How to prepare a PBRER for medicinal products without critical issues PharmacovigilanceNews

How to prepare a PBRER for medicinal products without critical issues

A PBRER is not simply a periodic collection of case reports, signals, and literature findings.…

EleonoraHaySeptember 2, 2026

Regulatory Affairs: maintaining control throughout the product lifecycle News

Regulatory Affairs: maintaining control throughout the product lifecycle

An incomplete dossier, a variation submitted too late, or a claim that is not fully…

EleonoraHaySeptember 2, 2026

How to work in pharmaceutical Quality Assurance Quality AssuranceNews

How to work in pharmaceutical Quality Assurance

Quality Assurance (QA) is one of the most sought-after career paths within the pharmaceutical industry.…

EleonoraHayAugust 31, 2026

Literature searches in scientific databases Medical InformationNews

Literature searches in scientific databases

A Medical Information request about a potential safety signal, the preparation of a clinical dossier,…

EleonoraHayAugust 31, 2026

Case reports and ICSRs: what they are and why they matter in pharmacovigilance PharmacovigilanceNews

Case reports and ICSRs: what they are and why they matter in pharmacovigilance

Pharmacovigilance relies on the collection and analysis of safety information generated during real-world use of…

EleonoraHayAugust 5, 2026

Pharmacovigilance outsourcing for pharmaceutical companies PharmacovigilanceMedical InformationNews

Pharmacovigilance outsourcing for pharmaceutical companies

A report of a suspected adverse reaction is never just a piece of data to…

EleonoraHayAugust 3, 2026

Soft skills required in pharmaceutical Medical Information Medical InformationNews

Soft skills required in pharmaceutical Medical Information

Managing scientific information about medicinal products requires strong technical expertise, a solid understanding of the…

EleonoraHayJuly 31, 2026

Quality Assurance in pharmaceutical companies: roles and required skills Quality AssuranceNews

Quality Assurance in pharmaceutical companies: roles and required skills

Ensuring quality in the pharmaceutical industry means making sure that processes, systems, and activities are…

EleonoraHayJuly 29, 2026

Signal Detection in Pharmacovigilance: identifying signals before they become risks PharmacovigilanceNews

Signal Detection in Pharmacovigilance: identifying signals before they become risks

The safety of a medicinal product depends not only on the collection of reports of…

EleonoraHayJuly 27, 2026

Medical Information and the quality of scientific responses: standards and procedures Medical InformationNews

Medical Information and the quality of scientific responses: standards and procedures

In Medical Information, the quality of scientific responses depends on the ability to transform evidence,…

EleonoraHayJuly 24, 2026

Pharmacovigilance and vaccines: how adverse events are monitored PharmacovigilanceNews

Pharmacovigilance and vaccines: how adverse events are monitored

In the field of pharmacovigilance, vaccines represent an area where safety monitoring plays a particularly…

EleonoraHayJuly 22, 2026

Pharmaceutical Risk Management: preventing errors and operational issues Quality AssuranceNews

Pharmaceutical Risk Management: preventing errors and operational issues

In the pharmaceutical industry, preventing errors and operational issues is essential to protect product quality,…

EleonoraHayJuly 21, 2026

How to properly manage off-label requests in Medical Information Medical InformationNews

How to properly manage off-label requests in Medical Information

Managing off-label requests is one of the most sensitive areas within the Medical Information function,…

EleonoraHayJuly 17, 2026

EudraVigilance database: what it is and how it is used PharmacovigilanceNews

EudraVigilance database: what it is and how it is used

Within the European pharmacovigilance system, EudraVigilance serves as the central IT platform for collecting, managing,…

EleonoraHayJuly 15, 2026

Change control in pharma: managing changes effectively across processes Quality AssuranceNews

Change control in pharma: managing changes effectively across processes

Change is a constant in the pharmaceutical industry. The introduction of new technologies, upgrades to…

EleonoraHayJuly 13, 2026

GxP documentation: why SOPs and procedures must always be kept up to date Quality AssuranceNews

GxP documentation: why SOPs and procedures must always be kept up to date

GxP documentation is one of the foundations of quality, regulatory compliance, and patient safety in…

EleonoraHayJuly 10, 2026

Medical Information and regulatory compliance in the pharmaceutical industry Medical InformationNews

Medical Information and regulatory compliance in the pharmaceutical industry

In the pharmaceutical industry, regulatory compliance refers to adherence to a structured set of requirements…

EleonoraHayJuly 8, 2026

Qualified Person for Pharmacovigilance (QPPV): who they are and what they do PharmacovigilanceNews

Qualified Person for Pharmacovigilance (QPPV): who they are and what they do

Within the European pharmacovigilance system, the Qualified Person for Pharmacovigilance (QPPV) holds formal responsibility for…

EleonoraHayJuly 7, 2026

Data Integrity in Pharma: ensuring data reliability and security Quality AssuranceNews

Data Integrity in Pharma: ensuring data reliability and security

Every critical decision in the pharmaceutical industry relies on data. For this reason, data integrity…

EleonoraHayJuly 7, 2026

Medical Information and Medical Affairs: functions, differences, and collaboration Medical InformationNews

Medical Information and Medical Affairs: functions, differences, and collaboration

Medical Information and Medical Affairs play a central role in the management of scientific information…

EleonoraHayJuly 7, 2026