Category: EMA

How To Apply QbD to Drug Device Combination Products

Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...

Influenza vaccines – Quality module

Recently, EMA (European Medical Agency) published a Guideline on Influenza Vaccines – Quality Module. Though the main focus of this EMA guideline was not QbD or PAT, one section – 4.1.1.6. Characterisation – was relevant to QTPP, CQA, CPP and hints on the details of the design space (albeit...