Quality & Safety Management in Drug Development
Pharmacovigilance is the important process of testing and analysis in the development of safe and effective medicines. While the development of innovative technologies can process huge amounts of data & analytics to monitor risks using real-world evidence on patients across the globe, adverse drug reactions (ADRs) remain a major cause of death in the US, and quality issues are impacting our drug supply. In 2019, 62% of the drugs in shortage were associated with quality concerns, leaving patients without access to medicines.
Hear from experts working in the field of quality assurance, drug safety and quality in this two-part series exploring aspects of Pharmacovigilance.
Episode 1: Excipients
David R. Schoneker, Vice Chair for Science and Regulatory Policy, International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)
Episode 2: Pharmacovigilance
Jan Petracek, Director, Institute of Pharmacovigilance