Important Considerations When Initiating a Clinical Study
Planning and execution of the development of a new drug, and ultimately releasing it to market, can be extremely complex and includes many challenges.
It is essential that a sponsor company works closely with their suppliers to develop and implement a streamlined and efficient process to ensure successful execution and delivery of their clinical trial. Having a strong project management team in place, who have the experience and expertise to support your project, is vital to a smooth and successful outcome resulting in initiation of a clinical trial.
This webinar will look to identify potential risks and/or pitfalls which may be encountered during packaging and labeling, but can be planned for up front. PCI Clinical Services will also share specific processes, hints and tips which will make your projects run smoothly and help to mitigate any unexpected developments.
Lucy Smith, Senior Project Manager, PCI Clinical Services
Lucy Smith is Senior Project Manager at PCI Pharma Services. Since graduating from Cardiff University in 2013 with a BSc in Psychology, Lucy has worked entirely within the clinical packaging space. Her vast experience has been gained working with a number of CMOs across a wide range of roles. Lucy has worked within the PCI Clinical Services Project Management team for 3 years managing a number of key accounts for clients globally, specializing in the management of the packing and release of clinical trial products for European study sites.
Rita Wareham, Project Manager, PCI Clinical Services
Rita Wareham is a Project Manager at PCI Pharma Services, working specifically in support of PCI Clinical Services clients. Rita began her career as a Pharmacy Technician and worked in both hospital and retail pharmacies. After several years working in a hospital pharmacy as a Senior Pharmacy Technician in aseptic manufacture, Rita transferred her skills into industry, joining AstraZeneca in 1989 (formerly Fisons/Astra) as a Clinical Trials Supply Chain Manager. This role saw her responsible for leading cross-functional study delivery teams for a portfolio of global clinical studies across all phases of the drug development process. After 22 years, with the closure of the AstraZeneca Loughborough site, Rita joined PCI Clinical Services as a Clinical Project Manager where she manages a number of key accounts for clients globally, overseeing and delivering the packing and release of clinical products for studies around the world.
Joe Monteiro, Regional Sales Manager, Essentra
Joe Monteiro has 22 years’ experience in International Business Development and Project Management within the Clinical Trial Packaging Sector. He is currently working for Essentra in the Technical and Business Development Team overseeing Clinical Trial Packaging.
Who should attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device manufacturers involved in:
- Clinical supply chain / distribution / procurement
- Clinical packaging / labeling
- Clinical operations
- Quality assurance
- Regulatory affairs
What You Will Learn
In this webinar, the participant will:
- Understand the benefits of working with an experienced Clinical Trial Packing Project Manager
- Learn the tips and tools which will assist in delivering an efficient project
- Have the opportunity to ask the clinical packaging experts questions you need answers to