1990, April – ICH was first formed during a meeting, held by the EFPIA in Brussels, in 1990. Representatives of the regulatory agencies and industry associations of Europe, Japan, and the United States met, primarily, to plan an International Conference.
1991– The adoption of final version of " common rule" governing protection of human subjects for research sponsored by all federal agencies
1992 – PDUFA, the first FDA user fee program.
1993 – Second ICH Conference in Orlando.
1996 – Third ICH Conference in Yokohama.
1996 – Congress enacts HIPAA (Health Insurance Portabiality & Accountability Act) with provisions regarding privacy of human medical records.
1996-ICH GCP Guideline finalized
1997– FDAMA-pediatric studies & incentives (expanded under 2003 Pediatric Research Equity Act); clinicaltrials.gov, fast track approvals
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.