OVERVIEW
Medical devices have evolved to be a critical area within the
Healthcare sector. According to the Health Sciences Authority (HAS),
medical devices cover over 8000 types of products, ranging from simple
bandages to life maintaining implantable devices, and minimally
invasive surgery equipment. Singapore, for example, has three phases
for implementation of regulatory control for medical devices to
minimise disruption of the supply chain distribution and ensure
sufficient time for companies to register their devices and meet the
requirements.
Navigate through the different phases of medical device regulations
with this workshop as we dive into the global and regional regulatory
environment.
In this course, participants will learn:
* The definition and classification of medical devices
* The global and regional regulatory environment
* The requirements in Asian countries
* The key challenges and solutions in medical device regulations
AGENDA
9:30AM – 10:00AM: Registration
10:00AM – 12:00PM: Medical Device Fundamentals
* Definition of Medical Device
* Classification of Medical Devices
* Global and Regional Regulatory Environment
12:00PM – 1:00PM: Lunch
1:00PM – 4:00PM: Key Challenges and Solutions in Asia
* Requirements in Asian Countries
* Challenges and Solutions in Medical Device Regulations
4:00PM – 4:45PM: Open Book Examinations
4:45PM – 5:00PM: Closing Comments and Q&A
TRAINER
JACK WONG
Jack has over 20 years of Regulatory, Clinical Trial and
Pharmacovigilance experience in Asia with extensive knowledge in the
fields of Medical Devices, Pharmaceuticals, Nutritional, Consumer
Healthcare and Biological products.
Externally, he plays a leading role among all the regional regulatory
professionals in the Asian Harmonisation Working Party (AHWP). He was
also invited to provide regulatory training to local universities and
industry organisations. Jack has also been very active in ASEAN, APEC,
ISO and WHO projects.
In his professional career, Jack developed the First Asia Regulatory
Affairs Certificate in 2007, which has since garnered more than 1400
alumni. He founded the Asia Regulatory Professional Associations
(ARPA) since 2010, and it now has over 1200 members. He also founded
the Asia Good Regulatory Practice Research Centre in 2011 with the
support of over ten companies. Jack is also the author of The First
Asia Regulatory, launched in May 2012.
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18/09/2019 Last update