PQRI Risk-Management Case Studies: HACCP Training Tool Guidance

The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.