The 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offers a new and exciting format where participants will be able to interact directly with pharmaceutical industry and regulatory leaders in a four-series workshop rotation. Today’s blog focuses on the details of Linking Quality to Clinical Relevance, one of the four core workshops taking place at the conference. Regulatory officials and the pharmaceutical industry have been exploring how clinically relevant specifications (CRS) might be of value with regards to patient safety. Varying positions on these topics have been proposed:
Questions remain on the extent of clinically relevant specifications boundaries including:
The Linking Quality to Clinical Relevance workshop at the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offer attendees the opportunity to discuss experiences and identify solutions to address the challenges of implementing the use of clinically relevant specifications.
Tired of listening to talk after talk? Learn why the 2017 IPSE/FDA/PQRI Quality Manufacturing Conference will be unlike any pharmaceutical industry conference you've experienced before! 2017 ISPE/FDA/PQRI Quality Manufacturing Conference The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.
Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...
The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local...
The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.