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Internal audit on Medical Device QMS - ISO 13485:2016USD 111.99

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS). It is an essential standard for medical device development companies. Besides being a common regulatory requirement, this standard, when adhered to, provides a Quality Management framework that supports quality products and processes.
Certificate Courses

Quality Management
Published: 2021-06-01 06:34:57, updated 2021-08-08 23:43:07
USD 149.99
Medical Devices Quality Management System - ISO 13485:2016USD 111.99

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations. Furthermore, you can begin preparing your relevant set of documents for immediate implementation of your SOPs.
Certificate Courses

Quality Management
Published: 2021-05-31 13:33:44, updated 2021-09-19 15:40:52
USD 139.99
European Medical Device Regulation CourseUSD 250

The European Medical Device regulatory framework is undergoing a major change. Medical Device Directive (MDD) is being replaced by the Medical Device Regulation (MDR). This course helps the participants to understand what the new MDR entails and focusses on the important timelines within which the changes should happen.
Certificate Courses

Regulatory Management
Published: 2020-09-25 08:14:49, updated 2021-06-28 16:20:47
USD 500
Medical Device Regulatory Management CertificateUSD 250

This certificate course equips participants with a fundamental understanding of Medtech & Regulatory Affairs, backed by real-world practical examples. It is designed for regulatory practitioners, non-regulatory staff who collaborate with the regulatory team, or individuals considering a switch to the regulatory sector. Participants will learn the definition and classification of medical devices, global and regional regulatory environments, requirements in Asian countries, and key challenges and solutions in medical device regulations.
Certificate Courses

Regulatory Management
Published: 2020-04-20 04:00:41, updated 2021-09-19 15:42:22
USD 500
Introductory Course on Medical Device China CommercializationFree

Introduction of medical device mainland China commercialization, factors to be considered from feasibility study, company and location setup, product development, to registration testing, clinical trial and new market development. In addition, medtech registration Green channel and other possible expedite options will also be covered.
Specialised Topics

Regulatory Management
Published: 2021-04-21 08:50:51, updated 2021-06-28 16:18:18
How to get your Clinical Trial approved in Eastern EuropeFree

A 30 mins video showing you the clinical trial approval process, local ethics committee approval, import & expert licence requirement, pharmacovigilance requirement and tips to make it smoother or quicker. Sharing by experts from OCT Clinical.
Specialised Topics

Clinical Trial
Published: 2021-03-23 06:46:51, updated 2021-06-28 16:18:41
Medtech Career TalkFree

A MedTech Career sharing by experts in the industry, headhunter, academic with case studies. Anyone who wants to join the MedTech field will find this session helpful.
Introductory Topics

Career
Published: 2020-12-28 16:34:35, updated 2021-06-28 16:19:05
Medtech Distributor WebinarFree

This two-part MedTech distributor webinar focusses on giving a clear understanding of how distributors select what product they want to distribute and invest in and the important role they play in the distribution.
Introductory Topics

Distributor
Published: 2020-11-02 16:22:22, updated 2021-06-28 16:19:23
Overview of Traditional & Complementary Medicines and Its Regulatory ChallengesFree

Traditional & complementary medicines have been widely and increasingly used in both developed and developing countries, however it is not highly regulated and gaps exist between healthcare providers and National & Institutional efforts for integration. This course serves as an introduction to traditional & complementary medicines and its regulatory challenges designed for those who are interested to learn more about this industry.
Specialised Topics

Regulatory Management
Published: 2020-11-01 17:16:10, updated 2021-06-28 16:19:46
Crisis Management - Product RecallFree

The Asia Regulatory Professionals Association is collaborating with communications expert Wisse Kommunikatie (Worldcom PR Group) and language translation expert (MediqTrans) to establish a Crisis Management Alliance to share good practices on how to better manage this critical area.
Specialised Topics

Communications, Crisis Management
Published: 2020-10-11 17:03:29, updated 2021-06-28 16:20:25

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September 2021

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