is trained to identify the articles of relevance. This may be an information professional trained in pharmacovigilance or a pharmacovigilance professional with knowledge of the database used.
Module VII – Periodic safety update report (Rev 1)
- For all organizations, it is the responsibility of the person responsible for the pharmacovigilance system to ensure that the personnel, including pharmacovigilance, medical and quality personnel involved in the preparation, review, quality control, submission and assessment of PSURs are adequately qualified, experienced and trained according to the applicable guidelines (e.g. ICH E2C(R2) and this GVP Module VII).
- When appropriate, specific training for the different processes, tasks and responsibilities relating to the PSUR should be in place.
- Training to update knowledge and skills should also take place as necessary.
- Training should cover legislation, guidelines, scientific evaluation and written procedures related to the PSUR process.
- Training records should demonstrate that the relevant training was delivered prior to performing PSUR-related activities.
Explanatory Note to GVP Module VII, Revision 3
Marketing authorisation holders (MAHs) may consider training on ICH E2C (R2) guideline and the ICH
E2C Questions and Answers (Q&A) developed by the ICH-E2C (R2) Implementation Working Group
(IWG).
Module VIII – Post-authorisation safety studies (Rev 3)
- For studies that are funded by a marketing authorization holder, including studies developed, conducted or analysed fully or partially by investigators who are not employees of the marketing authorization holder, the marketing authorization holder should ensure that the investigators are qualified by education, training and experience to perform their tasks.
Module IX – Signal management (Rev 1)
- Each organization should ensure that staff members are specifically trained in signal management activities in accordance with their roles and responsibilities
- Relevant staff members within competent authorities and marketing authorization holders should familiarise themselves with the guidance and training materials on EudraVigilance outputs made available online by the Agency and the training should be documented in line with the organization's internal procedures
In short, each individual or team should be properly qualified and trained to perform designated pharmacovigilance activities (any). There should be provision on initial and ongoing training along with training plan and training documentation. Other personnel who may receive safety information (e.g. clinical development, sales, medical information, legal, quality control) should be trained in adverse events/reactions collection and submission to the pharmacovigilance department in accordance with internal policies and procedures. This also apply to members from health authority and investigators involved in clinical trials and safety studies.
