The Role of the QPPV in Pharmacovigilance Obligations
The increasing number of small and medium enterprise sponsors who register therapeutic goods means that an ever-growing number of staff within sponsor companies must know about the importance, and by extension, the responsibilities of pharmacovigilance (PV), or ‘drug-safety’. The collection, detection, analysis, and reporting of safety events for any company is paramount to the effectiveness of the PV system and the ongoing benefit-risk profile of its registered products.
Regulatory Compliance and QPPV Responsibilities
The PV system is overseen by a ‘Qualified Person for Pharmacovigilance’, or QPPV. The role of the QPPV is to ensure that a robust and functional system for PV activities is in place. The responsibility for the function of the system lies with the QPPV, however, all staff are responsible for pharmacovigilance reporting. The QPPV is a legal requirement for companies and is a condition of registration for products. Depending on the jurisdiction, the QPPV may be required to be a nominated person resident in that particular jurisdiction. For instance, in Australia, the QPPV and nominated Deputy QPPV must be qualified persons residing in Australia. But simply nominating individuals to act as QPPV or Deputy QPPV is not sufficient. The TGA and other global regulators are holding the QPPV to an increasingly higher standard of both qualifications and oversight.
As therapeutic products, including personalised healthcare, medical devices, and software, become more specialised, the scope and oversight of PV activities are expanding. The TGA recently announced the initiation of device vigilance inspections through a forthcoming pilot program.
From clinical trials and protocol design to the registration and adherence of regulatory commitments for new medications, robust pharmacovigilance systems and processes are already and will continue to be a prerequisite for market entry.
Throughout the product’s lifecycle, the ongoing monitoring, assessment and reporting of adverse events is a key requirement for sponsor companies, covering activities such as changes in Product Information, ensuring and communicating the ongoing benefit-risk profile of products, as well as the creation of promotional and educational materials for patients and HCPs alike.
Ongoing investment in the systems and processes to support these requirements can be a significant investment, however the cost for failure to do so can be significantly higher, with regulatory authorities having the agency to impose additional restrictions on sponsors, as well as cancel registration of sponsors and their products.
Through our involvement in both the industry landscape, and through the continued questions we receive as queries and in person at industry events, there is still sufficient gaps in the knowledge and PV education that is expected for existing QPPVs as well as for new sponsors entering the environment, as highlighted by the number of QPPV related findings within the TGA PV Inspection Program.
Enhancing Patient Safety Through Comprehensive PV Services & QPPV Support by Commercial Eyes
At Commercial Eyes, we provide a comprehensive PV services to sponsor companies that includes acting as QPPV or Deputy QPPV. We have participated in 10 TGA inspections, and are up-to-date with the TGA expectations from the QPPV. As part of our PV service, we are audited by over 30 companies each year, with no critical findings. Acting as QPPV and Deputy QPPV gives our clients peace of mind that the activities requiring QPPV oversight are delivered effectively and efficiently, saving both headcount and the potential headache of findings by the TGA.
To learn more about how Commercial Eyes can support and improve your Patient Safety system and activities, including providing you with essential QPPV or Deputy QPPV representation, please contact Lorenza Ricacho, Regional Head of Patient Safety at [email protected].