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RA & PhV

New ICH Q2 (R2) and ICH Q14: a Step Forward Towards the Validation of Analytical Methods

New ICH Q2 (R2) and ICH Q14 set to revolutionize analytical method validation in the pharmaceutical industry, enhancing quality, safety, and.

RA & PhV

QV Hub: PQE Pharmacovigilance System for Veterinary MAHs

Discover how PQE Group's QV Hub system revolutionizes pharmacovigilance for veterinary MAHs

RA & PhV

Empower Pharmaceutical Company Compliance through Expert Pharmacovigilance

Empower pharmaceutical companies with expert pharmacovigilance services from PQE Group. Stay compliant with regulations, ensure drug safety.

RA & PhV

Clinical and Pre-clinical trials for Veterinary Medicinal Products

Learn about the importance of clinical and pre-clinical trials for veterinary medicinal products, including regulatory requirements, study types, and.

RA & PhV

The Impact of Digitalization in Pharmaceutical Regulatory Affairs

From streamlining processes to enhancing data analytics, learn how embracing digital technologies revolutionizes industry operations.

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.