HORSHAM, PA.—The DIA Quality Risk Management in Clinical Drug Development Workshop: Fundamentals and Practical Aspects will be held December 3-4, at the Sheraton Philadelphia Downtown Hotel, 201 North 17th St., in Philadelphia. Attendees will examine two concepts that are new to the clinical trial environment—Quality by Design and Quality Risk Management—and how they may be applied to clinical trials, safety reporting, and clinical development programs.
“These concepts have been essential in identifying and managing important risks to quality in industries such as aviation, automotive and pharmaceutical manufacturing, and they are now emerging as vital principles in the clinical trial sphere,” said DIA Program Chairperson, Dr. Peter Schiemann. “This workshop will provide the information needed to build a strong foundation for implementing quality by design and quality risk management in the drug development process.” The workshop will begin with Jean Mulinde, Senior Adviser for the Division of Good Clinical Practice Compliance (GCP), Office of Scientific Investigations at the Food and Drug Administration, and Kenneth D. Schiff, President of Quality Risk Management Associates LLC, exploring the role of risk management from both the regulatory and business perspectives. The first day will focus on the practical aspects of implementing a risk-based approach in clinical drug development, and the second day will center on current guidelines and provide updates on the Clinical Trials Transformation Initiative (CTTI). Workshop sessions will include:
• Conducting Clinical Trials/Site Monitoring, presented by Brian J. Nugent, Associate Director, Clinical Operations, Gilead Sciences;
• Reporting Clinical Trial Data, presented by Jean Mulinde, Senior Adviser, Division of GCP Compliance, Office of Scientific Investigations, CDER, FDA, and Ann Meeker-O’Connell, Acting Associate Director, Division of GCP Compliance, CDER, FDA;
• Current Initiatives and Updates on CTTI, presented by Ann Meeker-O’Connell, Acting Associate Director, Division of GCP Compliance, CDER, FDA; and Briggs W. Morrison, Head of Global Medicines Department, AstraZeneca.
Register for Quality Risk Management in Clinical Drug Development Workshop: Fundamentals and Practical Aspects.
ABOUT DIA: DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. www.diahome.org. Follow DIA on Facebook, Twitter, LinkedIn, and YouTube. Stay updated on hot topic news at #druginfoassn on Twitter.
