We organised the Webinar “Clinical Data and Study Documents: operational aspects to support Inspection Readiness”, with the participation of:
- Sergio Scaccabarozzi, Scientific Director at Arithmos
- Jamie Marie Toth, Global Head Trial Master File Management & Records at BeiGene USA
- Giorgia Latteri, GxP Consultant & Auditor at Arithmos
The Webinar was full of insights. We are pleased to share the recording of the Webinar:
About the Webinar
The appropriate management of inspection readiness is important during the entire conduct of study development to avoid issues that might compromise the validity of the project and delay, or preclude, access to promising treatments by patients in need.
This webinar will explore:
• Compliance in Study Protocol and Study Procedures to generate good medical science.
• How to assure the Study Data compliance with GxP principles and accepted by regulatory authorities.
• TMF Management to be prepared for regulatory inspections
• How assure data-driven decisions serve ethical purpose and in the best interest for patients.
What will you learn during the Webinar?
The Webinar is designed to help you and your team prepare for regulatory inspections. Whether you’re in quality assurance, compliance, or operations, this webinar will provide practical strategies and insights, from experts in the USA and Europe to ensure you’re fully prepared for the inspection process.
Who is the Webinar for?
Life Science professionals in R&D, Clinical Operations, Quality Assurance, Medical Affairs, Patient Safety, Regulatory Affairs, IT, and Innovation roles.
Join us to gain expert tips and actionable guidance to ensure you’re always inspection-ready. Don’t miss this valuable opportunity to strengthen your compliance and audit preparedness!
Meet our Moderator
Sergio Scaccabarozzi
Scientific Director at Arithmos
With a medical degree and a specialisation in general surgery from the University of Milan, Sergio Scaccabarozzi has 35 years of experience in Clinical Research for global pharmaceutical and biotechnology companies.
In his professional life, Sergio spent 12 years as Head of Clinical Operations for the Italian affiliate of a big pharma and biotechnology company, managing a team of 90+ people and more than 220 studies from Phase I to Phase IV, RWE and providing support to institutions for Investigator initiated studies.
Sergio Scaccabarozzi enriched his professional experience by spending one year and a half as Operation Research Manager in one of the most important public research hospitals in Italy.
Sergio Scaccabarozzi is a member of scientific societies and working groups on Clinical Research, a recognized speaker at national and international events, with active editorial activities on Clinical Research and Life Science in general.
Meet our Speakers
Jamie Marie Toth
Global Head Trial Master File Management & Records at BeiGene USA, Inc
Jamie Toth is Global Head, Trial Master File Management & Records at BeiGene, home based in New Jersey, USA.
Jamie is a Steering Committee member for the CDISC TMF Reference Model Working Group. She is the Chair of the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). Jamie is also on the Board of Directors for the Association for GxP Excellence (AGxPE).
In addition, she has led many industry workstreams for TMF/eTMF including the clinical trials email guidance and the TMF Plan Template with industry colleagues and currently kicked off the CDISC ISF Reference Model initiative and is a member of the Standards Committee as part of CDISC.
Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University College of Medicine, holds a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
In her spare time, she enjoys family time – watching her youngest son play football and lacrosse, and boating, swimming, fishing and attending professional football games – her favorite team is the NY Giants!
Giorgia Latteri
GxP Consultant & Auditor at Arithmos
Experienced Quality Assurance professional, Giorgia is specialised in designing GxP compliant Quality Systems for pharmaceutical and biotechnology companies and hospitals.
Giorgia holds a Master’s Degree in Medical Biotechnologies from the University of Messina (Italy) and has experience in working both in preclinical and clinical areas.
Since 2021, Giorgia has worked in Arithmos as GxP Consultant and Auditor.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs.
