Pharmacovigilance (PV) as defined by the World Health Organization (WHO) is the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem". Of course, an adverse incident can also occur in relation to all products used in healthcare including medical devices and diagnostics.
An adverse effect or adverse drug reaction (ADR) is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as "an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs, and is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be new and previously unrecognised".
An adverse incident involving an healthcare product is defined by the MHRA as “an event that caused, or almost caused, an injury to a patient or other person or a wrong or delayed diagnosis and treatment of a patient”
Via a strategic partner, GRS can provide companies with a complete Pharmacovigilance Package which includes the following:
- Trained pharmacovigilance personnel with international experience (including senior safety physicians)
- Qualified Person (QP)
- Assistance with Health Authority inspections
- PSUR writing; Clinical Expert Reports; Risk Management Plans and Pharmacovigilance Plans for licence submissions
- Auditing of pharmacovigilance activities (including affiliates, distributors and for due diligence purposes)
- Weekly literature searches for Adverse Drug Reactions (ADRs)
- International expedited reporting (including electronic reporting)
- Safety reviews and signal detection
- Core safety preparations
- Compilation of a portfolio of Frequently Asked Questions (FAQs) etc using a validated medical information database
- Client access to a validated safety database
- Training for all levels of Pharmacovigilance
Please contact us with your specific regulatory compliance requirements.