---
title: Blog | Paola Cinquanta
description: Regulatory Affairs Operations Unit Manager @PQE Group
---

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# Paola Cinquanta

#### Regulatory Affairs Operations Unit Manager @PQE Group

[Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/)

# **Latest Insights**

[Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/Reform%20EU%20Commission_Site_PQE-1.jpg)](https://blog.pqegroup.com/ra-phv/reform-pharmaceutical-sector-eu-commission)

30 Jun 2023

## [Reform of the pharmaceutical sector by the EU Commission At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right.](https://blog.pqegroup.com/ra-phv/reform-pharmaceutical-sector-eu-commission)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/ra-phv/reform-pharmaceutical-sector-eu-commission&title=Reform%20of%20the%20pharmaceutical%20sector%20by%20the%20EU%20Commission&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Reform%20EU%20Commission_Site_PQE-1.jpg&description=At%20the%20end%20of%20April%202023,%20the%20EU%20Commission%20announced%20the%20largest%20reform%20of%20the%20pharmaceutical%20sector%20in%20over%2020%20years.%20Why%20is%20this%20happening%20right%20now,%20and%20what%20should%20we%20expect%20from%20pharmaceutical%20legislation> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/ra-phv/reform-pharmaceutical-sector-eu-commission&title=Reform%20of%20the%20pharmaceutical%20sector%20by%20the%20EU%20Commission&summary=At%20the%20end%20of%20April%202023,%20the%20EU%20Commission%20announced%20the%20largest%20reform%20of%20the%20pharmaceutical%20sector%20in%20over%2020%20years.%20Why%20is%20this%20happening%20right%20now,%20and%20what%20should%20we%20expect%20from%20pharmaceutical%20legislation> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Reform%20of%20the%20pharmaceutical%20sector%20by%20the%20EU%20Commission&url=https://blog.pqegroup.com/ra-phv/reform-pharmaceutical-sector-eu-commission)

[GxP Compliance ![](https://blog.pqegroup.com/hubfs/Entering%20the%20EU%20Market_Site%20PQE-1.jpg)](https://blog.pqegroup.com/gxp-compliance/entering-the-eu-market-of-generics-products-registration-dos-and-donts)

26 Apr 2023

## [Entering the EU Market of generics: products’ registration, do’s and don’ts How to register a generic medicine in the European market?](https://blog.pqegroup.com/gxp-compliance/entering-the-eu-market-of-generics-products-registration-dos-and-donts)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/gxp-compliance/entering-the-eu-market-of-generics-products-registration-dos-and-donts&title=Entering%20the%20EU%20Market%20of%20generics:%20products’%20registration,%20do’s%20and%20don’ts&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Entering%20the%20EU%20Market_Site%20PQE-1.jpg&description=How%20to%20register%20a%20generic%20medicine%20in%20the%20European%20market> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/gxp-compliance/entering-the-eu-market-of-generics-products-registration-dos-and-donts&title=Entering%20the%20EU%20Market%20of%20generics:%20products’%20registration,%20do’s%20and%20don’ts&summary=How%20to%20register%20a%20generic%20medicine%20in%20the%20European%20market> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Entering%20the%20EU%20Market%20of%20generics:%20products’%20registration,%20do’s%20and%20don’ts&url=https://blog.pqegroup.com/gxp-compliance/entering-the-eu-market-of-generics-products-registration-dos-and-donts)

[Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/EU%20Road_banner%20insight.jpg)](https://blog.pqegroup.com/ra-phv/regulatory-systems-interoperability)

04 Oct 2022

## [The EU Road to reach interoperability across regulatory systems: are you in step with the new EMA standards and regulatory systems? The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.](https://blog.pqegroup.com/ra-phv/regulatory-systems-interoperability)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/ra-phv/regulatory-systems-interoperability&title=The%20EU%20Road%20to%20reach%20interoperability%20across%20regulatory%20systems:%20are%20you%20in%20step%20with%20the%20new%20EMA%20standards%20and%20regulatory%20systems?&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/EU%20Road_banner%20insight.jpg&description=The%20Life%20Science%20industry%20revolution%20goes%20along%20with%20the%20development%20of%20data%20interoperability%20systems%20that%20allow%20shared%20data%20within%20the%20entire%20spectrum%20of%20care.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/ra-phv/regulatory-systems-interoperability&title=The%20EU%20Road%20to%20reach%20interoperability%20across%20regulatory%20systems:%20are%20you%20in%20step%20with%20the%20new%20EMA%20standards%20and%20regulatory%20systems?&summary=The%20Life%20Science%20industry%20revolution%20goes%20along%20with%20the%20development%20of%20data%20interoperability%20systems%20that%20allow%20shared%20data%20within%20the%20entire%20spectrum%20of%20care.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=The%20EU%20Road%20to%20reach%20interoperability%20across%20regulatory%20systems:%20are%20you%20in%20step%20with%20the%20new%20EMA%20standards%20and%20regulatory%20systems?&url=https://blog.pqegroup.com/ra-phv/regulatory-systems-interoperability)

[Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/100%20Generic%20Medicines_banner%20insight%20sito.jpg)](https://blog.pqegroup.com/ra-phv/clinical-data-integrity-issues)

09 Jun 2022

## [100 Generic Medicines Suspended due to Clinical Data Integrity: How to secure your business and ensure your clinical data is valid EMA has recommended the suspension of around 100 generic drugs for Data Integrity and Reliability issues, with the consequence of repeating the.](https://blog.pqegroup.com/ra-phv/clinical-data-integrity-issues)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/ra-phv/clinical-data-integrity-issues&title=100%20Generic%20Medicines%20Suspended%20due%20to%20Clinical%20Data%20Integrity:%20How%20to%20secure%20your%20business%20and%20ensure%20your%20clinical%20data%20is%20valid&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/100%20Generic%20Medicines_banner%20insight%20sito.jpg&description=EMA%20has%20recommended%20the%20suspension%20of%20around%20100%20generic%20drugs%20for%20Data%20Integrity%20and%20Reliability%20issues,%20with%20the%20consequence%20of%20repeating%20the%20bioequivalence%20studies.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/ra-phv/clinical-data-integrity-issues&title=100%20Generic%20Medicines%20Suspended%20due%20to%20Clinical%20Data%20Integrity:%20How%20to%20secure%20your%20business%20and%20ensure%20your%20clinical%20data%20is%20valid&summary=EMA%20has%20recommended%20the%20suspension%20of%20around%20100%20generic%20drugs%20for%20Data%20Integrity%20and%20Reliability%20issues,%20with%20the%20consequence%20of%20repeating%20the%20bioequivalence%20studies.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=100%20Generic%20Medicines%20Suspended%20due%20to%20Clinical%20Data%20Integrity:%20How%20to%20secure%20your%20business%20and%20ensure%20your%20clinical%20data%20is%20valid&url=https://blog.pqegroup.com/ra-phv/clinical-data-integrity-issues)

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