Time: 27th August 2025, 16:00-17:30 (GMT +8)
For All GHWP members
As part of the GHWP Capacity Building program, we are pleased to announce an upcoming free online training via Zoom on Change Management by Dr. Adelheid Schneider and Mr. Sharad Shukla on 27th August 2025.
Dr. Adelheid Schneider
Consultant Regulatory Affairs and Quality, Coach and Mentor
Experience leading working groups within international forums and Industry Organizations (nominated as Chair for the IVD WG and Vice Chair in the Regulatory Leading Committee at APACMed from 2018 till 2023), and appointed as GHWP IVD WG2 Co-Chair in 2022.
Mr. Sharad Mi Shukla, RAC
Director Regulatory Affairs, MedTech
(APAC Digital Regulatory Policy, Regulatory Affairs SEA)
Sharad Mi. Shukla is a seasoned MedTech professional with over twenty years of progressive experience in Design & Development, Manufacturing, Regulatory, Quality & Clinical Affairs.
Currently, he is the Director of Regulatory Affairs at J&J MedTech, where he leads MedTech Regulatory Affairs of SEA and APAC Digital Regulatory Policy.
Prior to his tenure at J&J, Sharad led regulatory strategies for global product launches, divestitures, and acquisitions at GE Healthcare. He also served as an ISO 13485 and CE Marking lead auditor for medical devices at various European certification/notified bodies. Throughout his career, he has been involved with multiple start-ups, playing an instrumental role in establishing Quality and Regulatory functions from the ground up.
With a strong passion for training and capacity building, Sharad actively engages in regulatory shaping and advocacy through different industry forums. He currently chairs ‘Regulatory Affairs Committee’ of APACMed, a regional MedTech industry forum. He is also an active member of WG1 (Pre-market) and WG3 (Digital Health) of GHWP, AdvaMed, AmCham and other regional/ global forums. In the past, Sharad has held leadership roles within APACMed as the Chair of SEA Centre of Excellence, Capacity and Capability Building Workgroup (CCBWG) and the Lead of the Digital Health Database under the APACMed RA Committee.
Sharad holds an MS in Microbiology and certified in Regulatory Affairs by the Regulatory Affairs Professional Society (RAPS) and holds both the RAC-US and RAC-EU certifications. Sharad has also made contributions to several RAPS publications and engaged across industry as thought leader.
The training supports the participants to understand the GHWP guideline Change Management for registered Medical Devices GHWP/WG2-WG1-WG3/F001:2024
After the training the participants
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:
Time: Aug 27, 2025 16:00-17:30 (GMT +8)
Zoom link: https://us06web.zoom.us/j/86736775791
Meeting ID: 867 3677 5791
Agenda
Should you have any enquiry, please contact the GHWP Secretariat at secretariat@ghwp.info