Detailed Description of Pharmacovigilance Systems (DDPS)
As part of any licence submission in Europe a Company must be able to complete the DDPS which provides details of the Pharmacovigilance system that is in place (including the EU QP PV & Deputy) that describes how the Company will manage the Pharmacovigilance of the product if a licence is granted in accordance with EU legislation as specified in Vol IXa. This document must also be provided as part of the ICH M4 Common Technical Document (CTD) used for licence submissions in section 1.8.1.
Without the system of Pharmacovigilance in place and an EU QP PV nominated, a licence will not be granted. The DDPS also requires the Company to state the Quality Management system in place within the Company. The DDPS also requires the Company to state the Standard Operating Procedures (SOPs) it has in place and how and what is in place for data Back up; Disaster Recovery and Business Contingency all of which are in place at PharSafer®.
PharSafer® has submitted many of these on behalf of clients (using the PharSafer safety system) and helped gain licence approvals for these clients.
PharSafer® are experienced in ensuring that such a system complies with European legislation to enable clients a smooth process in obtaining a licence to market in the EU. The DDPS is an essential document and is used as part of any Regulatory Inspection for compliance.
Qualified Persons for Pharmacovigilance
PharSafer® are able to provide the services of the European Qualified Person for Pharmacovigilance (EU QP PV) and an appropriately qualified Deputy. It is a pre-requisite of all licence holders in the EU (and any Company submitting a licence for approval) that the services for an EU Qualified Person for Pharmacovigilance and suitably qualified Deputy be available to represent the Company on safety matters. As a pre-requisite, the EU QP PV must be ‘trained in all aspects of Pharmacovigilance’ (as stated in Regulation Vol IXa) and their CV must be submitted to the Regulatory Agencies for approval.
The role of the EU QP PV is critical for a Company and the choice, experience and knowledge of the EU QP PV should not be overlooked in the safety management of the Company products; systems and compliance to legislation as this is the key person to be interviewed to explain the Company’s Pharmacovigilance approach in any Regulatory Inspection in the EU.
Additionally, in the EU, there are requirements for Nationally resident QPs for Pharmacovigilance as required by National Law and PharSafer® can help provide National QPs for those EU (and non-EU) countries that require such persons.
Audits and Regulatory Inspections
PharSafer® have conducted audits both for Good Clinical Practice (GCP) and Pharmacovigilance (PV) globally covering the European Union, USA, Canada, Eastern Europe, SE Asia (Japan; India; Taiwan; South Korea) for many Pharmaceutical Companies.
The audits have been performed on behalf of Companies as part of their own internal Quality Management assessment and compliance with Company standards as well as marketing partners (distributors) in line with safety agreements.
Additionally, the audits have been performed as part of due diligence exercises for Company purchases or products and Companies.
All audits are conducted by experienced safety/clinical auditors. All audit schedules and content are agreed with the client before being conducted. All audit reports are presented as finalised documents with categorised findings according to the seriousness of the finding. All audits are certificated, signed and dated.
PharSafer® also participate in approval of any Corrective Action Plans resulting from an audit to ensure that the findings will be adequately addressed.
As part of getting Companies prepared for Inspections from the Regulatory Authorities, PharSafer® also help Companies get Inspection ready and help through an Inspection as well as help in any corrective action plans and fix the problems following an Inspection.
To date PharSafer® have participated in over 50 such Inspections and helped many Companies through these challenging times.
PharSafer® also know from experience of Regulatory Inspections because we have been inspected on site a number of times and so are more than aware of the depth and breadth of the Regulatory Inspection.
Additionally, PharSafer® has worked with many Companies in the preparation, conduct, and corrective actions following Regulatory Inspections for Pharmacovigilance and for GCP from the MHRA; IMB, FDA, Afssaps and EMEA directed Inspections.
Quality Management System (QMS)
As part of a European requirement (See Eudralex Volume 9a), all licence holders (Marketing Authorisation Holders, MAHs) are expected to engage a Quality Management System (QMS) within the Company. Such a system is designed to ensure the Company has an active quality assurance programme in place with corrective actions and also to monitor such outputs with the intention of seeing improvements within the Company in all aspects of Regulatory compliance.
The Company QMS system also forms part of the DDPS and should be part of the overall oversight of pharmacovigilance systems by the EU QP PV.
Although PharSafer® are regularly inspected by potential and existing clients; and Regulatory Authorities, this does not guarantee quality progression but does provide a quality snapshot of what was occurring at that time.
Therefore, to aid compliance and excellence, PharSafer® engage in a Quality Management approach of consulting an independent and experienced Pharmacovigilance expert to assess our processes; training and compliance approaches and outputs (since we cannot audit ourselves!) on an annual basis to ‘raise the bar’ in terms of our own expectations and client satisfaction. From the results of such an audit, we as a Company will look to improve (where necessary) our processes; training and systems to ensure that we are constantly moving forward. Quality Management is a requirement under European law to demonstrate active Pharmacovigilance excellence.
Any findings from the PharSafer® audit are shared with clients together with any corrective action plans and resolutions so that clients know any findings have been addressed.