The debate on the “Do No Significant Harm” principle in R&D
by Giulianna Miglierini The “Do No Significant Harm” (DNSH) principle is a widely diffused approach aimed to guarantee…
Comments to the draft ICH guidelines Q2(R2) and ICH Q14
by Giuliana Miglierini The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical…
Webinar: Implications and Opportunities of ICHQ2(R2) and ICHQ14
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 15th…
Steps towards the final approval of the IP action plan
By Giuliana Miglierini The end of 2021 may see the final approval of many pieces of the new…
Draft guidelines, open for consultation
ICH guideline Q13 on continuous manufacturing of drug substances and drug products This guideline describes scientific and regulatory…