Following a successful pilot program conducted in 2015-16, the Therapeutic Goods Administration's (TGA's) Pharmacovigilance Inspection Program (PVIP) has been implemented as an initiative to help sponsors of medicines to meet their pharmacovigilance obligations.
SeerPharma is helping sponsors prepare for the inspections.
The TGA applies a risk management approach to ensuring that medicines included on the Australian Register of Therapeutic Goods (ARTG) meet acceptable standards of quality, safety and efficacy, and are subject to ongoing monitoring to ensure that these standards are maintained.
The PVIP Risk Assessment Survey has been open since 31 January 2018 for medicine sponsors to complete and closes at the end of this month (31st March 2018). Medicine sponsors that do not complete this survey will be assigned the highest survey risk score. The survey risk score will be combined with other risk information to help prioritise and schedule TGA pharmacovigilance inspections.
Sponsors will be given six to eight weeks' notice prior to an inspection taking place.
Not sure if you're ready?
As a Sponsor, you can leverage SeerPharma's expertise to help prepare your organisation for a TGA pharmacovigilance inspection. Whether you're looking for Consulting support (e.g. a gap analysis and remediation plan) or Training (to upskill your staff and help them deliver on the requirements), SeerPharma can help.
Areas we are helping clients include:
- Development/Review and advice on internal or third-party organisation policies and procedures regarding pharmacovigilance activities
- Design and implementation of Quality Management Systems to best-handle data on adverse event cases, product safety and pharmacovigilance activities
We have also extended this support to helping pharmaceutical companies establish compliance with related Pharmaceutical Quality System requirements of the PIC/S Guide to GMP (version 13) while optimising their business processes and operations. Submit the webform below to see an example flowchart for Customer Feedback.
Contact us if you'd like to discuss your needs or concerns and explore how SeerPharma might be able to help.