Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.
The bio/pharma industry has demonstrated its R&D capabilities by accelerating development of vaccines and therapeutics to combat COVID-19. At the same time the industry faced intense scrutiny and political pressure. What are the short-, medium-, and long-term implications for bio/pharma development and manufacturing?
Panelists James Mayne, PhD, vice-president, Science & Regulatory Advocacy, PhRMA and Phyllis Arthur, vice-president for infectious diseases and diagnostics policy, Biotechnology Innovation Organization (BIO) shared insights during this Editors’ Series discussion moderated by editors of Pharmaceutical Technology and BioPharm International. The discussion was recorded on Nov. 11, 2020, during the 2020 Bio/Pharma Virtual Congress.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.