Submitted by admin on Wed, 09/25/2024 - 08:58

The 2nd GHWP (Guangzhou) Academy Training Notice

(1st round notice)

 

To further enhance the regulatory capacity of member countries and regions of the Global Harmonization Working Party (GHWP) and to promote innovation in medical devices to support global public health, the GHWP will hold the 2nd GHWP (Guangzhou) Academy training from November 23 to November 26, 2024. Please find the relevant arrangements outlined below:

 

I. Training Theme

“Innovative Medical Device Promotes Global Public Health”

Medical devices are a crucial foundation for healthcare and public health, directly affecting the safety and health of individuals. This training will focus on the innovation and development of high-end medical devices, including pre-market and post-market regulation of active medical devices. The training will focus on specific industry sectors, cutting-edge technologies, and regulatory practices. Frontline regulators and top experts will be invited to present.

 

II. Training Organization

Organizer: GHWP (Guangzhou) Academy

Co-organizer: Guangdong Association For Medical Devices Industry (GAMDI)

 

III. Training Dates and Venue

Training Dates: November 23-26, 2024 (Registration on November 23, departure on November 26)

Training Venue: TBD

 

IV. Training Methods and Content

Training Method: This program will combine lectures, penal discussions, Q&A sessions, case studies, hands-on training, and parallel exchanges. The morning session on November 24 will be available via live global streaming.

 

Training Content: Based on the needs collected by the GHWP (Guangzhou) Academy, five major training topics (Symposia) will be set, along with one hands-on training session, totaling 24 academic hours over three days. Each topic will include lectures and panel discussions.

 

  • Topic 1: GHWP Promotion of Global Medical Device Regulatory Convergence, Coordination, and Trust (4 hours).

This topic will feature GHWP leadership introducing the progress of GHWP’s work in the fields of regulatory convergence, coordination, and trust in the global medical device sector.

  • Topic 2: Regulation Requirements and Common Issues for Active Medical Devices in China (4 hours)

This session will invite authoritative experts from the National Medical Products Administration of China to explain up-to-date regulatory laws regarding active medical devices and relevant requirements for non-clinical and clinical data review, addressing common industry concerns.

  • Topic 3: Innovation and Regulation in the Medical Robotics Industry (4 hours)
  • Topic 4: Innovation and Regulation in the High-end Medical Imaging and Therapeutic Equipment Industry (4 hours)
  • Topic 5: Innovation and Regulation in the Artificial Intelligence Medical Device Industry (4 hours)
    Topics 3, 4, and 5 will feature renowned international experts discussing current trends in technology innovation and industry development, with representatives from regulatory agencies of multiple countries and regions introducing pre-market and post-market regulatory requirements for high-end medical devices.

 

V. Target Audience

  1. Individuals engaged in the R&D of innovative medical devices, global expansion of the medical device industry, and international regulatory cooperation.
  2. Specifically invited representatives from medical device regulatory authorities and industry representatives of GHWP member countries/regions.
  3. Specifically invited members from governing bodies of the GHWP (Guangzhou) Academy.

 

VI. Certificate of Completion

At the end of the training, the GHWP (Guangzhou) Academy will hold a ceremony to award participants with an unified completion certificate issued by the GHWP.

 

VII. Training Fees

Regulatory authorities of the GHWP members are entitled to 1-2 free training slots.

Members of the GHWP (Guangzhou) Academy Council will receive corresponding discounts according to the council's regulations.

Participants in the 1st training will enjoy a discounted fee.

Other participants will be charged RMB 9,800 per person, which covers tuition, materials, and meals (accommodation and transportation are self-arranged).

 

Ⅷ. Contacts

GHWP (Guangzhou) Academy: Ms. Sifan Wang, +86-13143128423, sylviawangsifan@ibmd.org.cn

Guangdong Association For Medical Devices Industry (GAMDI): Ms. Haiwei Ma +86-13632328457

 

GHWP (Guangzhou) Academy

 Sept 24, 2024