Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build a Quality Management System (QMS) for ISO, GMP or other regulatory compliance.
The templates are used by our consultants in the field and are full of practical guidance and how-to instructions.
They are easy to use and will save you weeks, if not months, of time. Ideal for startup pharmaceutical or life science companies who must comply with TGA or FDA GMP guidelines.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
Pharmacovigilance Template Pack
USD $1,000.00
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).
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
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.
You may also like…
Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build your computer system validation protocols.
The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.
Ideal for startup pharmaceutical or life science companies who must comply with PIC/S (TGA) or FDA GMP guidelines.
We offer a simple series of templates that can be scaled to suit your validation needs.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
Do it yourself ISO 13485 or QSR 820 compliance
Built in Microsoft® Word for easy editing, these medical device QMS templates are the quick and easy way to build a Quality Management System (QMS) compliant with the ISO 13485 standard or QSR 820 regulations.
The medical device QMS templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.
Ideal for medical device companies who are preparing to commence manufacture of devices controlled by the FDA, TGA or any other regulatory authority.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.