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Events and news

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AZIERTA CONSULTANCY and CPQ INGENIEROS sign an alliance in the...

The Alliance will design a joint offer at a consulting level for the design of installations in pharmaceutical plants, participating...

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Updated guidance on pharmacovigilance procedures

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

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AZIERTA CONSULTANCY AND GTF MERCÉ CAMPS SIGN A STRATEGIC ALLIANCE...

The Alliance will be a leader in the Healthcare Consulting sector in this area.

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AZIERTA LAUNCHES THE "PRO-BONE-COVID-19 PROGRAM"

The consultancy firm AZIERTA provides Spanish and European researchers with its resources to promote the fight against the...

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How to proceed with an active ingredient that can be effective...

Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend...

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Polymeric materials in manufacturing processes: a new theat...

In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic...

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Accessing the EU Market: Becoming a suitable CMO for Europe...

Pharmaceutical companies are faced with the need to outsource the manufacturing processes of their products for a variety...

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Azierta provides comprehensive support to obtain the European...

At Azierta, we are experts in developing turnkey projects to optimize time and resources to capitalize on European business...

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Interview with Paulino Alonso: ICHQ3D on Elemental impurities...

ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use,...

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Webinar on ICHQ3D (Elemental Impurities)

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in the human medicines. Deadline...

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Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a...

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Accessing the European Pharma Market: becoming a MAH through...

Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s...

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Biotechnology: Incentives of the Advanced Medicinal Products...

What are Advanced Therapies? Advanced-therapy medicines are medicines that are made from genes and cells. They may offer...

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Cranberry Products are not Medical Devices

The European Commission has finally adopted in August 2017 the DECISION (EU) 2017/1445 on the qualification of cranberry...

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Key aspects in the implementation of directive ICH Q3D

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. But there...

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What are the Occupational Exposure Limits and why are they important?...

Chemical substances are being increasingly used in different sectors, including the pharmaceutical one. Thousands of these...

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Development Update Safety Report

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

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Development Safety Update Report (DSUR)

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

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Accessing the EU Market: Becoming a suitable CMO for Europe...

In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded...

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How to Identify extractables and leachables Impurities

The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However,...

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Periodic Benefit-Risk Evaluation Report (PBRER)

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

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Safety Reports: The importance of high quality content from...

The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the...

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Environmental Risk Assessment. ERA reports

The environmental risk assessment process for a medicinal product is complex. It is based on overall usage, destination...

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Phases in the evaluation of the occupational exposure to a chemical...

The aim of the hazard assessment is to determine the classification and labelling of the substance and to establish the...

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Polymeric materials in manufacturing processes: a new theat...

The range of polymeric materials available in the industry is very broad and materials have been developed with very different...

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Organic impurities: ICH Q3A AND ICH Q3B

Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical...

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New EU Medical Devices Regulation

Since 2012 the European Union (EU) has been working on the improvement and modernizing of the EU rules on medical devices...

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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....

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Toxicological assesments using (quantitative) structure-activity...

When assessing pharmacological and toxicological profile of chemical structures, several approaches are possible, including...

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Key factors for the implementation of directive ICH and Q3D...

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Economic impact of the pharmaceutical industry in EU

Large, diversified and global, the Pharmaceutical Industry is one of the most competitive sectors in the European economy....

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PDE calculation in shared facilities for veterinary medicaments...

On June 2016 will be coming into effect for veterinary medicaments EMA’s guideline (EMA/CHMP/CVMP/SWP/169430/2012) already...

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Phases in the evaluation of the occupational exposure to chemical...

After the banding control has been established along with the strategies to be followed, it is necessary to carry out a...

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Pilot extension in EVDAS

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

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Extractable and Leachable Impurities Regulation

The loss of quality of the medication due to the presence of extractables and leachables added to the risk that these impurities...

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GVP Módulo II: Pharmacovigilance System Master File

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

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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...

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Extractable and Leachable Impurities

Depending on their chemical nature and migratory properties from the container to the medium, these types of organic or...

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Accessing the European Pharma Market: becoming a MAH through...

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged...

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RESIDUAL SOLVENTS IMPURITIES. ICH Q3C

Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of...

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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...

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Brexit: Regulatory Impact

On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union,...

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Mutagenic impurities assessment following ICH M7 guideline

Mutagenic impurities assessment following ICH M7 guideline comprises impurities identification and classification, followed...

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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...

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Phases in the evaluation of the occupational exposure to a chemical...

After calculating the OEL and categorising the substance, the Occupational Exposure Band (OEB) must be obtained that will...

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Toxicological evaluation of impurities in pesticides

Use of pesticides is a key factor in control agricultural and food pests and to pest vector control, especially in epidemics....

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Pharmaceutical Market in EU

The Pharmaceutical Market in EU has a value of over 183 Million €, positioning Europe as the second biggest pharmaceutical...

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What is ICH Q3D on elemental impurities?

Directive ICH Q3D aims to limit the presence of potentially toxic elemental impurities (also known as heavy metals) in pharmaceutical...

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4 key points for a better understanding of ICH Q3D approach

Our experience with the implementation of ICH Q3D has showed that the new approach is not always well-understood by suppliers,...

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Addendum to the clinical overview

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

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Identification and quantification of impurities: a crucial aspect...

Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient...

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Azierta, Azierta Foundation and Paredox Therapeutics partner...

Cambridge, Massachusetts and Madrid, Spain – Paredox Therapeutics, LLC, Azierta Contract Scientific Support Consulting,...

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