EV MPD (Eudravigilance Medicinal Product Database)
In Europe there is a requirement to register your Company products (both clinical and post-marketing) onto the Eudravigilance product dictionary database. This is also a service that PharSafer® can provide for you cost effectively.
We have SOPs and trained staff in entering and maintaining your Company product details onto the EVMPD to maximize your compliance.
Standard Operating Procedure (SOP) Writing
PharSafer® have a complete suite of our own SOPs to accommodate all of the activities we perform for our clients. These SOPs can be scrutinized 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.
Clients wishing to formalise their own procedures (in-house) have also utilised our services for SOP writing in order to have simple, effective SOPs that accurately describe their processes. Due to our extensive knowledge of Regulatory Inspections we are well aware of what written processes the Regulatory Authorities expect to see as part of their assessments and so can advise clients accordingly by performing thorough gap-analyses.
We have performed this function for many Companies globally as well as the training out of these SOPs once finalized. We have also helped Companies in establishing their whole SOP process not just for Pharmacovigilance, but also Regulatory, Clinical, Marketing, Product Complaints/Technical and of course Medical Services.
According to client needs we also write Working Practice Documents (WPDs) if their rationale is to have these as well as procedural manuals (e.g. User Manuals for Safety Database Usage).
Database implementations
PharSafer® has helped Companies in the assessment (Requests for Purchase, (RFP): User Requirement Specification, (URS) and implementation of validated safety databases and all accompanying documentation (OQ; IQ; PQ validation); SOPs on the management of the safety system; administration manuals; User manuals; back up and disaster recovery procedures so that Companies can demonstrate that the database implementation has been properly tested according to Regulatory requirements and supported by the necessary SOPs and manuals for its usage.
The implementations have been multi-national and with our experienced team of safety and validation experts to help with configuring the data outputs from the database we can ensure that you get the reports you want for easy database usage.
The implementations have also included the aspects to consider for the electronic reporting of adverse reactions to Competent Authorities which includes the EMEA; USA and Japan.
PharSafer® has been involved in different commercial database implementations at Companies which have involved database mergers; database retirement activities while changing to a different database; safety data electronic transfers; training; and database upgrades.
Due Diligence
An essential part of any assessment for either the purchasing of products or Companies for a Pharma Company is the activity of Due Diligence.
This is often an area that is not considered to involve the area of Pharmacovigilance but 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 the product, all the way through to an understanding and assessment when buying a Company of the level of compliance and pharmacovigilance activities of the Company being purchased to assess potential critical failures that will need correction or the aspects of integration that will be necessary in order to ensure a smooth transition of pharmacovigilance activities.
In Europe, the Regulatory Authorities both product acquisitions/mergers/ and takeovers are potential triggers for a Regulatory Inspection for Pharmacovigilance.
Interim Services
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 reviews of cases; interim PV Managers; Auditors; Compliance Officers; Qualified Persons for Pharmacovigilance all the way through to Senior Director level temporary appointments that can help while you select permanent staff; cover for maternity leave or sickness or just cover for a temporary heavy workload.
Some of the contracts we have in place are with Companies for a period of 2 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. The permutations are endless but our flexibility to help you is not.
We also have links with multi-national Recruitment Companies who specialise in interim positions and have been selected as number one CRO by a leading interims provider for the supply of our people too.