Latest Insights

Clinical Research

EMA Publishes Guideline on Computerized Systems and Electronic Data in Clinical Trials

Focus on the important updates of the publishes Guideline on Computerized Systems and Electronic Data for Clinical Trials.

GxP Compliance

MHRA Top 10 Inspection Findings

MHRA's top findings per chapter and E-book for download

Pharmacovigilance

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).

FemTech

Advanced therapies meeting FemTech: Focus on the prenatal and perinatal diseases

FemTech Next: What are ATMPs, How they are applied for FemTech Health, and how they can target Genetic Disorders Diseases.

Medical Cannabis

Italian Phytovigilance adverse reactions database’s evaluation

Can a treatment with cannabinoids be personalized?

GxP Compliance

Artificial Intelligence Learning algorithms validation in the context of GxP

How artificial intelligence can help with GxP compliance, and why companies should consider validating AI/ML GxP systems.

GxP Compliance

Shipping Validation and the Importance of the Cold Chain in the Pharmaceutical Market

What is Shipping validation under the GOOD DISTRIBUTION PRACTICE, and what is the importance of the cold chain in the pharmaceutical market.

CSV & Data Integrity

Data Integrity and Data Governance in the Quality Control Laboratory

The importance of Data Governance and Data Integrity, in maintaining paper and electronic records at the Quality Control Laboratory.

Audits

The auditor’s approach in the world: GMP and culture

Deep dive into the approach and the culture of an auditor, as per the Guidelines for auditing management systems.

Commissioning, Qualification and Validation (CQV)

Commissioning and Qualification of Laboratory Instruments

What is the purpose of the document about Commissioning and Qualification of a laboratory instruments, and how it can be implemented?