This valuable resource covers how inspections are going to be affected due to COVID-19 and includes information on:
What types of inspections are considered mission critical
How to add or change a facility in an application due to pandemic-related supply chain disruptions
What data is required to support a manufacturing process or facility change
How to file an application that includes facilities in regions affected by pandemic travel restrictions
The FDA’s response to applications including facilities that cannot be inspected due to travel restrictions
During this time of uncertainty, it is more important than ever that the pharmaceutical industry be able to continue research as well as manufacturing and distribution. ISPE is here to support our members, help them continue their quest for knowledge, and provide them with ways to stay connected. Our COVID-19 (Coronavirus) Pharma Industry Resources Page has a complete list of global and local resources available to you including articles, webinars and links to industry information.
We are constantly being influenced and we ourselves are influencers. As children, we hear the quote that “sticks and stones may break my bones, but words will never hurt me.” What people say and even what people do not say, can have a lasting impact. We are first influenced by our families and some...
2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...
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...