Pharmacovigilance Template Pack

Pharmacovigilance Template Pack

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$1,000.00 US

This Pharmacovigilance Template pack is designed to be a simpler version of full-scale Pharmacovigilance systems for high-risk products. It is a good base for starting up a Pharmacovigilance system before adding further layers of complexity (as per your organisation’s requirements).

SKU: pv-templates Category:

Description

This Pharmacovigilance Template pack is designed to be a simpler version of full-scale Pharmacovigilance systems for high-risk products. It is a good base for starting up a Pharmacovigilance system before adding further layers of complexity (as per your organisation’s requirements).

It is suitable for companies that deal with lower risk complementary medicines and prescription drugs that do not currently have a Pharmacovigilance system in place

The Pharmacovigilance Template pack is designed to meet the EMA/816/2011 revision 1 adopted by the TGA in April 2014.

This Pharmacovigilance Template pack is not suitable for:

  • organisations that are running clinical trials, manufacture higher risk products or manufacture medical devices
  • companies with registration conditions imposed under section 28(2B) of the Act and required to provide Product Safety Update Reports (PSURs). If you manufacture products under this condition, on top of the PV documents already provided in this pack, you will need to design additional PSUR review and reporting SOPs to comply with the conditions in your TGA licence. (The requirements for the aggregate report are described in the European guideline EMA/816292/2011, Guideline on good pharmacovigilance practices (GVP), Module VII – Periodic safety update report.)

PharmOut offers 1-hour free phone or email support with the purchase of the documents within 12 months of the purchase date. Please quote the reference number included with the document purchase invoice.

Additional support is available upon request if further help is required.


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