Regulations Impacting the Pharma Industry
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
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
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.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
