Monthly Archives: September 2015

Sep 2015

GCP Change – New Risks for Biotech?

By |2020-09-23T09:47:02+02:00September 21, 2015|News|0 Comments

 Going Public Biotechnology Magazine p.76-77 The new upcoming GCP E6(R2) addendum reforms clinical monitoring and clinical trial management. Risk factors are an important component. What this means for a biotech company: clinical trial risks are easy to foresee, site level risks and operational risks [...]

Sep 2015

ICH GCP Addendum Mind Map

By |2019-03-12T12:30:06+02:00September 10, 2015|Blog, Free Infographics|1 Comment

The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP.   Let [...]

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