Investigator-initiated studies help address important clinical questions, often without the bias of industry sponsorship. As these trials grow in size and complexity, investigators must be able to anticipate and address supply chain management problems. Some challenges they might face are commercial drug procurement, budget reductions, as well as regulatory and time constraints. In this free webinar, the featured speakers will discuss these challenges in-depth and offer innovative solutions to ensure IIS run smoothly.
The session will provide you with an opportunity to:
- Understand best practices for addressing the potential challenges in ensuring IIS drug supply availability while balancing cost and risk
- Review of the current IIS landscape: the increase in scale and complexity of IIS programs
- Forecasting of drug supply requirements at an individual study or program level
- Optimising pack design for IIS
- Labelling strategies to support IIS
- Regulatory considerations
Speakers
Eoin Doyle, Supply Chain Manager, Almac Clinical Services
Eoin Doyle joined Almac Clinical Services in 2009 and has vast expertise in the area of global clinical supply chain management. As a supply chain manager, Eoin is responsible for all aspects of investigational medicinal product (IMP) supply for clinical trials including demand planning and forecasting, packaging, labelling, logistics and interactive response technology (IRT) set-up and maintenance. He has worked on several large investigator-initiated trial programs across multiple therapeutic areas. Eoin graduated with a Bachelor of Engineering degree from Dublin City University. He is based in Almac’s Craigavon office.
Message Presenter
Martin McGlone, Project Services Manager, Supply Chain Management, Almac Group
Martin graduated from Ulster University with a Bachelor of Science in Biological Sciences and Master of Science in Biomedical Sciences. He joined Almac in 2005 and since then has held a number of roles within project management and supply chain management.
Martin has expert knowledge in the set-up of investigator-initiated studies, from individual studies to large programs of over 100 studies. He has seen at first hand the challenges these studies can present and has extensive experience in developing effective, robust and innovate solutions. Since 2009 he has played a key role in the expansion of Almac’s supply chain management (SCM) service and is currently responsible for the delivery of the SCM service in the EU and APAC.
Message PresenterWho Should Attend?
- Clinical Supply Chain Management
- Inventory Management
- Label Development and Regulatory Vetting
- Clinical Trial Design
- Clinical Operations
- Clinical Research
- Local and Global Distribution
- Project Management
- Logistics
What You Will Learn
In this webinar, attendees will learn about:
- Best practices for addressing the potential challenges in ensuring IIS drug supply availability while balancing cost and risk
- IIS program trends: increases in scale and complexity
- Drug supply forecasting at an individual study or program level
- Packaging design optimisation
- Labelling strategies to support IIS
- Regulatory considerations
Xtalks Partner
Almac Group
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organization that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia. Click here to view our facilities. We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. We will be exceptional, always.
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