Live Webinar Date: 30th of September 2024
Time: 3:30 PM – 4.30 PM CEST + Q&A Session
Language: English
About the Webinar
The importance of Quality Assurance (QA) in clinical research is reflected in:
• the need for compliance with the protocol and study procedures to generate good medical science.
• Compliance with regulations, GCP and GXP in general, to assure that the study data are accepted by regulatory authorities.
• Making sure the decisions taken based on data are in the best interest of patients. This means giving a social and ethical purpose to clinical research.
For these reasons, 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 of promising treatments by patients in need.
What will you learn during the Webinar?
The webinar will provide you with useful insight into how QA is important for data and documents that drive a decision to approval, commercialisation, and prescription of medications.
And, most importantly, how to be ready to manage inspections.
Who is the Webinar for?
People working in the Pharma industry in R&D, Clinical Operations, Medical Affairs, Patient Safety, regulatory, IT, and Innovation.
People from institutions, regulatory authorities, and scientific societies could have useful insight to be better prepared for the future to come.
Q&A Session
Sign up and leave your question in the dedicated registration form. Our experts will answer you during the Q&A session, at the end of the webinar.
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.
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.
