The Qualified Person for Pharmacovigilance (QPPV) is an individual personally responsible for a Pharmaceutical company/Marketing Authorization Holders adherence to the legal requirements for drug safety activities. These activities include safety surveillance, reporting, quality system, documentation, training and benefit/risk assessments.
GLOBAL DRUG SAFETY AND PHARMACOVIGILANCE
SERVICES – REPORTING – DATABASES – RISK MANAGEMENT – INFORMATION – CONSULTING
The revised regulations for the European Union now has a requirement for a Marketing Authorization holder to maintain a document with all information relevant for safety of a marketed product. It is the responsibility of the QPPV that the Pharmacovigilance Master File is complete and always up to date. Technically it is normally not one physical document but an framework with components maintained in different repositories and systems. However it as to be available for inspection at anytime.
A pharmaceutical company is required to perform internal audits of the Quality Management system related to drug safety. These audits are intended to confirm that a necessity components including policies, procedures, guidelines, validations and training are conforming wil global requirements and that they are appropriately documented. In most countries there are an expectation that all parts of the drug safety organization and process is audited internally at least every two years
Expedited reporting is at the core of Pharmacovigilance and Drug Safety. Timely processing, correct coding and medical review is critical for regulatory compliance as well as company understanding of product risks. The expedited reports is the basis for safety surveillance activities that include Signal Detection and Risk/Benefit Assessments.
Periodic Reporting to Regulatory Agencies, Ethics Committees are absolute requirements. Periodic Benefit Risk Evaluation Reports (PBRERs) reports for marketed products and Development Safety Update Reports (DSURs) for development products must be submitted in most jurisdictions. But some countries have their own requirements like the FDA required PADER report and the European QSURs and SSURs to Investigators and Ethics Committees.
Formal Risk/Benefit assessments have become an integral part of all periodic reporting in the form of PBRER post marketing reports and DSUR reports related to clinical development. In these reports it is required to assess the known Risk/Benefit profile for the drug and propose actions necessary to clarify any potential changes to the Risk/Benefit profile. Apart from the periodic reports; Risk/Benefit analysis should also be an integral part of day to day business in the drug safety function of any Pharmaceutical company
Collecting information about pregnancies is not new and the requirements for collection of data was imposed after the Thalidomide disaster in mid 60′, but of often it is unclear how to interpret a few cases of malformations. Regulators have a tendency to stay cautious and take a drug of the market if there is any indication fetal safety issues. A proactive approach to pregnancy surveillance can save both patients, products and the company when done right and early.
Data Privacy is quickly becoming one of the most important and complicated issues for the pharmaceutical industry. The laws are often unclear, contradictory and vastly different around the globe. Conducting clinical development while maintaining compliance with Data Privacy regulations require a substantial and focused effort. Despite the unclear requirements – Failure to comply has severe implications for companies and responsible staff.
Safety reports are constantly coded and added to the safety database. All this data is the bases for identification of new potential safety issues with your products. Effective tools to search the database and identify useful signals is essential to keep the product safe and for you to know before the regulatory agencies start asking the critical questions.
A team of experts with experience in all aspects of Global Drug Safety and Pharmacovigilance is available to support you with consulting or information services tailored to your particular need.