Harefield PV

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Harefield Pharmacovigilance offers fully comprehensive services for European pharmacovigilance requirements.

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Type Public / Private

Our company aims to tailor services efficiently according to the individual requirements of each client.

We aim to work with each client as a team to optimise compliance under the regulations and efficiency and economy in operation.

Our services include the provision of full European QP Pharmacovigilance cover, overview of company needs and tailored design of Pharmacovigilance Systems. The full range of our services can be found at Services.

We also offer full regulatory support through our partner company Harefield Pharma Associates Limited.

Our organisation client-related focus on pharmacovigilance challenges allows us to deliver robust systems at competitive costs.

Services Offered

Pharmacovigilance Master File - This is undertaken after a careful review of the client’s existing structure and procedures so that the Pharmacovigilance system is appropriate to the company rather than a “one size fits all” approach. The aim is to achieve a straightforward workable system which is robust in pharmacovigilance outcomes and efficient in cost.

Pharmacovigilance QP Services - The full services of a Pharmacovigilance QP and backup are available. The QPPV role is closely integrated with medical and quality assurance advice.

Processing of Suspected Adverse Reaction Reports, Report Monitoring and Expedited Reporting - Harefield takes responsibility for the medical review and subsequent handling of spontaneous reports to the company and is used to working with other third parties which may be used to handle medical information enquiries.

Literature Searches with Medical Review- This part of routine pharmacovigilance is handled by medically or pharmaceutically qualified staff to give a high quality service with early recognition of any potential information of interest and integration with signal generation.

Signal Generation and Drug Safety Profile and Risk - Benefit Analysis - Medical review is undertaken of all company products on a continuing basis with three monthly reviews to detect and evaluate potential safety signals.

Periodic Safety Update Reports - These are undertaken in timely fashion whenever required.

Signal Evaluation and Risk Management - Any signal identified from routine pharmcacovigilance will be evaluated and any likely impact on the safety or benefit risk of the product will be notified to the company with clear recommendations on possible appropriate action.

Training of Staff in Pharmacovigilance Procedures - Training on pharmacovigilance is usually supplied annually and is tailored on a company by company basis for all levels of staff experience and with records of training supplied.

Eudravigilance Registration for Client Companies - This is undertaken as required.

Clinical Trials - Drug Safety - Harefield Pharmacovigilance has experience of and processes for safety monitoring in clinical trials in Europe.

Devices and Specials Supplies - Support for the safety monitoring as required under European and UK regulations for these supplies is provided.

Company Pharmacovigilance Audits and Preparation for Regulatory Inspections - Audits of pharmacovigilance processes have been conducted throughout Europe and in other continents throughout the world.


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