The ISPE Drug Shortages Initiative focuses on the technical, scientific, manufacturing, quality and compliance issues associated with a company's supply chain and related to its ability to source, manufacture and distribute products that have resulted in drug shortages. For example:
- Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making a product.
- Product quality issues that result in temporary or permanent halting of production.
- Lack of secure, consistent availability of active ingredients, components, containers, or closures of suitable quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization of the supply chain for ingredients and manufacturing.
- Shifts in demand that arise from shortages of another drug - causing a chain reaction of shortages.
- Unexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market demands.
This Introductory Webinar will review:
- Drug Shortages around the world - do we have a problem?
- The ISPE Drug Shortages Initiative: How did it start and what has it achieved.
- Review of the ISPE Drug Shortages Survey results and identifying root causes.
- Understanding the ISPE Drug Shortages Prevention Plan and the six dimensions.
- Practical tools for your use in preventing shortages.
- Summary and next steps.
Attendance Recommended For:
- Anyone involved in the operation of the pharmaceutical supply chain for both investigational and commercial products.
John Berridge retired from Pfizer Global Research & Development at Sandwich in January 2006 as Vice President of Pharmaceutical Sciences. He spent more than 31 years at Pfizer, starting as an Analytical Chemist, and ultimately responsible for all aspects of the product realization disciplines of chemistry, pharmacy, analytical and regulatory CMC in Europe. His research interests have been directed towards high performance liquid chromatography, with special emphasis on the use of chemometrics. This research was recognized by the award of the Chromatographic Society’s Jubilee medal in 1989. John was involved in the ICH processes from their inception until November 2007, representing EFPIA in the Quality topics discussions. He has contributed to guidelines on stability, on impurities in drug substances and their dosage forms, and on specifications. He was the Rapporteur to Step 2 for the Common Technical Document (Quality) and for the pharmaceutical development guidelines (Q8 and Q8(R1)). He has also acted as a facilitator in the development of the ACE and A-Mab case studies supporting the implementation of Quality by Design. In 1995 he was presented with an FIP IPS award for his outstanding contribution to industrial pharmacy and in 1997 he was awarded the Royal Pharmaceutical Society Chiroscience award for his services to the pharmaceutical industry. In 2013 he received the ISPE Joseph X Phillips award also for his services to the industry. John now acts as an independent consultant and as an Advisor to ISPE and he has been a major contributor to all the phases of the ISPE drug shortages initiatives. He is currently the moderator of the European Inter-Association drug shortages task force, an industry group formed to respond to the European Medicines Agency request for action to address shortages.