BioPharm International-10-01-2018

BioPharm International

AAPS Traces the Path to ICH M10

October 01, 2018

Guest Editorial

31

10

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

The Link Between Data Integrity and Quality Culture

October 01, 2018

Ask the Expert

31

10

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

BioPharm International, October 2018 Issue (PDF)

October 01, 2018

Issue PDF

31

10

Click the title above to open the BioPharm International October 2018 issue in an interactive PDF format.

FDA Clarifies Worldwide Inspection Policies

September 12, 2018

Regulatory Beat

31

10

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.