Pharmacovigilance Medical Writing Services
PharmaVigilance team is well experienced in writing different types of PV documents and can provide a comprehensive solution to a client for aggregate reporting. We can support you with the writing of various documents such as:
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMSs);
- Pharmacovigilance System Master Files (PSMFs);
- Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs);
- Addendum to Clinical Overviews (ACOs);
- Periodic Adverse Drug Experience Reports (PADERs);
- Developmental Safety Update Reports (DSURs);
- Standard Operating Procedures (SOPs);
- Literature search, analyses and ad-hoc benefit-risk assessments.
Training and Workshop Services
According to the regulations, all personnel involved in the performance of PV activities within an organisation must receive initial and continued training. This training must relate to the roles and responsibilities of the personnel. Additionally, the organisation must ensure that all personnel are aware of appropriate instructions on the processes to be used in case of any urgency, including business continuity. We provide bespoke training covering different aspects of PV and so can customise the content to suit your needs and requirements. We provide training in different areas; some of the examples include:
- PV auditing;
- Preparing for audits and Regulatory inspections;
- Basic foundation course for PV;
- Qualified Person for Pharmacovigilance (QPPV);
- Customised training on PV GVP Modules;
- Writing a case narrative;
- Establishing and implementing PV Quality Management System.
Pharmacovigilance Quality Management System
We offer our services to support small to medium sized pharmaceutical companies to establish PV quality management systems based on GVP Module I – Pharmacovigilance systems and their quality systems in the EU. We have experience in writing PV related documentation such as RMPs, PSMFs and critical SOPs to support MAAs in the EU. We can advise you on establishing a PV system in the EU and can also help you to transfer the system in-house in case it has been established previously on an outsourcing model.
EU Qualified Person for Pharmacovigilance
According to the EU regulations, as part of the PV system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately QPPV in the EU. We can support the QPPV in the EU by reviewing documents such as aggregate reports (PBRERs and DSURs), Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements (PVAs), etc. on behalf of the QPPV.
Pharmacovigilance Regulatory Inspection
Various Regulatory Authorities are coming together and exchanging information regarding the findings from the PV inspections they conduct at different pharmaceutical companies. The PV systems are being scrutinised and assessed in great depth during inspections. We can support you by identifying any gaps in your PV system prior to inspection and help you in rectifying those gaps in the best possible way. We can help and guide you so that you are well prepared for the inspection, with our following services:
- Inspection Readiness: We provide a complete package including guidance, training and support leading up until the actual inspection, and also during the inspection.
- Mock Inspection: We conduct mock inspections to mimic the real inspections. This will help you to understand the inspection process better and prepare you to face the questions from the inspectors in a real inspection situation.
- Summary of Pharmacovigilance System (SPS): We provide support to complete the SPS which requires submission to Regulatory Authorities prior to the inspection.
- Corrective and Preventive Action (CAPA) Plan: We can also provide post-inspection support for putting together the CAPA plan and then managing it up until its completion.
Due to the stringent regulations and increasing demands from Regulatory Authorities, the pharmaceutical companies must ensure that a robust PV system is in place which is being monitored and improved continuously in order to provide patient safety. We can help you to achieve this to high standards with our following services:
- Conducting Audits: Our audit activity includes conducting audits of pre and post marketing PV systems and documentation, affiliates, distributors, marketing partners and service providers, QPPV Office, process audits such as patient support programmes and aggregate report writing processes, etc.
- Conducting Gap Analysis: We conduct gap analyses and identify gaps in PV systems by assessing against the regulatory requirements. We offer expert advice and solutions to rectify any deficiencies observed during these analyses.
- Preparing Checklists for Audits: We provide checklists to support and guide the auditors during the audit process. This is also included in our training program for conducting PV audits.
- CAPA Management: We provide post-audit and post-inspection support for CAPA management. We provide expert advice on performing root cause analyses and determining a suitable CAPA plan to address the findings. This is then followed up with the implementation of the CAPAs within the timelines agreed with the Regulatory Authorities.