IMDC 2019

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: Mdm Ir. Sasikala Devi a/p Thangavelu Mr Yusuf Bin Mohd Johari 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

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Time	Topics and Presenters
2.00 – 2.20pm	New Approach of Cartilage Development Assoc. Prof. Dr. Ardiyansyah Syahrom, Director, Medical Devices and Technology Centre (MEDITEC) School of Mechanical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
2.20 – 2.40pm	Biomechanics Research on Cancellous Bone Assoc. Prof. Dr. Ardiyansyah Syahrom, Director, Medical Devices and Technology Centre (MEDITEC) School of Mechanical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
2.40 – 3.00pm	Biodegradable Porous Bone Scaffolds for Cancellous Bone Replacement Dr. Amir Putra Md Saad, Research Fellow, Medical Devices and Technology Centre (MEDITEC) School of Mechanical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
3.00 – 3.20pm	Tissue Vascularization Dr. Norhana Jusoh, Research Fellow, Medical Devices and Technology Centre (MEDITEC) School of Biomedical Engineering,Faculty of Engineering, Universiti Teknologi Malaysia
3.20 – 3.40pm	Simulation of Trabecular Bone Through Fluid Structure Interaction Approach Dr. Rabiatul Adibah Abdul Rahim, Post-doctorate Researcher, Medical Devices and Technology Centre (MEDITEC), School of Biomedical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
3.40 – 4.00pm	Artifical Glenoid Labrum: New Generation of Glenoid Implant Dr. Abdul Hadi Abdul Wahab, Post-doctorate Researcher, Medical Devices and Technology Centre (MEDITEC), School of Biomedical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
4.00 – 4.20pm	New Design of Ankle External Fixator Dr. Muhammad Hanif Ramlee, Deputy Director, Medical Devices and Technology Centre (MEDITEC) School of Biomedical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
4.20 – 4.40pm	Electrochemical Evaluation of Polyphenols for Rapid Identification of Pure Honey Dr. Norjihada Izzah Ismail, Research Fellow, Medical Devices and Technology Centre (MEDITEC) School of Biomedical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia
4.40 – 5.00pm	Breathing Pattern Analysis Using Thermography Technique Dr. Asnida Abd Wahab, Research Fellow, Medical Devices and Technology Centre (MEDITEC) School of Biomedical Engineering, Faculty of Engineering, Universiti Teknologi Malaysia