Submitted by admin on Thu, 06/27/2024 - 12:59

Capacity Building-Free online training on e-IFU and e-labelling by Mr. Sharad Shukla on 3rd July 2024

Time: 3rd July 2024 / 14:00 (SGT, UTC/GMT +8 hours)

For All GHWP members

As part of the GHWP/GHWP Capacity Building program, we are pleased to announce an upcoming Free online training via Zoom on [Overview of e-IFU and e-labelling by Mr. Sharad Shukla, GHWP WG1 & WG3 member and Director Regulatory Affairs of Johnson & Johnson MedTech.

In this training on electronic Instructions for Use (e-IFU) and electronic labelling (e-label), you’ll gain an overview of GHWP’s updated guidance document on GHWP/WG1-WG2-WG3/F002:2023- Principles of Regulatory Requirements for Electronic Instructions for use (eIFU); comprehensive understanding of the global regulations and guidelines related to e-IFU, as well as navigate the requirement and benefits associated with e-labelling.

No registration is required for this online training. Target audiences, regulators and industry who are interested, are welcome to join with the Zoom access as follows:
 

Zoom link: https://us06web.zoom.us/j/83220879766?pwd=H7IihMFC5O6OXVsXxI3SdX1bERgQuk.1

Meeting ID: 832 2087 9766

Passcode: 824845

 

Should you have any enquiry, please contact the GHWP Secretariat at secretariat@ghwp.info

 

Agenda

Time

(SGT, UTC/GMT +8 hours)

Topic

Speaker

14:05-14:10

Greetings & Opening

Dr. Seil Park

WG1 Chair

14:10-14:40

Overview of e-IFU and e-labelling

  1. Introduction of the Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)

  2. Regulatory practices of eIFU in specific markets- Current approaches and requirements

  3. Regulatory practices of eIFU in MDR

Mr. Sharad Shukla

14:40-14:50

Q&A

14:50-15:00

Closing Remark

Dr. Seil Park

WG1 Chair