Are you ready to implement the QRM requirements that are included in the soon-to-be-released EudraLex Annex 1 Document? Are you aware that the International Conference in Harmonization is planning on revising ICH Q9 to provide guidance on the applications of QRM concepts?
Whether you answered yes, no, or I’m not sure, you should plan on attending the 2019 PDA Quality Week, Dec. 9-13 in Washington, DC, an information-packed week focusing on the complex subject of Quality Risk Management (QRM).
The Week is comprised of three unique, individual but contiguous events designed to educate attendees on all aspects of QRM. This new approach to conference and workshop offerings is designed so that there’s something for everyone - you can attend one, two, or all three events, depending on your specific needs.
Each event during the Week provides a different perspective on QRM.
The 2019 PDA Risk Management in the Regulatory Landscape Conference, Dec. 9-10, will start off the week with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept from industry and regulators’ perspectives.
The 2019 PDA Building a Foundation and Culture for Quality Risk Management Integration Workshop, Dec. 11, will encourage attendees to actively participate in defining successful risk management applications that can be translated to the workplace.
The 2019 PDA Optimizing Quality Risk Management Conference, Dec. 12-13, highlights the challenges and opportunities an organization faces when designing and implementing a holistic QRM program.
Don’t miss the exciting lineup of noted QRM thought leaders who will present throughout the week:
- From the U.S. FDA: Dr. Janet Woodcock, Dr. Gregg Claycamp, Melissa Burns, and Dr. Lucinda Buhse
- David Churchwood, MHRA
- Guy Villax, CEO, Hovione
- Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck & Co., Inc.
- Martin VanTrieste, Immediate Past Chair, Board of Directors, PDA, and CEO of Civica Inc.
- Dr. Martin Nemec, Health Canada
- Dr. Anne Green, Professor, Lecturer, and Pharmaceutical Project Manager, TU Dublin, School of Chemical and Pharmaceutical Sciences
- Hal Baseman, Chief Operating Officer, ValSource, LLC
One highlight of the week will be an interactive session where attendees will have the opportunity to dialogue directly with members of the ICH Q9 Working Group to offer industry perspective and considerations for inclusion into this document’s revision.
The 2019 PDA Quality Week promises to be one today’s most comprehensive programs addressing QRM. Don’t miss this unique opportunity to interact with industry thought leaders and provide input on how QRM requirements should be addressed and implemented by our industry. |
