Latest Insights

Regulatory Affairs

European Medicines Agency Guidelines for the Environmental Risk Assessment of Veterinary Medicinal Products (VMPs)

The European Medicines Agency (EMA) has issued guidelines for the environmental risk/impact assessment (ERA or EIA) of veterinary medicinal products.

Medical Cannabis

Legislative panorama: Focus on Portugal

What is the current legislative situation in Portugal related to Medical Cannabis

Pharmacovigilance

Why Pharmacovigilance is Important for the Veterinary Surgeon and Industries?

Pharmacovigilance system for the Veterinary Industries and that the compliance to the requirements requested by the EU regulations.

CSV & Data Integrity

ALCOA++: What’s New, What’s Important, and  What You Need to Know

What does the acronym Alcoa++ stand for?

Medical Cannabis

Genetic screening, personalized therapy and the importance of biomarkers in medical cannabis treatment

Can a treatment with cannabinoids be personalized?

GxP Compliance

Entering the EU Market of generics: products’ registration, do’s and don’ts

How to register a generic medicine in the European market?

CSV & Data Integrity

How to Validate a Chromatographic Data System (CDS)

Understand the importance of Computerized System Validation and how it differs from Factory Acceptance Testing.

Audits

GDP Audits

Learn about Good Distribution Practice (GDP) guidelines by EMA, and how GDP audits ensure quality and integrity of medicinal products throughout the.

Cybersecurity

Go beyond data integrity; Information chain management part two

Learn about the importance of contemporaneous, original, and accurate information, often overlooked in information systems.

Commissioning & Qualification

FAT and SAT: What is the difference and why are they so important?

Do you know FAT and SAT? Learn their differences, and why they are essential for demonstrating equipment quality, compliance, and performance.