CDER’s Office of Pharmaceutical Quality is Opening New Regulatory Pathways to Span Its Broad Responsibilities and Global Reach

The “strategic priorities” of the Office of Pharmaceutical Quality (OPQ) for the next few years speak to the wide breadth and global reach of its regulatory responsibilities, and to OPQ’s willingness to open new pathways to fulfill them.

The breadth, depth and progressiveness of OPQ’s programs were well-articulated in the keynote presentation on OPQ by its Office of Policy for Pharmaceutical Quality (OPPQ) Director Ashley Boam at the Association for Accessible Medicines (AAM) GRx+Biosims 2018 Conference, held in Bethesda, Maryland in September.

She highlighted the four primary strategic priorities that will be guiding OPQ’s operations in 2018-2022 and explored the actions the office has been taking, and is planning to take, going forward to coherently implement them.

The four priorities are: ● strengthening OPQ’s collaborative organization ● promoting availability of better medicines ● elevating the awareness and commitment to the importance of pharmaceutical quality, and ● strengthening partnerships and engaging stakeholders.

Boam’s office, OPPQ, is actively involved in developing science- and risk-based quality policy and standards related to review and inspections for drugs and combination products, and in coordinating OPQ’s work with international regulatory authorities, pharmacopeias, and standard setting organizations.

Prior to joining CDER in 2013, Boam spent almost 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH) – first serving as a scientific reviewer, then as branch chief in the Division of Cardiology Devices, and finally as associate director for regulations and guidances for ODE.

Boam’s extensive device experience is a valuable foundation for her to have in helping CDER explore new quality regulatory approaches for pharmaceuticals, and in addressing the challenges of combination products, in particular. It helps explain her being placed in a leadership role as “rapporteur” in the ICH Q12 effort to create a more viable and harmonized approach to regulating post-approval changes at the global level that can better accommodate the continuous improvement mandate central to the device regulatory paradigm.

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