Your shopping cart


Total (VAT incl.)

VAT (21%)
You have not added any reports to the cart yet.
Request reports
If you prefer to place your order via e-mail
contact us at: digital@azierta.com

Events and news


Updated guidance on pharmacovigilance procedures

On September 1st, the Medicines and Healthcare products Regulatory Agency (MHRA) published a pharmacovigilance update for...

Read more

Development Update Safety Report

According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies...

Read more

Development Safety Update Report (DSUR)

In September 2010, the International Conference Harmonisation developed the ICH E2F Guideline for the Development Safety...

Read more

Periodic Benefit-Risk Evaluation Report (PBRER)

According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders...

Read more

Risk Management Plan: GVP Module V

European Medicines Agency published Module V of Good Vigilance Practices in 2012 and it was later revised in April 2014....

Read more

Pilot extension in EVDAS

The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor...

Read more

GVP Módulo II: Pharmacovigilance System Master File

Las Buenas Prácticas de Farmacovigilancia (Good Pharmacovigillance Practices – GVP) publicadas por la EMA constituyen la...

Read more

EMA proposed changes to preparation of risk management plans....

In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice...

Read more

Keys for adapting to the new Pharmacovigilance Environment

At the end of 2017, a new version of Eudravigilance went online to manage suspected adverse reactions to medicines. This...

Read more

RMP changes to GVP Module V- A doorway to better risk-oriented,...

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice...

Read more

Addendum to the clinical overview

The addendum to the clinical overview collects all cumulated effectiveness and safety data related to a medicinal product...

Read more

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

Thank you for getting in touch! We will contact you as soon as possible to help you out
There has been an error while submitting your form, please try again, or call us at 912 77 10 76
Schedule appointment

Schedule a video call with our field experts

We use "cookies" to improve your experience on our site. Cookies enable us to tailor messages and display ads to your interests. They also help us understand how our site is being used. By continuing to use our site you consent to use our cookies.