ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
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...
2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and gene therapies. There are lessons to learn from the industry adaptation during these months,...
Twenty-four hours of sessions, mentor circles, book clubs and more with ISPE Women in Pharma® (WIP) took place on 27–28 October. The event had almost 160 registrations for the virtual event, which brought together ISPE members around the world for interactive opportunities to learn and exchange ideas.
Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
GlaxoSmithKline is the 2020 Facility of the Year Award Winner for Social Impact for their Attachment Inhibitor (AI) Project in Parma, Italy.
United Therapeutics is the 2020 Facility of the Year Award Winner for Social Impact for their Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory in Silver Spring,...
Bristol-Myers Squibb is the 2020 Facility of the Year Award Winner for Project Execution for their Multi-Purpose Cell Culture...
Janssen Pharmaceuticals is the 2020 Facility of the Year Award Winner for Process Innovation for their Mirror 1: A Continuous Manufacturing Platform in Beerse, Belgium.
Eli Lilly and Company is the 2020 FOYA Category Winner for Operational Excellence for their Lilly Innovation Development Center in Indianapolis, Indiana.
Sanofi is the 2020 Facility of the Year Award Winner for Facility of the Future for their Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham,...
Pfizer, Inc. is the 2020 Facility of the Year Award Winner for Facility Integration for their Andover Clinical Manufacturing Facility (ACMF) in Andover, Massachusetts.
