The quality, safety and efficacy of medicinal products depend on a whole range of different factors. Drug theft is an increasing issue here. Please read more here
Second part of the Pharma Congress 2019 conference report: what has changed in the areas of data integrity, modern qualification, etc.? Please read more here
Outsourcing is a critical process in the pharmaceutical industry. A whole series of quality assurance requirements are laid down in the corresponding GMP regulations. Please read more here
An increase in data integrity and data governance observations during inspections made the development of new guidances on the subject neccessary. Please read more here
The Round table discussion brought together representatives from authorities, industry and academia to exchange experiences on the GMP guidelines specific to Advanced Therapy Medicinal Products. Please read more here
First part of the Pharma Congress 2019 conference report: what has changed in the areas of continuous manufacturing, digitalisation, process optimisation, etc.? Please read more here
The second ECA conference on GMP for Advanced Therapy Medicinal Products discussed important ATMP topics with speakers from authorities and the industry. Please read more here