Organization of Regulatory and Clinical Associates

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Organization of Regulatory and Clinical Associates

P.O. Box 3490

Redmond, WA 98073

Home Current/Future EventsWebinar - Medical Device Regulatory Special Access Routes for Malaysia and Singapore

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Today

Webinar - Medical Device Regulatory Special Access Routes for Malaysia and Singapore

When:

Wednesday, July 8, 2020, 8:00 AM until 10:00 AM

Where:

Webinar - link will be emailed to attendees 2 days prior to the meeting.

Event Contact(s):

ORCA Admin

Category:

Webinar

Registration is closed

RSVP by Tuesday, July 7, 2020

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.

Please make sure that the following email address is in your Safe Sender list: mailer@mail2.clubexpress.com. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this email address.

You will receive an email 2 days prior to the meeting date with the webinar login instructions or after payment is processed if registering closer to the meeting date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.

PAID FEES ARE NON REFUNDABLE.

For webinar events, payment is REQUIRED at the time of registration.

Capacity:

100

Active Member (Regular, Student, Government)

No Fee

Non-Member

$60.00

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The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.

NEW START TIME is 8:00 AM PST

NOTE: There will be no Q&A session at the end of this pre recorded webinar due to the time zone difference with the speaker. Requests for presentation slides and questions can be sent to the speaker via email after the meeting.

TOPIC: Medical Device Regulatory Special Access Routes for Malaysia and Singapore

TOPIC DESCRIPTION: This webinar is the first in a series on ASEAN markets created to provide you with a clearer picture on how to navigate the expedited access pathways to register, import and distribute medical devices during the COVID-19 outbreak and beyond.

Overview of current situation
How standard registration compares to the Special Access Routes (SAR)
Which medical devices are included in SAR?
Who can import?
Overview of the SAR procedures and timeframes to market
Distribution routes

SPEAKERS: Shouzheng Tan & Jhelum Bandyopadhyay

SPEAKERS BIOGRAPHIES: Shouzheng is our Regulatory Affairs Specialist for Malaysia and he is also our internal Quality Assurance Manager. Shouzheng holds a Bioprocess Engineering degree from Universiti Malaysia Perlis (UniMAP) and has comprehensive experience in clinical data evaluation and technical data interpretation in addition to his excellent knowledge of the medical device industry from registration through to post-market surveillance.

Jhelum is our Regulatory Affairs Specialist for Singapore and has over 7 years’ experience in medical device product registrations, post-market surveillance and regulations in Singapore. She holds a specialized degree in Medical Device Regulatory Affairs from the National University of Singapore and RAPS Online University in addition to her Biotechnology degree and MBA.

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1 point towards RAC re-certification