What is QPPV in Pharmacovigilance?

A Qualified Person for Pharmacovigilance (QPPV) has a very important role in ensuring patient safety and regulatory compliance within the pharmaceutical industry. This critical position is mandated by regulatory authorities worldwide, and its responsibilities are pivotal in safeguarding public health. A QPPV is a key person for regulatory agencies across the globe and pharmaceutical companies as they are the primary point of contact for pharmacovigilance-related matters.

Role and Responsibilities of QPPV?

A QPPV’s roles and responsibilities are multifaceted and demand a comprehensive understanding of pharmacovigilance (PV) regulations. For example, one of the many important duties of a QPPV is to establish and maintain a robust PV system within the pharmaceutical company. They must also help prepare PV reports in accordance with regulatory agency requirements, address safety-related queries and requests from global health authorities and provide them with any information relevant to product safety. A QPPV must also have an overview of the safety profile of drugs marketing in their respective country including any emerging safety data/concerns regarding a drug.

A QPPV must also ensure the timely and accurate submission of pharmacovigilance aggregate reports and other safety reports to regulatory agencies as per their requirement. These reports contain comprehensive and critical overview of the drug’s safety profile including emerging risks/safety concerns. A QPPV is also responsible for overseeing signal detection activities. These involve the systematic review of safety data to identify potential safety issues that may require further investigation. A QPPV must also liaise with regulatory authorities during audit and inspections. They ensure that a company’s PV system is compliant with the applicable regulations.

Generally, the requirements for a QPPV remain similar for global regulatory agencies. For example, an appointed QPPV must be available 24/7 to address PV and drug safety-related matters and should be medically qualified. However, while some regulatory authorities mandate the QPPV to be a resident of the country and be physically present (i.e., Saudi Arabia), others do not require this (i.e., Vietnam). Furthermore, there is also usually a need for a deputy QPPV in case the QPPV is unavailable.

DDReg’s Capabilities

DDReg has an extensive network of QPPVs that cover the entire globe and are available 24/7. They provide support with sign-off and updates to PSMFs, act as a contact point for PV audits and/or inspections, and in the review & submission of aggregate reports & RMPs. DDReg’s QPPVs provide support with local literature searches for journals & articles in required databases, and in the review & sign-off of MAAs, SDEAs, SOPs, aggregate reports etc. They also facilitate regulatory services and drug safety intelligence for emerging markets.

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