CONFERENCE OUTLINE


Time Details
8.00-9.00am Registration / Networking Break & Exhibition Area Visit
9.00-11.30am

Opening Ceremony by Tun Dr Mahathir, YAB PM

11.30-12.15pm

ASIAN Harmonization on Medical Device

Speaker: Ms. Quan Tran, AHWP Vice-Chair (Industry), Head of Regulatory & Government Affairs and Quality Assurance Asia Pacific, Invisalign Singapore Pte Ltd, Singapore

11.30-12.15pm

Top Global Research Trends in Medical Devices

Speaker: Dr. Eng. Nazeeh Shuja Alothmany, World Health Organization (WHO) Medical Devices Expert

12.15-1.00pm

Challenges of the New EU MDR for Medical Device Companies

Speaker: Mr. Thomas Stefan Brand, Vice President Quality Management for non-active Medical Devices, Hospital Care Division, B. Braun Melsungen, Germany

1.00-2.15pm Networking Break & Exhibition Area Visit
  Track 1: Regulatory Requirements Track 2: Medical Device Research Environment Track 3: State of The Arts
2.15-2.45 pm

Towards Implementation of ASEAN Directive in Malaysia

Speaker: Madam Ir. Sasikala Devi a/p Thangavelu, Director, Policy, Code & Standard Division, Medical Device Authority, MoH

Delivery Clinical Research within Speed, Reliability and Quality

Speaker: Dr Akhmal Yusof Chief Executive, Clinical Research Malaysia (CRM)

Robotics in Healthcare: Trends and Possibilities

Speaker: Dr Ogan Gurel, Invited Professor at DGIST & Chief Scientific Officer at Field Robot Technology (FRT)

2.45-3.15pm

Harmonization of Standards in Medical Device Regulatory Requirement in ASIAN

Speaker: Mdm Salbiah Binti Yaakop, Head of Policy & Industrial Support Branch, Medical Device Authority, Ministry of Health Malaysia

Clinical Data for Medical Device to Meet Medical Device Authority Regulatory Requirements

Speaker: Dr. Lim Teck Onn, former Clinical Research Centre (CRC) Director

Retrofit Magnetic resonance imaging (MRI)

Speaker: Mdm Ir. Maya binti Abdullah Maamuom, Principal Assistant Director, Biomedical Operation Section, Engineering Services Division, Ministry of Health Malaysia

3.15-3.45pm

Identifying Errors and Mis-Interpretations of the ISO13485:2016 Standard and How to Overcome Them.

Speaker: Mr Ee Bin Liew, Owner, Access-2, Healthcare

Ethical Requirement in Doing Health Technology Research

Speaker: Dr Hjh Salina Abdul Aziz, Chairperson of Medical Research Ethics Committee (MREC)

Advances in Diagnostic Imaging Devices

Speaker: Prof. Dr. Ng Kwan Hoong, Senior Professor at the Department of Biomedical Imaging, University of Malaya

3.45-4.15pm

Change Management for Medical Devices

Speaker: Dr Adelheid Schneider, Regional Head Regulatory Affairs & Quality Asia Pacific, Roche Diagnostics Asia Pacific Pte Ltd

Regulatory Control on Safety and Performance of Medical Device Research

Speaker: Mdm Aidahwaty M.Olaybal, Director of Technical Evaluation, Medical Device Authority, Ministry of Health Malaysia

IEC PAS 63077 “Good Refurbishment Practice of Medical Imaging Equipment” & Regulations for Refurbish ed Medical Devices in the USA, EU, Japan and ASEAN countries

Speaker: Mdm Patricia Gehrlein, Vice Chair, DITTA Good Refurbishment Practice Working Group

4.15-4.45pm

Panels Discussion

Moderator: Dr. Vincent Lam Chee Choong, Senior QMS Lead Auditor / Head of Medical Device Certification Scheme, TUV SUD Malaysia Sdn. Bhd

Panels Discussion

Moderator: Dr. Lim Teck Onn, former Clinical Research Centre (CRC) Director (TBC)

Panels Discussion

Moderator: Mr Ahmad Shariff Bin Hambali, Chief Executive, Medical Device Authority Malaysia

4.45pm-5.00pm Networking Break & Exhibition Area Visit
Time Details
8.00-9.00am Registration
9.00-9.45am

Global Strategy for Digital Health

Speaker: YBhg. Datuk Dr. Noor Hisham Bin Abdullah, Director General, Ministry of Health Malaysia

9.45-10.00am Networking Break & Exhibition Area Visit
10.00-10.45am

Asia-Pacific Economic Cooperation (APEC) : Strategic Approach Towards Regulatory Harmonization

Speaker: TBC

10.45-11.30am

Accelerating Innovation Across Healthcare

Speaker: Mr. Gabriel Sim, Director, Business Development, Asia Pacific Medical Technology Association (APACMed)

11.30-12.15pm

Spearheading Healthcare Innovation with Internet of Things and Big Data

Speaker: Mr Jaffri Ibrahim, Chief Executive Officer of CREST

12.15-1.00pm

Supporting Innovation and Faster Access to Safe Medical Devices

Speaker: Dr Zhong Yanxin, Health Products Regulation Group, Medical Devices Cluster, Health Science Authority Singapore

1.00-2.15pm Networking Break & Exhibition Area Visit
  Track 4: Digital Health Track 5: Safety & Performance Data For Medical Device Track 6: New Regulatory Updates
2.15-2.45 pm

Digitalization of Healthcare: Key Trends In Healthcare

Speaker: Mr Rod Frazer, Managing Director, Siemens Healthineers

Good Laboratory Practice based on OECD for Medical Device

Speaker: Dr Jahangir Kamaldin, Senior Lecturer & Lead Advisor Bioassay for Chemical Safety and Quality Assurance, University Sains Malaysia (USM)

Briefing on New Regulations

Topic: Re-registration Requirements Speaker: Mr Yusuf Bin Mohd Johari, Director of Registration, Licensing and Enforcement Division, Medical Device Authority, Ministry of Health Malaysia

Topic: Prohibition Order and Advertisement Speaker: Mdm Ir. Sasikala Devi a/p Thangavelu, Director, Policy, Code & Standard Division, Medical Device Authority, Ministry of Health Malaysia

Topic: Post-Market, Surveillance and Vigilance (PMSV) and Enforcement Speaker: Mdm Idamazura Binti Idris @ Harun, Head of Post-Market Branch, Medical Device Authority, Ministry of Health Malaysia

2.45-3.15pm

Internet of Things (IoT) in Managing Non-Communicable Diseases (NCD

Speaker: Dr. Feisul Idzwan Dato’ Mustapha, Consultant Public Health Physician and Deputy Director (NCD) Non-Communicable Disease Section Disease Control Division Ministry of Health, Malaysia

Biocompatibility Report Submission for Regulatory Approval

Speaker: Dr. T.S. Kumaravel, American Board Certified & UK Registered Toxicologist; Chairman, GLR Laboratories Pvt Ltd

3.15-3.45pm

Digital Therapeutics and The Expected Development of Chronic Condition Management

Speaker: Mr Dinesh Sampath Rangaraj, Vice President, Business Unit Leader, Frost & Sullivan

Test Available for Biocompatibility in Accordance with ISO10993

Speaker: Prof. Dr. Nor Fadilah Rajab, Laboratory Director Makmal Bioserasi, University Kebangsaan Malaysia

Group Discussion

Topics to be discussed:

  • Re-registration
  • PMSV
  • Prohibition Order
  • Advertisement
  • Conformity Assessment Issues
3.45-4.15pm

The Future of Digital Health: Exploring New Regulatory Paradigms

Speaker: Mr Varun Veigas, Regional Manager (Asia Pacific)-Regulatory Affairs Roche Diagnostics Asia Pacific Pte Ltd

Screening Test Evaluation for Infectious Diseases

Speaker: Dr Ravindran Thayan, Unit Head of Virology, Institute for Medical Research

4.15-4.45pm

Panels Discussion

Moderator: Dr Aida binti Basri, Program Director, Digital Healthcare, CREST

Panels Discussion

Moderator: Mdm Mariammah A/P Krishnasamy, Head of Registration Unit, Medical Device Authority, Ministry of Health Malaysia

Panels Discussion

Moderator: Mr Ahmad Shariff Bin Hambali

MDA Panellists:

  1. Mdm Ir. Sasikala Devi a/p Thangavelu
  2. Mr Yusuf Bin Mohd Johari
  3. Mdm Idamazura Binti Idris @ Harun
4.45pm-5.00pm Networking Break & Exhibition Area Visit
Time Details
9.00-9.45am

Healthcare Management in Malaysia, The Way Forward

Speaker: YBhg. Dato' Seri Dr. Chen Chaw Min, Secretary General, Ministry of Health Malaysia

9.45-10.00am

Networking Break & Exhibition Area Visit

10.00-10.45am

Health Technology Assessment (HTA) 101 – Applying HTA Data for Medical Device Innovations

Speaker: Mr. Eric Woo, Regional Director, Asia Pacific ECRI

10.45-11.30am

Adverse Events Terminology

Speaker: Mr Hiroshi Ishikawa, Chair of IMDRF & Adverse Events Terminology Working Group

11.30-12.15pm

Single Window Concept

Speaker: Mdm Eva Zahra, Head Section of Class A Medical Device, Directorate of Medical Device and Household Health Product Evaluation, Ministry of Health, Indonesia

12.15-1.00pm

Point-of-Care Medical Devices in Malaysia

Speaker: Professor Ir. Dr. Fatimah binti Ibrahim, Director, UM Centre of Innovation & Commercialization (UMCIC)

1.00-2.15pm Networking Break & Exhibition Area Visit
  Track 7: Combination Products Track 8: Medical Procedures & Safety Data Track 11: Research Paper Presentation Competition

[Collaboration with Medical Devices And Technology Center (Meditec), University Technology Malaysia (UTM)] Click here to view the schedule

2.15-2.45 pm

An Overview of Malaysian Requirement for Drug-Device Combination Product

Mdm Mariammah a/p Krishnasamy, Head of Registration Unit, Medical Device Authority, Ministry of Health Malaysia

Challenges in Managing the Evolving Medical Device

Speaker: Ir. Dharmesh R Doshi, Associate Director, Asia Pacific ECRI

2.45-3.15pm

An Overview of the Global Regulatory Landscape for Drug-Device Combination Product

Speaker: Mr Tim Chesworth, Senior Director Medical Devices and Combination Products, AstraZeneca United Kingdom

Assessing the Value of Innovative Medical Device

Speaker: Dr Izzuna Mudla Mohamed Ghazali, Public Health Physician/Head of Unit, Horizon Scanning, Communication and Information Unit, Malaysian Health Technology Assessment Section (MaHTAS), Medical Development Divison, Ministry of Health Malaysia

3.15-3.30pm

Panels Discussion

Moderator: Mdm Janice Tan, Head of Regulatory Affairs, Novartis Corporation (Malaysia) Sdn Bhd

Challenges to Implement the Regulatory Requirements based on Conformity Assessment Body Perspectives (TBC)

Speaker: Mr Kenny Chong Khin Khen, Branch Manager/Healthcare Technical Lead, BSI Services Malaysia Sdn Bhd

3.30-3.45pm Networking Break & Exhibition Area Visit
  Track 9 : Capacity Building  
3.45-4.15pm

Centre of Regulatory Excellent (CoRE)

Speaker: Madam Ir. Sasikala Devi a/p Thangavelu, Director, Policy, Code & Standard Division, Medical Device Authority, MoH

Minimally Invasive Thoraic Surgery on Endoscopic Thoraic Sympathectomy

Speaker: Dato’ Dr Ahmad Farouk Musa, Former Surgeon at Institute Jantung Negara, A lecturer/researcher at Monash University

4.15-4.45pm

Maximize Learning Experiences with An Innovative E-Learning Solution

Speaker: Mdm Angeline Tay, Application & Education Manager (DX), Siemens Healthcare Sdn Bhd

Aesthetics Medical Device and Non-Medical Aesthetics Devices: Differences and Similarities in Relation to Medical Device Act 737

Speaker: Dr. Ungku Mohd Shahrin Bin Mohd Zaman, Member of Aesthetics Medical Practice Committee (AMPC)

4.45pm-5.00pm

Panels Discussion

Moderator: Mdm Yasha Huang, Director, Regulatory Affairs, Asia Pacific Medical Technology Association (APACMed)

Q&A Session