Latest Insights

RA & PhV

EudraVigilance Data Analysis System (EVDAS) in the Signal Management Process: Are You Really Ready?

Discover the power and efficiency of EudraVigilance Data Analysis System (EVDAS) in signal detection for pharmacovigilance. Explore its key features.

RA & PhV

Elemental Impurities for Safe Veterinary Medicinal Products, one year after the due date

Discover the ongoing challenges faced by Veterinary Marketing Authorization Holders and Manufacturers in managing elemental impurities in veterinary.

RA & PhV

What is SPOR?

Learn about SPOR (Substance, Product, Organization and Referential), the European Medicines Agency's requirement for implementing ISO IDMP standards..

RA & PhV

Are your Veterinary Medicinal product information already compliant with QRD Version 9.0? Be prepared to submit the variations

The EMA has introduced the QRD Template Version 9.0 for product information used by the MAH. The updated template must be adopted by January 2027.

RA & PhV

Environmental Risk Assessment of Medical Products for Human Use: Comparison between EMA & FDA Requests

The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.

RA & PhV

Is your internal personnel and sales force adequately trained? And your pharmacovigilance staff?

Trained personnel play a vital role in ensuring medicinal safety in the animal health business. To achieve this, companies must focus on two primary.

RA & PhV

Is your Quality Management System effective in supporting the pharmacovigilance processes and activities? Are you ready for your next inspection?

Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.

RA & PhV

Prevention and management of human medicinal product shortages in compliance with the recent EMA guideline on good practices for industry

2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.

RA & PhV

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.

RA & PhV

Is your Pharmacovigilance Systems Master File already approved and in place?

Pharmacovigilance System Master File (PSMF), describes the details of the pharmacovigilance system, focusing on the Quality Management System (QMS).