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.
The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.
Focus on the important updates of the publishes Guideline on Computerized Systems and Electronic Data for Clinical Trials.
MHRA's top findings per chapter and E-book for download
Pharmacovigilance System Master File (PSMF), describes the details of the pharmacovigilance system, focusing on the Quality Management System (QMS).
FemTech Next: What are ATMPs, How they are applied for FemTech Health, and how they can target Genetic Disorders Diseases.
Can a treatment with cannabinoids be personalized?
How artificial intelligence can help with GxP compliance, and why companies should consider validating AI/ML GxP systems.
What is Shipping validation under the GOOD DISTRIBUTION PRACTICE, and what is the importance of the cold chain in the pharmaceutical market.
The importance of Data Governance and Data Integrity, in maintaining paper and electronic records at the Quality Control Laboratory.
