Other Safety Provisions
XEVMPD (Eudravigilance Medicinal Product Database)
In Europe, there is a requirement to register your company products, both clinical and post-marketing, on to the Eudravigilance product dictionary database (XEVMPD). This is also a service PharSafer® can provide for you cost effectively.
We have SOPs in place and trained EU approved staff to enter and maintain your company product details on to the XEVMPD to maximise your compliance.
Standard Operating Procedure (SOP) Writing
PharSafer® has a complete suite of our own SOPs to accommodate all of the activities we perform for our clients – in excess of 100 SOPs, Working Practices, Templates and User Manuals. These SOPs can be scrutinised by clients during any audit of our capabilities. We have a detailed approach to the production, approval and effective dates for our SOPs, together with a detailed revision process and retirement methodology. Our staff are carefully trained on these SOPs, completing regular competency assessments to ensure understanding and accuracy.
Some of our SOPs are also supported by Working Practice Documents (WPDs), which are also part of our document control systems, as are our template and version controlled forms and template reports (e.g. DSURs; PBRERs; RMPs and Safety Reviews).
Clients wishing to formalise their own in-house procedures have also used our services for SOP writing in order to have simple, effective, process driven SOPs that accurately describe their activities. Due to our extensive knowledge of Regulatory Inspection requirements, we are well aware of what written processes the Regulatory Authorities expect to see as part of their assessments and can advise clients accordingly by performing thorough gap-analyses in the areas of Quality; Pharmacovigilance; Regulatory; Clinical; Medical Information; Marketing and Product Recalls.
We have performed this function globally for many Companies, as well as the training out of these SOPs once finalised. We have also helped Companies in establishing their whole SOP process for Pharmacovigilance, Regulatory, Clinical, Marketing, Product Complaints/Technical and Medical Services.
We also write Working Practice Documents (WPDs) to suit our client needs if their rationale is to have these as well as procedural manuals (e.g. User Manuals for Safety Database Usage).
SOPs are a vital part of the education, understanding and training of staff to perform activities in compliance with multi-national regulations and all of our processes reflect this requirement.
PharSafer® has helped companies in the preparation and assessment of Requests for Proposal (RFPs), User Requirement Specifications (URSs) and implementation of validated safety databases. Along with all of the accompanying documentation (OQ; IQ; PQ validation), SOPs on the management of the safety system, administration manuals, user manuals and back up and disaster recovery procedures, so as those companies could demonstrate that the database implementation was properly tested according to Regulatory requirements and supported by the necessary SOPs and manuals for its usage.
Our experienced team of safety and validation experts configure the data outputs from the database to ensure that you get the reports you want for easy database usage. We have been involved with multi-national implementations, which necessarily included considerations of the aspects of electronic reporting of adverse reactions to Competent Authorities including the EMA, USA and Japan.
PharSafer® has been involved in various different commercial safety database implementations. These have involved database mergers, database retirement activities while changing to a different database, safety data electronic transfers, training, writing user manuals and database upgrades.
All activities are supported by SOPs, template documents for verification of data transfers and execution of upgrades and implementations.
Due diligence is an essential activity, forming part of the process for any company purchase or for buying products from another Company.
Predominantly, such due diligence activities revolve around the commercial elements of the transaction and not always a consideration for the Pharmacovigilance status of the company.
It is absolutely essential to ensure the company is purchasing products with an up to date safety profile and has full knowledge of the potential safety risks associated with each of the products. There should be an in-depth understanding of the level of compliance and Pharmacovigilance activities of the company being purchased, to assess potential critical failures which may need correction or the aspects of integration that will be necessary in order to ensure a smooth transition of the Pharmacovigilance activities.
In Europe, for the Regulatory Authorities, product acquisitions/mergers/ and takeovers are potential triggers for a Pharmacovigilance Regulatory Inspection. This is because once the company has been acquired or the products/ licences purchased, as owner of the new company or products, you are now responsible and accountable for any aspects of the safety of the products including items that in the past may not have been done properly.
Over the years PharSafer® has seen many instances of inadequate due diligence exercise, resulting in critical findings in subsequent inspections, licence suspensions or delayed marketing of a product for up to a year for newly acquired products. All of which could have been avoided with proper activities being performed at the time of the due diligence.
PharSafer® can help companies of all sizes by providing interim services of staff on site for a variety of roles including: Data Entry personnel, Medical review of cases, Interim PV Managers, Auditors, Compliance Officers, Qualified Persons for Pharmacovigilance, all the way through to Senior Director Level. Temporary appointments can help while you select permanent staff, cover for maternity leave and sickness or just cover for a temporary heavy workload.
We offer flexible approaches to our Interim Services. Some of the contracts we have in place are for a period of two days per week for the next two years. Some contracts are initially for staff to work on site and then to work remotely in our own offices. There are many permutations available and we can be as flexible as clients require.
We also have links with multi-national recruitment companies, who specialise in interim positions, and have been selected as number one CRO for the supply of personnel by a leading interim service provider.