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Welcoming Remarks from the Associate Commissioner for Regulatory Affairs to the PIC/S Committee

Melinda Plaisier, U.S. Food and Drug Administration Associate Commissioner for Regulatory Affairs
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee Meeting

September 24, 2018

It is my sincere privilege and pleasure to welcome all of you to the 2018 Pharmaceutical Inspection Co-operation Scheme Committee meeting.  I would like to recognize PIC/S Chairman Boon Meow Hoe, the PIC/S Executive Bureau, PIC/S Secretariat, partner organizations, and committee members.

As host, and on behalf of the U.S. Food and Drug Administration’s (FDA) Commissioner of Food and Drugs, Dr. Scott Gottlieb, and the FDA delegation, I want to welcome you to the United States and to Chicago. We extend our best wishes for a successful committee meeting.  As a former Chicago resident, I hope you enjoy your time here in the Windy City.

As public health colleagues, you know that the work we do to protect public health is critical, and we also work hard to strike a balance between regulating and innovation.  When U.S. FDA was established more than a century ago, its regulated industries were mostly local.  The world has changed for all of us in so many ways, including the staggering number of imported drugs coming in to our respective markets.

Supply chains and globalization have created tremendous challenges as we work to ensure that regulated products are properly manufactured, distributed and stored, and that the products provided to our communities and patients are safe and effective.

As public health inspectorates, we share goals and challenges:

  1. We must work together to harmonize drug inspection programs across all sites of manufacture, domestic and foreign, so that we can inspect regulated products in the same way. Common training will be one way to work toward addressing that goal.
  2. As science, technology, manufacturing, and production continue to evolve at a record pace, we also need to encourage adoption of emerging technologies to strengthen our inspectional approaches and assessments so that we can stay a step ahead of the industries we regulate. This is another challenge where common training can help us keep abreast of industry advancements.
  3. The globalization of the manufacturing industry and supply chain is simply huge and no one inspectorate can inspect it all.  Wherever possible, inspectorates need to share information and discuss our respective regulatory decisions in ways where we can learn from each other.

This means enhancing our workforce and culture, improving our core operations, leveraging and expanding our partnerships like PIC/S, and improving our IT infrastructures that support the vital work we do to protect public health.

PIC/S has made tremendous progress building collaborations among pharma inspectors.  The impact that you have had on harmonizing the inspectors who enforce the regulations of GMPs and GDPs cannot be overstated.

And, while more work is to be done in PIC/S efforts to establish The Training Academy, it is an extremely important collective investment.  The motto says it all, “Inspection Excellence through Harmonized Training.”  The newly formed working group on third-party funding that is being developed to explore grants and other dedicated funding can offer PIC/S new opportunities as inspectorates work to align GMP and GDP inspectional approaches.

The U.S. FDA strongly supports the development of a training curriculum for inspectors.  And, we are committed to contributing our technical expertise and support to the working group and training sub-committee.

It is essential that we foster continuous quality improvement by investing in our workforce to meet the growing regulatory challenges such as emerging technologies and continuous manufacturing operations.

For U.S. FDA’s inspectorate, our workforce is our most valuable resource.  We not only invest heavily in training and development, but also continually assess our operations, continue investments in our quality management system, and ensure that our investigators have the tools they need to carry out their important responsibilities.

Advancing U.S. FDA’s inspectorates’ core operations include confronting the increasing volume of opioids coming into the United States through our import operations, improving efficiency in our risk-based inspections, and, when necessary, taking prompt and effective enforcement actions.

Expanding FDA’s public health partnerships does intersect with the PIC/S organization.  I have long been a champion of advancing functional reliance on information we receive from global regulatory partners.  For many years I had the privilege to serve as the Associate Commissioner for International Programs, leading FDA’s global office.

During my tenure, we constituted the first-ever confidentiality agreement with a foreign partner, and today FDA has a wide portfolio of confidentiality agreements that facilitate important information sharing.  I also had the privilege of leading the work that laid the foundation for the establishment of U.S. FDA global offices where we now have inspectors stationed in China and India.  My commitment to and belief in the importance of public health, regulatory, and law enforcement partnerships is deep and strong.

At U.S. FDA, we have come a long way with our global partnerships, and recent legislation passed by our congress has sparked the expansion of public health partnerships such as the Mutual Reliance Agreement that was signed with the European Union in 2017.  The driving force was the need to use our limited resources efficiently, assigning them to the highest-risk areas — something, I am sure we, as regulators, all strive to do.

I want to commend you on the PIC/S Road Map 2018–2020 and delineating priorities.  In reviewing the PIC/S roadmap goals, I was struck by how closely they are aligned with ORA’s goals for the FDA’s pharmaceutical inspectorate, which also emphasize training and development, specialization of inspectors, and increased information sharing with all partners, including federal and state partners.

Some of the recent notable work products, such as Guidance on Good Practices For Data Management and Integrity in Regulated GMP/GDP Environments, will help us all as we tackle the challenge of protecting public health, and the road map is a robust framework for guiding our collaborations in the future.

I’m honored to be with you today.  On behalf of the entire U.S. FDA delegation, we are proud and privileged to host this important meeting.

As public health colleagues, we must work together to ensure that PIC/S facilitates meaningful regulator-to-regulator collaborations that further our mission on behalf of patients, protecting public health in the communities we serve.

Thank you for the work you do every day and for your commitment to this important collaboration.  I appreciate the opportunity to welcome you this afternoon and look forward to hearing the outcome of your deliberations.

Page Last Updated: 10/01/2018
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