The day-to-day practice of clinical supply management (CSM) faces many challenges. Clinical trials have multiple moving parts that must be proactively managed, including clinical supplies that need to be prepared well in advance of the actual study start.Supply delays, stock-outs or excess inventory are all undesirable and potentially risky scenarios. In recent years, clinical studies have become more global and increasingly complex, involving a multitude of clinical sites and network depots spanning multiple countries and geographic regions, each with a unique set of challenges and requirements. When more countries and regions are added or dropped during a study, CSM activities such as forecasting becomeimportant as they can plan for and guide an appropriate response to such challenges.
In addition to the above, many APAC-based sponsors are planning to conduct trials in the European Union (EU). The role of the EU Qualified Person (QP),difference between the EU and the UK, and QP processes can seem complex and challenging, but are essential to understand if studies are to be successfully conducted in this important region.
View this webinar to learn how experienced clinical supply chain managers can help sponsors develop more robust and proactive clinical supply plans, understand the critical role of the Qualified Person in EU clinical trials, and explore more customized solutions to clinical supply challenges for APAC customers.
Senior Batch Processing Manager, Qualified Person,
Education and work experience as Qualified Person
Leading the Catalent Germany Team, responsible for batch certification and releasing procedures.
Catalent Pharma Solutions
Senior Clinical Supplies Manager, Asia Pacific Region
Catalent Pharma Solutions
Catalent is a global leader in clinical supply services, with comprehensive and flexible solutions for small molecules, biologics, and cell and gene therapies,including integrated solutions to accelerate speed to clinic. Catalent offers a full range of services including clinical supply management, comprehensive packaging solutions, comparator sourcing, cold chain storage and global distribution, and specialized supply chain services including direct-to-patient and demand-led supply. With nine GMP clinical packaging facilities and over 50 strategically located depots on six continents, combined with more than 25 years of experience across thousands of studies in more than 80 countries, Catalent has the comprehensive services, global scale, and expertise necessary to reliably supply clinical trials of all sizes and complexities anywhere in the world.
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