The TGA has released two consultation guidance documents to industry on the soon-to-be implemented Pharmacovigilance(PV) Inspection programme applicable to the Australian therapeutic industry.
The TGA are conducting workshop sessions in 3 major cities TGA Pharmacovigilance Inspection Program: Information Sessions.
Please contact Biotech Regulatory Solutions to discuss your companies needs and readiness for TGA PV Inspections. We have an array of experienced consultants in QA, PV and regulatory affairs to provide gap analysis/audit readiness reports and solutions for your company.