Learn to manage the GDUFA landscape at our CMC Workshop | Association for Accessible Medicines
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Learn to manage the GDUFA landscape at our CMC Workshop

The FDA’s Office of Pharmaceutical Quality (OPQ) describes its mission as “the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale,” with a motto of “One Quality Voice.”

Every year, our Chemistry, Manufacturing & Controls (CMC) workshop helps participants to stay on top of the latest developments in this field. The theme of year’s workshop, which takes place May 23-24 in Bethesda MD, is “Innovative Approaches, Exciting Opportunities.”

This Year’s Workshop Will Focus On How Industry And FDA Can Work Towards Increasing Firstcycle Approvals. Industry And FDA Leaders And Experts Will Be On Hand To Share Their Unique Perspectives On Topics Ranging From Comparability Protocols And Complex Products To Data.

Lisa Parks, R.Ph, AAM’s Vice President, Sciences & Regulatory Affairs

Michael Kopcha, Ph.D., R.Ph, Director of the FDA’s OPQ, delivers the keynote address the morning of Tuesday, May 23. AAM’s CEO Chip Davis will offer his insight into industry trends.

See the 2017 CMC agenda here. Sessions will focus on OPQ’s lifestyle approaches, first cycle approvals, and quality metrics, along with an “Industry Corner,” which presents, as case studies, on topics like Drug-Device Combo Products and active pharmaceutical ingredient (API) Starting Material.

In the midst of a constantly changing environment for generic pharmaceuticals, this is a chance to take part in discussions among industry leaders and key officials from FDA. Professionals will gain critical insight into how the Generic Drug User Fee Amendment (GDUFA) landscape is changing, OPQ’s current thinking regarding facility assessments, CMC regulatory quality requirements, and the soup to nuts process of Abbreviated New Drug Application (ANDA) Quality Recommendations and Expectations.

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