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PvNET Pharmacovigilance software & Drug Safety Database

PvNET- Pharmacovigilance Software and Drug Safety Database - An excellent risk management tool compliant with ICH E2B and other regulatory guidelines,

http://pvnet.sarjen.com/

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PvNET- Pharmacovigilance Software and Drug Safety Database - An excellent risk management tool compliant with ICH E2B and other regulatory guidelines,
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PvNET Pharmacovigilance software & Drug Safety Database | pvnet.sarjen.com Reviews

https://pvnet.sarjen.com

PvNET- Pharmacovigilance Software and Drug Safety Database - An excellent risk management tool compliant with ICH E2B and other regulatory guidelines,

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pvnet.sarjen.com pvnet.sarjen.com
1

Australian Guideline For Pharmacovigilance Responsibilities

http://pvnet.sarjen.com/regulatories/others/australia

As a Service (On-Cloud). As a Solution (On-Premise). Australia: (Australian Guideline For Pharmacovigilance Responsibilities Of Sponsors Of Registered Medicines Regulated By Drug Safety And Evaluation Branch). Each sponsor of registered medicines must ensure that it has an appropriate system of pharmacovigilance in place in order to assure responsibility and liability for its products on the market and to ensure that appropriate action can be taken, when necessary. The sponsor should have permanently and...

2

Russian Guidelines: Federal service of surveillance

http://pvnet.sarjen.com/regulatories/others/russia

As a Service (On-Cloud). As a Solution (On-Premise). Russian Guidelines: Federal service of surveillance in Health and Social development. Marketing authorization holders have to create and put into practice an effective in-house pharmacovigilance system. A Detailed Description Of Their Pharmacovigilance System. Automatic Electronic System for submission data about adverse reactions (AES). PSUR for all products approved for medical use on the territory of the Russian Federation (originals and generics).

3

Product Registration (xEVMPD, EVPRM) module

http://pvnet.sarjen.com/pharmacovigilance/xevmpd

As a Service (On-Cloud). As a Solution (On-Premise). As part of a new legislation, EMA requires under article 57 (2), the establishment of a list of all human medicines authorised in the EU, based on structured XML’s submitted by Marketing Authorisation Holders. The objective being clear identification of medicines in reports on Adverse Reactions. This is a considerable challenge as xEVPRM requires information on:. Expressions systems for biologicals/biotechnological derived substance. PvNET xEVMPD modul...

4

Ministry of Health of Ukraine

http://pvnet.sarjen.com/regulatories/others/ukraine

As a Service (On-Cloud). As a Solution (On-Premise). Ministry of Health of Ukraine. Manufacturer/applicant (or its representative) should ensure functioning of the appropriate system for collecting, evaluating and submitting of any data necessary for assessing risks and benefits of the medical use of a medicinal product, which is an obligatory condition for the presence of a medicinal product on Ukraine’s pharmaceutical market. Ministry of Health of Ukraine. Manufacturer/applicant (or its representative)...

5

EMA Legislation responsibilities for Pharmacovigilance

http://pvnet.sarjen.com/regulatories/ema

As a Service (On-Cloud). As a Solution (On-Premise). EMA Legislation imposes responsibilities for Pharmacovigilance together with specific obligations in terms of tasks and responsibilities on Marketing Authorisation holders. New Regulations increase public participation by giving rights to individual EU citizen to report suspected adverse reactions directly to competent authorities and Market Authorisation Holders. Designed by pharmacovigilance experts. Cost effective pharmacovigilance solution. Auto na...

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LINKS TO THIS WEBSITE

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Brochures of all products of Sarjen Systems Pvt. Ltd.

http://www.sarjen.com/company/downloads/brochures

Sarjen @ a Glance. Cross Platform Responsive Design. Portals, CMS and eCommerce. Pharma and life science industries. Project Tracking and Timesheet Management. Pharmacovigilance and Safety Database. Corporate details with a glimpse of Sarjen’s abilities, expertise and experience its solutions, services and more. Click here for detail. Details of a web based but any smart device compatible, comprehensive sales force automation and effectiveness and CRM software solution. Click here for detail. Click here ...

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Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software - Business, Regulatory solutions and services by Sarjen

http://www.sarjen.com/solution

Sarjen @ a Glance. Cross Platform Responsive Design. Portals, CMS and eCommerce. Pharma and life science industries. Project Tracking and Timesheet Management. Pharmacovigilance and Safety Database. Pharmacovigilance and safty database. Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software. Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software. Pharmacovigilance and safty database. History of PADER/PAER submission:. FDA recei...

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