Data Integrity and Analytical Instrumentation - Current Status
Join Sergey Arzhantsev, Ph.D., a research physicist working for CDER at the FDA, and Adrian Davis, PhD., the Data Integrity lead at Pfizer’s Pharmaceutical Sciences organisation, for a thought-provoking webinar on the subject of Data Integrity (DI). The goal of the webinar is to hold a high-level scientific discussion on the importance of DI within the pharmaceutical industry with views from the speakers on the overall trends relating to DI, for example:
- What is the overall scope for DI in Pharma/Biopharma, and how does the speaker think that the scope is evolving?
- Are there any major recent findings about the state of DI: are there any trends or emerging themes?
- During product development, at what stage should DI become a significant focus of efforts; has that changed over the past few years?
Speakers
Sergey Arzhantsev, Ph.D
Research Physicist at FDA
Sergey Arzhantsev is Research Physicist in the Office of Testing and Research at the Food and Drug Administration in St. Louis, MO. He joined the Food and Drug Administration in 2009 and maintains an active research program in state-of-the-art technologies for drug analysis to support quality assessments. He received Ph.D. in Physics from M. V. Lomonosov Moscow State University in Moscow, Russia. He subsequently performed research at the Institute for Molecular Science, Japan and the Pennsylvania State University. In his present position at the FDA, Dr. Arzhantsev utilizes spectroscopic methods to study the quality and stability of pharmaceutical and biotechnology products.
Adrian Davis, Ph.D
Data Integrity Lead; Pfizer
Adrian Davis is a team leader and Research Fellow in Analytical R&D at Pfizer’s research laboratories in Sandwich, UK. He has over 25 yrs. of R&D experience, and in recent years has led Data integrity activities for Pfizer’s Pharmaceutical Sciences organization, focusing on the laboratory operations supporting clinical manufacturing activities. He’s also part of a strategic leadership group that is implementing Digital Transformation within the R&D environment and is very interested in technologies that help to simplify a very diverse laboratory data landscape. Fun fact: Adrian’s first professional lecture was at a Bruker NMR user meeting in the early 1990s, and he still remembers being so nervous that he couldn’t eat any of the lavish lunch that was provided!