One of the key features of this newsletter is that it doesn’t assign anything that is just busy work. The Information is designed to capture the essential points, with an emphasis on those that directly relate to the individuals of the pharmaceutical Industry and helpful in sharpening the knowledge with current updates.
ICH’s Approach to Harmonize Generic Drug Standards
ICH is the global body to harmonize requirements. For Generic drugs, ICH’s approach will be crucial to standardize all requirements.
Bioequivalence studies in Humans
This is prime requirement in world of generic medicines.
WHY Third Party Auditing-Monitoring in Clinical Research?
This is need of an hour. Third eye is always useful while working in the regulated environment.
Root Cause Analysis of the Data Integrity Issues
This is the challenge industry is facing currently.