Ms. Miceli will focus on the importance of qualifying comparator suppliers and working with a GMP facility to ensure successful clinical trial supplies. She will address how delays to a site and poor quality product can negatively impact a clinical study, as well as give insight regarding how proactive approaches to compliance can help minimize risk, benefit the patient and maximize the success of the study. Lastly, Ms. Miceli will discuss regulatory compliance and provide suggestions to give regulatory teams confidence in their product.
Josette Miceli is the Director of Quality for Clinical Supply Services at Catalent Pharma Solutions, and has played a major role in implementing robust processes, quality systems, and has helped to ensure the compliance of Catalent's Philadelphia site. Ms. Miceli joined Catalent over five years ago from Aptuit where she was previously a Quality Manager, and prior to that, she supported the R&D of HIV therapeutics and analytical method development and validation at Progenics Pharmaceuticals. She is a member of the American Society of Quality's Quality Management Division Leadership Team, and acts as the Member Data Analyst. She obtained her Bachelors Degree in Biological Sciences from Rutgers University and her Masters Degree, also in Biological Sciences, from St. Joseph's College.
To arrange a follow-up interview with Ms. Miceli, please contact Patricia McGee.
For more information or to register for the conference, visit here.
To learn more about Catalent's expertise in global comparator sourcing, click here.
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