welcome speech

The 1st Boao International Conference on Real World Research on Pharmaceutical Devices will be held at the Boao Forum for Asia Conference Center on April 26-27. The meeting was hosted by the Hainan Provincial People's Government, supported by the State Drug Administration, and organized by the Boao Lecheng Pilot Area Administration, the Hainan Provincial Drug Administration, the Hainan Provincial Health Commission, and the China Food and Drug International Exchange Center.

The role of real-world research (RWS) in drug device R&D and regulatory decision-making is increasingly recognized, and it is increasingly attracting the attention of drug device companies and regulatory agencies around the world. It will also provide a new direction for the reform of China's drug device review and approval system. At present, my country's exploration in the field of RWS is developing steadily and rapidly. In order to meet the needs of development, give full play to the policy of the Hainan Free Trade Port, the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the "Lecheng Pilot Zone"), the policy of urgently needing imported pharmaceutical devices, and the Drug and Medical Device Regulatory Scientific Research Base of the State Food and Drug Administration (Hainan Provincial Real World Data Research Institute) and the country's first real world data research and evaluation key laboratory and other resource advantages, with the Lecheng Pioneer Area as the permanent venue, the annual "Boao International Pharmaceutical Equipment Real World Research Conference" will be held.

The theme of this conference is "Real-World Data Research and Innovative Development of Drug and Device Supervision". The conference will set up a main forum on "Real World Data Research and Innovation and Development of Pharmaceutical Device Supervision", and eight parallel forums, bringing together domestic and foreign drug regulatory agencies, scientific research institutions, experts and scholars, societies, associations, pharmaceutical device companies and other resources to jointly build real world data research. Innovation and development platform for drug device supervision.

It is hoped that through the "Boao International Medical Device Real World Research Conference", the construction of the real world data platform will be promoted, to meet the development needs of the industry, to show phased results, to further amplify the benefits of the real world data application pilot, and to promote the real world research application in the field of pharmaceutical devices in China and around the world. Provide new methods, new standards, and new paths for regulatory decision-making. The "Boao International Real World Research Conference on Pharmaceutical Devices" is willing to make a voice, build consensus, form a plan, and think, plan and act together with regulators, industry, academia, medical institutions and other parties, so as to promote RWS to become a new engine for the development of my country's pharmaceutical industry!

Boao Lecheng welcomes you!