3月 | DIA新加坡年会，创新推动发展

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DIA新加坡年会

由DIA和CoRE共同举办

前瞻性解读药品开发各环节的创新和技术

从医疗IT解决方案到加速准入

DIA新加坡年会 提供思路和构想

塑造组织的未来

Scientific breakthroughs, growing amounts of healthcare data and globalization hold great promises for better health outcomes for patients in need. With the rapid utilization of information technology in health systems, there can be missed opportunities to align such initiatives among the different healthcare stakeholders to optimize the impact on public health. Data analytics, real-world evidence, remote clinical monitoring, connected health records, electronic labeling and mobile health apps are among some of the trending topics that will shape the healthcare landscape in the coming years. Alongside the advances in scientific understanding and health product development overall, paradigm shifts in regulatory processes and global convergence are important for greater synergy among all to bring forth timely innovation benefits to patients and consumers that will improve health outcomes.

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DIA-CoRE Singapore Annual Meeting 2019

- Advancing Health In Asia Through Innovation

Organised by DIA and CoRE

March 5-6, 2019

Grand Copthorne Waterfront Singapore

注册联系人：Youngshin

[e-mail]

展商和赞助机会：Kanchan

[e-mail]

Program Highlights

• Upcoming innovations and IT trends for bringing high quality healthcare closer to patients (medical technology, devices, e-labeling, real word evidence)

• Reducing barriers for timely access to new healthcare innovations (regulatory convergence, expedited/facilitated regulatory pathways, HTA, clinical trials)

• Exploring synergies among healthcare stakeholders (HTA, Market Access, health systems)

Who should attend?

• Industry professionals in Pharmaceuticals and Medical Technologies involved in Research & Development, Regulatory Affairs, Market Access and Medical Affairs

• Regulators and personnel from Health Authorities and Ministries

•  Academia and Researchers

PROGRAMME CO-CHAIRS

Dorothee GRIMALD

Director

Global Regulatory Policy 

MSD Singapore

James LEONG

Assistant Professor

Head of Education

Centre of Regulatory Excellence (CoRE) 

Duke-NUS Medical School

ADVISORY COMMITTEE

Jin SHUN 

Head, Regulatory Competency CenterAsia Pacific, Middle East and Africa (APMA)

Jing Ping YEO

Director, Research Integrity, Compliance and Ethics Singapore Health Services Ptd Ltd

Kum Cheun WONG 

Head Asia Pacific Regulatory & Development Policy, Novartis Asia Pacific Pharmaceuticals Pte Ltd

Lars Nelleman 

Owner

Lars Nelleman Consulting 

Pte Ltd

Vicky HAN 

Senior Director 

Policy Group Lead for Asia Pacific, Global Regulatory Affairs, Janssen Asia Pacific

PROGRAMME COMMITTEE

Finny Liu

APAC Regional Regulatory Policy Lead

PDR 

Roche, Singapore

Mei Ding

JAPAC Regional Lead, Regulatory Policy and Intelligence 

AbbVie Pte. Ltd

Audrey Ooi

Associate Director - Business 

Development 

Clinical Research Malaysia

Thean Soo (TS) Lo

Director – Asia Pacific Regulatory Policy Lead Global Regulatory Affairs

Janssen Asia Pacific J & J Singapore

MEETING MANAGER

Kanchan PATEL 

Associate Director Operations

DIA (India) Private Limited

cell: +91 90.2909.8844

[e-mail]

Sherna WADIA

Centre of Regulatory Excellence

Phone: [phone]

[e-mail]

VENUE DETAILS

Grand Copthorne Waterfront Hotel Singapore

392 Havelock Road, Singapore 169663 

T: [phone]

F: [phone]

W: www.grandcopthorne.com.sg

AGENDA | Day 1 | March 5, 2019

8:30–9:00

Registration

9:00–9:10

Welcome

DIA/ CoRE

9:10–9:20

Opening Remarks

Dorothee GRIMALD

Director, Global Regulatory Policy

MSD Singapore

Jin SHUN

Head, Regulatory Affairs

APAC

Sandoz

9:20–10:00

Keynote | Artificial Intelligence in Healthcare (including live demo)

Helmi ZAKARIAH

CEO

AIME, Malaysia

10:00–10:30

Break

Harnessing the Power of IT in Healthcare

Session Chair  James LEONG

Assistant Professor, Head of Education Centre of Regulatory Excellence (CoRE)

Duke-NUS Medical School

10:30–11:00

Introducing Self-Care and the Role of IT 

Ian Adams

Vice President - Regulatory Affairs, Asia Pacific, Middle East and Africa

GSK Consumer Healthcare

11:00–11:30

Healthcare Data Mining and Analytics 

Keren Priyadarshini

Regional Business Leader, WW Health Industry, Asia

Microsoft Asia

11:30–12:00

Managing your Future Health

Neal Liu

Founder and Chief Technical Officer

UCARE. AI

12:00–12:30

Panel Discussion and Q&A

12:30–13:30

Lunch

13:30 –14:00

Interactive Presentations: Artificial Intelligence in Medical Epidemiology (AIME)

Helmi Zakariah

CEO

Malaysia

Future of Patient Care

Session Chair  Finny LIU

APAC Regional Regulatory, Policy Lead, PDR

Roche, Singapore

14:00–14:30

Healthcare IT - Apps Enabling Community Healthcare/ Better Patient Care

Speaker Invited

14:30–15:00

Learning Healthcare System: Customizing Treatment with Big Data

Gracie Lieberman

Director

Regulatory Policy

Genentech

15:00–15:30

Digital Approaches to Labelling and the Relationship to Patient-centric Healthcare

Shimon YOSHIDA

Senior Director - Head

International Labelling Group

Pfizer

15:30–16:00

Break

Setting up a Digital Clinical Research Environment

Session Chair  Jing Ping YEO

Director, Research Integrity, Compliance and Ethics

Singapore Health Services Ptd Ltd.

16:00–16:20

Virtual Trials – a Patient-First Approach to Increase Probability of Study Success

David HOU

Head of MedTech Asia Pacific

IQVIA Asia Pacific

16:20–16:40

Use of RWE and Medical Records / eHR for Supporting Market Authorisation

Gau Churn-Shiouh

Chief Executive Director

Center for Drug Evaluation, Taiwan

16:40–17:00

Patient Partnering in Clinical Drug Development – Digital Transformation

Chng Wee Joo

Director

National University Cancer Institute, Singapore

17:00–17:30

Panel Discussion: Improvement of Health Outcomes through Delivery of Digital Healthcare Systems

• Virtual Clinical Trial

• Benefits for patients

• Privacy Risk in Data Sharing

17:30

Day Close

19:00

Faculty Dinner (By Invitation)

AGENDA | Day 2 | March 6, 2019

8:30–9:00

Welcome and Overview of Day 2

Supporting Innovation

Pharm & Bio

Chair: Mei DING

JAPAC Regional Lead

Regulatory Policy and Intelligence

AbbVie Pte. Ltd

Med Devices & Technology

Chair: TBD

9:00–9:30

Support to Quality Development in Early Access Approaches

Marta Parmar

Assoc. Director

Regulatory Affairs CMC GEM AsiaPac 

Biogen International GmbH

Innovative Data Collection and Advanced Data Analytics in Clinical Trial

Chen Zhiyang

Area Vice President for Professional Services

Medidata Solutions

9:30–10:00

Next Generation Antibody Drug Conjugates

Steve DAVIDSEN, PH.D.

Vice President - Oncology Discovery

AbbVie

Impactful Advances in Diagnostics: Case Study of a Fetal Heart Beat Monitoring Device

Amrish Nair

Founder and Director

Bio-rithm

10:00–10:30

Cell Therapies

John Connolly

Chief Scientific Officer

Tessa Therapeutics Pte Ltd

Cell Therapy Digital Ecosystem

Speaker invited

GE Healthcare

10:30–11:00

Break

11:00–11:30

Drive Botanical Drugs to World-class Development

May WEI 

Independent Consultant

eCTD as Global Standard and its Implications to Industry and Agencies

Silke NOLKEMPER

General Manager, Director Consulting APAC

EXTEDO China

11:30–12:00

Liposome for Targeting and Sustained Release in Clinical Use

Yun-Long TSENG

VP and RD head 

TLC 

Innovation in Track & Trace/Supply Chain through Blockchain

CoPresented by Speakers

MSD & SAP

12:00–13:00

Lunch

13:00–13:30

Interactive Presentation: Shopper Science Lab

Simon Bell

Shopper Science Lab Director – Asia, Middle East and Africa 

GSK

Facilitating Access to Innovation in Asia / Practical pragmatic approaches

Session Co-Chair  Thean SOO

Director, Asia Pacific Regulatory Policy Lead, Global Regulatory Affairs, Janssen Asia Pacific

J & J Singapore

13:30–13:50

Facilitating Regulatory Collaboration to Speed up Patient Access - Industry Perspective

Angelika JOOS

Executive Director, Global Regulatory Policy 

MSD Belgium

13:50–14:10

Support for Innovation and Accelerated access in the UK

Robert HEMMINGS

Manager- Licensing Division

MHRA

14:10–14:30

Re-imaging the Regulatory Paradigm for Digital Health

Lesley Maloney

Head, US Regulatory Policy

Roche Diagnostics

14:30–14:50

PMDA’s Activities to Promote Rapid Patient Access

Mari Shirotani

Division Director of Regulatory Cooperation, Office of International Programmes

PMDA Japan

14:50–15:10

Data Analytics for Active Surveillance

Ang Pei San

Regulatory Consultant, Vigilance & Compliance Branch, Health Products Regulation Group Health Sciences Authority

Singapore

15:10–15:30

Break

Session Co-chair  Audrey Ooi

Associate Director Business Development

Clinical Research Malaysia

(CRM)

15:30–16:00

Phase I Unit Accreditation for First In Human Studies in Malaysia 

Nicholas Leow Chun Wei

Head of Section GCP, Centre for Investigational New Product

NPRA Malaysia

16:00–16:50

Panel Discussion and Q&A

Facilitating efficient and effective regulation for timely access in Asia / ASEAN

– Need for parallel and coordinated reviews and multi-stakeholder collaboration, efficient regulatory management

• Personalised/ precision medicines and companion diagnostics

• Device-Combination products

• Good Regulatory Practice and Good Reliance practice

16:50

Closing Remarks

17:00

End

DIA Singapore Annual Meeting 2019 - Advancing Health In Asia Through Innovation Organised by DIA and CoRE

Event I.D. 83319 | March 5-6, 2019 | Singapore

VENUE: GRAND COPTHORNE WATERFRONT HOTEL SINGAPORE

392, Havelock Road, Singapore 169663

T: [phone]

F: [phone]

RESERVATIONS CONTACT

Conference rate for Delegates: Deluxe room SGD 210 ++ per room night (inclusive of daily buffet breakfast for 01 and internet access)

Kindly note that the rates are valid for booking till 20, February 2019 and subjected to rooms availability. Rates will be subjected to changes for any bookings after 20, February 2019.

Mr. Ian Tan | Assistant Sales Manager

Mobile: [phone]

[e-mail]

All rates are subject to 10% service charge and 7% goods and services tax (gst).

Please note that the gst is subject to change in accordance with the government policy.

Rates are quoted in singapore dollars on a per room per night basis.

MEETING MANAGER

Kanchan Patel

Associate Director Operations

DIA (India) Private Limited

cell: +91 90.2909.8844

[e-mail]

CANCELLATION POLICY:  ON OR BEFORE FEBRUARY 25, 2019

• Cancellations must be in writing and received by February 25, 2019. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations.

• DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

• UPON CANCELLATION, the administrative fee that will be withheld from refund amount is 25 % of the delegate fee

FULL MEETING CANCELLATION 

• All refunds will be issued in the currency of the original payment

For more details, please visit

www.DIAglobal.org

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DIA总部位于美国首都Washington DC，此外在北美、欧洲、日本、中国等设有分部。作为一家中立的国际组织，DIA 在制药和其它医疗健康领域，孜孜不倦50余年，为政府，工业和学术机构提供了形式多样的交流和学习的平台，赢得广泛认可和赞誉。 

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