Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain aspects of the Medical Device Regulation apply to the device component of the product.
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
What is Pharma 4.0? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centric perspective.
The 2020 ISPE Member Meeting included most of the usual components of live Member Meetings: Outgoing ISPE International Board of Directors Chair Frances Zipp passed the gavel to incoming Chair Joanne Barrick, new Board members began their terms, Board members completing their terms departed, and ISPE members received a report on the state of the Society’s business.
The COVID-19 pandemic has brought increased harmonization and interaction among regulators around the world and the opportunity to consider changes implemented during the pandemic for the long term. Six regulators from five regulatory agencies discussed these issues at the “Global Regulatory Town Hall–The Impact of a Pandemic on Harmonization and...
