Audio Presentation of ICH Q8, Q9 and Q10 now available

Recordings of some presentations have been made during a meeting of the International Conference on Harmonisation. These have now been posted online.

The ICH Guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality System have real influence on the implementation of GMP. Because these Guidelines are in equal measure legally binding in Europe, the USA and Japan, an ICH working group has published recommendations for the implementation. Moreover, several workshops have been carried out. Initially, only the presentation documents had been made available, but now audio presentations are available too. You can thus listen to the presentations and simultaneously read the slides on your computer.

Case Studies

Product Development 

Regulatory Assessment

Manufacturing Implementation and PQS Considerations

Inspections

Recommendation: The European Compliance Academy is organising an ICH Q9 und Q10 Training Course. Top-class speakers Richard Dick Bonner (formerly Eli Lilly), Dr Bernd Renger (QP Association), Dr Thomas Schneppe (BayerSchering), Dr Heinrich Prinz (Cellmed) and Dr Helene Zuurmond (Pfizer)  will be leading the programme with workshops.