INTRODUCTION

This one-day online training course is to provide an in-depth understanding of the Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice to assist sponsors, investigators, ethics committees, clinical research professionals and other stakeholders involved in the conformity assessment of medical devices.

This training aims to help participants in understanding the scope and use of ISO 14155:2020 in complying with the Medical Device Regulations.

The training provides standard guidance to medical device manufacturers and clinical research professionals for how to implement Good Clinical Practice (GCP) for pre- and post-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. Certificate of attendance will be given to the participants.

OBJECTIVES

To provide an overview and interpretation of the clauses of ISO 14155:2020
To understand the scope and use of ISO 14155:2020 in meeting the requirements of Medical Device Regulations
To highlight the importance of ISO 14155:2020
To improve the understanding of the requirements of ISO 14155:2020

TARGET AUDIENCE

Medical device manufacturers;
Quality managers and regulatory affairs personnel;
Other Medical Device Industry players;
Clinical Research Professionals;
Anyone involved with the implementation of the ISO 14155:2020 standard; and
Interested individuals.

TRAINING OUTLINE

Date (Day)	18 October 2022 (Tuesday)
Time	9.00 AM – 5.00 PM
08.30 AM	Registration
08.50 AM	Briefing
09:00 AM	Overview of ISO 14155 Requirements 1. Scope 2. Normative references 3. Terms and definitions 4. Ethical considerations
10:30 AM	Break
10:45 AM	5. Clinical investigation planning 6. Clinical investigation conducts
12.00 PM	7. Suspension, termination and close-out of the clinical investigation
1:00 PM	Lunch Break
02.30 PM	8. Responsibilities of the sponsor
03.30 PM	9. Responsibilities of the principal investigator
04.30 PM	Q & A
05.00 PM	End of Training

OUR TRAINER

Mr. Alvin Chen Neng, LEE

CEO, InnoSignum Sdn Bhd, Malaysia

Experienced in clinical trials management of phase II/III/IV trials, registry and Bio Equivalence (BE) studies for pharmaceutical products, biologics and medical devices. Therapeutic area experiences in clinical trials includes respiratory medicine, nephrology, neurology, ophthalmology, oncology, cardiology, rheumatology, hematology, gynaecology, gastroenterology and genetics.

Possess in-depth knowledge in regulatory affairs, quality assurance and clinical operation activities (i.e. development and implementation of study protocols, feasibility surveys/studies, monitoring of sites and study close-out). Experienced in establishing businesses involving medical devices, from research and development (R&D) to product registration and commercialization in Malaysia.

REGISTRATION AND TRAINING FEE

The closing date for registration is on the 13^rd of October 2022.
Training fee per participant: RM 1,000.00
To register, please click HERE
Upon acceptance of the Registration, an invoice (for payment purposes) together with details of the payment method will be issued accordingly
Registration of participants will be on a first-come-first-served basis.
Limited to 150 participants.
Upon payment confirmation, MDA will provide a link to join the training program.

CONTACT

For enquiries, please contact trainingpackage@mda.gov.my or 03-8230 0395 / 0355 / 0211 / 0240 / 0343.

Updated: 19th September 2022