Register for this webinar to hear about a real case study and explore challenges and best practices when it comes to comparator sourcing, blinding/over-encapsulation and analytical services for your oral solid dose clinical trial.
Join our speakers Rachel, Yash and Dan when they share their expertise, talk about risk and pitfalls, provide solutions, discuss regulatory affairs between US, UK and the EU and look into strategies to successfully setup your clinical trial for oral solid dose drugs.
Areas covered by the webinar include:
- Comparator sourcing strategies and comparing different approaches from an economic and risk perspective
- Challenges and solutions when over-encapsulation is required
- How to manage component and composition changes
- Stability data –expiry and beyond
- Interdependencies between the different areas
The webinar will provide a holistic view of the entire process and link the different areas to make your next project a success.
Rachel Curran, Head of Sourcing Services, Sharp
Rachel Curran, currently working as Head of Sources Services and Special Accounts for Sharp Clinical Services. Rachel has been working in the industry for over 25 years. Rachel’s area of expertise is in assisting clients with solutions for their sourcing and packaging challenges, understanding the complexities of budgets, compliance packaging and patient recruitment to minimises exposure to risks.
Daniel Zuccarello, Director Analytical Services, Sharp
Dan Zuccarello currently serves as the Director of Analytical and Research Services for Sharp Clinical Services in Bethlehem PA. He has over 40 years of industrial experience in both food and pharmaceutical AR&D and has been with Sharp Clinical Services for 7 ½ years. Dan is responsible for both the Analytical and Research & Development Groups providing R&D/formulation support, release and stability testing and production support as well as serving as a technical SME for new business opportunities. Dan has published and presented several papers on robotics, instrument calibration, novel drug delivery systems and drug release patterns, USP elemental impurities and elemental impurities as part of extractables and leachables. He holds a B.A. degree from the University of Delaware and an M.B.A from Rutgers Graduate School of Business – Camden New Jersey.
Yash Patel, Scientist, Formulation Development, Sharp
Yash Patel currently works for Sharp Clinical services as Formulation Scientist in research and development. Yash has been working in industry for almost 10 years handling bench-top formulation batches to scale up manufacturing. His areas of expertise are novel drug delivery technology, complex formulation, and designing and troubleshooting process related issues. Yash holds a Master’s degree in Industrial Pharmacy and currently pursuing Ph.D. in Pharmaceutics from Long Island University, New York.
Who Should Attend?
- Clinical Trial Supply Project Managers
- Study Managers
- Clinical Trial Director
- Sourcing Managers
- Clinical Trial Project Manager
- Program Manager
- Personnel working on setting up an oral solid dose clinical trial
What You Will Learn
In this webinar, we will address many of the common questions relating to the clinical supply of your solid oral dose:
Comparator sourcing strategies
- Assessing most relevant strategies for your trial
- Common pitfalls to avoid
- What you need to consider
- Technical solutions, requirements and challenges
- Thinking about the patient
- Managing expiry dates for your trial – strategies for extending expirations
- Dissolution profiling
- How do regulatory requirements differ in the EU to US?
Sharp Clinical Services
As a division of UDG plc., a global healthcare services company with a market cap of over €1 billion, Sharp Clinical Services is committed to helping our customers achieve clinical trial success. Our customized and tailored approach to your program is what makes Sharp different than the other clinical trial manufacturers and packagers in the industry. Our global project management process links our sites in Phoenixville, PA and Crickhowell, UK and is focused on a tailored and flexible approach to your clinical trial through dedicated project management. At Sharp we are committed to serving our customers with the highest levels of excellence with on time delivery rates of 99.9% and a global depot network of over 30 depots in every major region of the world. Our Clinical services include:
- Analytical & Research
- Formulation Development
- In House Label Design & Printing
- Clinical Manufacturing
- Packaging & Labeling
- Storage & Distribution
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