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PDA/FDA JRC to Explore Current FDA Thinking

by: David J. Cummings, US FDA, and Maria G. Jacobs, PhD, Pfizer | Mar 06, 2017

Each year, the PDA/FDA Joint Regulatory Conference provides a forum for the medical products industry to identify, discuss, and explore its unique challenges and opportunities. This conference addresses product quality, lifecycle management, innovation and regulatory developments for effectively delivering future medicines and innovative therapies.

Conference sessions engage regulators, their industry colleagues and other stakeholders in dialogue on topics of mutual interest. The meeting also explores how the US FDA regulates drugs, devices and biologics such that products can be moved to patients more quickly while also maintaining the gold standard for safety and effectiveness established by the Agency.

The 2017 conference will look at “Ensuring Product Quality in an Era of Innovative Therapies.” This year, advanced therapies such as cell and gene therapies, including regulations and submission expectations, will be a topic of discussion, as will combination products. Both are timely subjects for attendees.

Modernization of regulations and advances for innovative initiatives, such as cancer research, regenerative medicine, and continuous drug manufacturing will also be examined. Likewise, efforts to encourage integration of patient perspectives into the decision-making processes for drugs and devices will also be highlighted.

Industry endeavors to monitor quality control systems and processes and drive continuous improvement in drug manufacturing will also be explored.

In addition, attendees can look forward to the usual set of updates from each of the medical product areas within FDA on program-specific initiatives. The newly launched regulatory track session, to be held on Day 2 of the conference, will allow attendees to hear presentations directly from the Agency’s review staff regarding quality assurance and regulatory considerations for new drugs.

Join your colleagues this September in Washington, D.C.!

Learn more about the 2017 PDA/FDA Joint Regulatory Conference and subsequent PDA Education courses.