Typical PharSafer® Projects
Case 1
Multinational generics Company
The Company, located outside of the EU, had a number of licences in the EU (and outside) and no pharmacovigilance activities. Many of the products were commercialised via distribution partners. The Company had just been contacted by a Regulatory Agency for a full Pharmacovigilance Inspection.
PharSafer® was approached to become the Company’s full service provider for Pharmacovigilance and Medical Services. Immediately, PharSafer® sat down with the client and produced a Project plan that took care of all of the current requirements for safety reporting (Eudravigilance registration, setting up literature searches, advising on faxing over all ADRs from distributors as well as a retrospective check of potential missed cases, literature searches, PSURs, safety reviews and a consolidation of the Company SPCs especially because the Company had no Core Safety Information.
PharSafer® then prepared documentation for electronic reporting, registration of our own QP for Pharmacovigilance and Deputy together with submitting safety reports that had been missed and PSURs and liaising with the Agency as the Inspection approached. Seven staff members worked for 8 weeks continuously (including Pizza weekends!) to get the client into a compliant position in readiness for the Inspection and although not all activities had been fully completed (we were about 90% with having everything resolved) we managed to ensure the client had no critical findings and the Regulators were able to see we had produced a compliant pharmacovigilance system for the client moving forward as we had all safety reporting plans, PSUR schedules, core safety information complete and compliance statistics now operating as well as safety agreements with the distributors.
Case 2
Multi-National Company – First product to Market
PharSafer® worked with a ‘first product to market’ Company launching their first development product in Europe and the USA. PharSafer® were involved with the clinical trial safety of the product through phases II and III; production of the safety sections of the Common Technical Document (CTD); production of the DDPS and Risk Management Plan Strategy for the licence submission that occurred both in the USA and EU. PharSafer® was selected as the full service provider for the Company and is now, following licence approvals in both regions, operating for multi-national safety reporting in the USA and Europe for the client Company as well as serving as EU QP PV and Deputy.
Case 3
EU Biotech Company – advanced therapies product in multi-national clinical trials
PharSafer® was approached to be the CRO for safety monitoring for an advanced therapy being developed in the EU with multi-national clinical trials. Due to the nature of the product and the type of disease, an Independent Data Monitoring Committee (IDMC) is in place and PharSafer® are responsible for the submission of SUSARs; Annual Safety Reports, reports for the Ethics Committees and provision of safety data for the IDMC as well as independent signal detection and benefit-risk assessments.
Case 4
Expanding USA Headquartered Company – EU Acquisitions
A USA Company was wanting to expand the Company into the EU market and was in the process of purchasing another Pharma Company with affiliates in the EU. PharSafer® was asked to perform a Due Diligence exercise of the Company to verify the pharmacovigilance systems in place and compliance levels within the Company in order to ensure that the acquiring Company had confidence that the marketed products had been managed correctly in terms of compliance to legislation, benefit-risk assessments; procedures; PSURs; so that the Company was aware of any potential safety issues.
PharSafer® was then responsible for helping with the integration processes with the parent Company.
Case 5
Multi-National Company – Critical Inspection findings
A multi-national Company approached PharSafer® following a Regulatory Pharmacovigilance Inspection in which there were critical findings and major findings in different parts of the Company Safety system.
PharSafer® were involved in producing the Corrective Action Plans and overseeing a number of aspects of the Inspection findings, including SOP writing; training; PSUR writing; data entry activities; literature searching and setting up the signal detection methodology.
PharSafer® staff were on site in various capacities for over five months to rectify the deficiencies and ensure activities were working properly prior to the re-Inspection.