Regina Freunscht worked in international clinical research for pharmaceutical companies and CROs in various positions since 1989. She works for Accovion, a European Full-Service CRO, as Director Marketing and Communications and is a member of the company's Management Team.
Jean Mulinde is a Medical Officer in the Division of Good Clinical Practice Compliance, Office of Scientific Investigations (Office of Compliance, CDER). Before joining DSI, she was a Lead Medical Officer in the Division of Anti-Infective and Ophthalmology Products (Office of New Drugs, CDER).
James Huang, Forest Research Institute, United States
Dr. Huang has more than 17 years of proven records in pharmaceutical, biotech and medical device industries specialiized in Quality Assurance, regulatory compliance, and validation. His clients include major pharma companies such as Eli Lilly, Abbott Lab, Novartis, Johnson & Johnson, Purdue Pharma.
Peter is pharmacist and human biologist by education. He has 11 years of industry experience in Switzerland and the US, 4 years in R&D Strategy consulting in Switzerland and the US and 3 years in academic research in Germany. Currently he is Managing Partner of Widler & Schiemann Ltd in Switzerland.
Description
This session facilitates the development of a systematic, prioritized, risk-based approach to quality management of clinical trials that supports the principles of GCP and complements existing quality practices, requirements, and standards.
Learning Objectives: Discuss approaches to clinical trial oversight Identify the critical aspects of trials that should be the focus on to create quality systems Describe an integrated model of quality management that will promote more efficient approaches to design, conduct, and oversight of clinical trials.