Good morning. I’m delighted to join you today to help kick off this 11th Global Summit on Regulatory Science (or GSRS).  I wish we could be together in person.

I would like to acknowledge the Global Coalition for Regulatory Science Research (GCRSR), co-chaired by William Slikker, head of FDA’s National Center for Toxicological Research and Marta Hugas, of the European Safety Authority for co-hosting this conference.

I also want to thank the GSRS21 organizing committee, co-chaired by Weida Tong, of NCTR and FDA and Primal Silva of the Canadian Food Inspection Agency for arranging such an exciting program.

In the decade that we’ve been holding these GSRS meetings, we’ve continued to see a rise in globalism and, particularly, its impact on the safety of medical products and the food supply. 

The COVID-19 pandemic has underscored this effect, making abundantly clear how interconnected the world is, and the impact this interrelationship can have on medical product and food supply lines.

Each of the regulatory agencies gathered here share critical responsibilities in their own countries for the oversight of drug and food safety.  Each of us have worked individually and together to respond to these changes, both related to the pandemic and otherwise.  

What all of us understand is that to make the most informed, effective, responsive, and predictable regulatory decisions we need the best rigorous science and data and strong collaboration. 

This global summit was created in part to encourage and support this kind of collaboration and dialogue.  Among its goals is to provide a forum for discussing the various innovative technologies, approaches, and partnerships that are needed to translate science into effective regulatory policy.

Indeed, the Global Summit on Regulatory Science has provided a platform to hep initiate those communication among our global regulatory agencies and has contributed significantly to regulatory science research in the global setting.

We have harnessed and applied important advances in fundamental research, as well as developments in science and technology, particularly in the area of data analytics and emerging technology, to help us make enormous strides and keep pace with global changes.

The essence of regulatory scientific research is to develop, refine, and translate these innovations and advancements for their potential application in regulatory decision-making.

As you understand, it’s not enough just to produce groundbreaking scientific developments. It’s our job to make sure these promising developments are translated into meaningful products that can make a difference for patients and consumers.

This process is a meticulous and a dynamic one.  It involves the continual acquisition, review, and evaluation of the data and evidence on which we base our decisions.  The global environment in which we operate today, only expands the challenge.

All of which brings me back to the importance of communication among our global regulatory agencies. 

At this meeting each year, we’ve focused on one or more important emerging issues.

For example, last year’s conference addressed emerging technologies, and also touched on the application of Artificial Intelligence (AI).

This year, we’re taking the next step in that direction, with an even greater focus on AI and real-world data (RWD), each of which offers enormous opportunities for the work we do.

A goal of this meeting is to develop a broader perspective and direction for evaluating the recent advances in both AI and RWD.  If successful, we will be able to further modernize regulatory function, improve regulatory efficiency, and facilitate even greater collaboration and coordination among global agencies. 

I know that many of us have already been applying recent advancements by industry and academia in AI and RWD to improve operations and strengthen regulatory mechanisms for approving the products containing these innovations.

Both AI and RWD have demonstrated the potential to add another dimension to support our increased understanding of drug safety and efficacy profiles.  And RWD has shown the potential to provide unprecedented ability to improve food and drug safety.

If we can construct a pathway to expand the opportunities for utilizing these innovations, we can further broaden their application to additional regulatory issues. 
 
We all understand the enormous challenges we face today.  But I’m optimistic that many of the same obstacles that arise from the nature of the global marketplace also offer the opportunity for global solutions.

This conference offers a unique platform to develop some of those solutions by facilitating the discussion and collaboration across global agencies.  Through this conversation we can modernize our regulatory operations and help provide the necessary oversight to ensure that these applications will improve public health.

Thank you again for your participation in this year’s meeting. 

We have an exciting and stimulating agenda, and we look forward to the discussions and the opportunities to interact with each other and with the presenters from the various regulatory agencies and academia from across the globe.

Thank you again, and I wish you a productive meeting.