Industry Expert Learning Series HRDF SBL Claimable
Post Market Surveillance, Vigilance and Adverse Event Reporting for Medical Devices
Date : 23-24 November 2015 Time : 9am - 5pm Venue : Kuala Lumpur (hotel to be advised)
Enjoy Early Bird Course Fees when you register by 9 October 2016. Early Bird (AMMI Members) - RM1,200 per pax Early Bird (Non Members/ Public ) - RM1,400 per pax
NORMAL COURSE FEES AMMI Members - RM1,400 per pax Non Members/ Public - RM1,600 per pax Note : Price stated is not inclusive of 6% GST
DURATION : Two (2) full days INTRODUCTION The medical device industry is governed by various quality system requirements and regulations of different countries. Post-Market Surveillance (PMS), Vigilance and Adverse Event Reporting are vital in ensuring Medical Device Regulatory compliance and are an essential component of ISO 13485 Quality Management System.
COURSE OBJECTIVES This course is designed to enable you to identify proactive and reactive sources of information which are a regulatory requirement to be incorporated in post-market surveillance procedures applicable to all medical devices (including IVD’s). By developing a post-market surveillance plan you can target the right sources of post-market information will ensure continued regulatory compliance and identify user requirements enabling continued product development. This course also highlights the importance of PMS as an integral part of a company’s Risk Management cycle (ISO 14971) as well as the practical applications and integration into the lifecycle of a medical device.
Understand the regulatory requirements for Post-Market Surveillance (PMS) including recalls, field advisory notices and vigilance; and how these are interpreted in ISO 13485, ISO 14971 and various GHTF/IMDRF guidance documents.
Identify the responsibilities for responsibilities for PMS
Create procedures for PMS and Vigilance
Identify sources of information for PMS (proactive) and Vigilance (reactive)
Implement cost effective and targeted post-market clinical follow-up using various tools and techniques.
Recognize when a complaint needs to be reported as an adverse event or incidents.
TARGET AUDIENCE Key persons involved in defining, planning, or implementing Post-Market Surveillance, Vigilance, Adverse Event Reporting and Customer Complaint Handling activities:
Clinical affairs specialists
Complaint handling specialists
Design and development professionals
Authorized Representatives, Importers, Distributors and Manufacturers
PRE-REQUISITES Basic knowledge of medical devices, ISO 13485, medical device regulations would be beneficial but not essential.
DURATION Two (2) full days
PAYMENT Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please refer the following bank account details: Beneficiary Name: Medsociate Sdn Bhd Bank Account Number: 800 3930 348 Bank: CIMB Bank Swift Code: CIBB MYKL Please email us (firstname.lastname@example.org) the bank-in slip / remittance slip once the payment is made.
For Government Sector A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : email@example.com
SUBSTITUTION Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347