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Regulatory Affairs

navigating the increasingly complex and fragmented regulatory landscape

APACMed’s Regulatory Affairs Committee is the Association’s largest committee, counting over 250 dynamic and engaged senior regulatory professionals.

Part of the impetus behind the creation of the APACMed in 2015, was the need to help MedTech industry navigate the increasingly complex and fragmented regulatory landscape. APACMed provides access to actionable regulatory intelligence for its members, advocates for harmonised regulatory requirements where possible across Asia Pacific countries through capacity building and best practice sharing, and promotes regional and global convergence by securing a seat at the table with key harmonisation platforms, building thought leadership in prioritized areas, as well as fostering long-term partnership with regulatory authorities, peer associations, academia and industry.

APACMed’s Regulatory Affairs Committee is the Association’s largest committee, counting over 250 dynamic and engaged senior regulatory professionals.

Much of the regulatory advocacy efforts across the region coalesce around in market based Centres of Excellence, covering: China, Korea, South East Asia, the Indian Sub-Continent. Separate Regional Working Groups are dedicated to regulatory intelligence (RI), capacity building (CB), and invitro diagnostics (IVD). Through its Centres of Excellence and Working Groups, APACMed has successfully engaged members and fostered its networks at the local level across the region.

APACMED RA VISION AND STRATEGIC PILLARS

It is our vision to become the leading regional regulatory partner to improve patient access to safe, effective and innovative medical technologies.

CONVERGENCE

Promote regulatory convergence in collaboration with government agencies, industry associations, academia and other stakeholders

CAPACITY BUILDING

Build and support a strong regulatory workforce for MedTech industry and regulators and drive capacity building initiatives in partnership with various stakeholders

ADVOCACY

Advocate for policies that promote patient access to innovative technologies that advance patient outcomes

INTELLIGENCE

Create actionable insights for a rapidly changing regulatory landscape to support members strategic decisions

REGULATORY AFFAIRS COMMITTEE STRUCTURE

Objectives of the Regulatory Affairs Functional Committee:

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OUR LEADERSHIP TEAM

Lance_Little

Lance Little

MANAGING DIRECTOR, REGION ASIA PACIFIC
ROCHE DIAGNOSTICS ASIA PACIFIC
Board Sponsor
Miang_Tanakasemsub

Miang Tanakasemsub

Head of QA Commercial & Regulatory Affairs, APAC
Cardinal Health
Regulatory Affairs Committee Chairperson
Adelheid_Schneider

Adelheid Schneider

Regional Head for Regulatory and Quality
Roche Diagnostics
Regulatory Affairs Committee Vice-Chairperson
Jason_Guo

Jason Guo

APAC Director, Regulatory Affairs, Quality and Compliance
Abbott
Regulatory Affairs Committee Vice-Chairperson
Nishith_Desai

Nishith Desai

Director of Regulatory Affairs
Medtronic
Regulatory Affairs Committee Vice-Chairperson
Alex_Budiman

Alex Budiman

Vice President of Regulatory Affairs
BD
Regulatory Affairs Committee Vice-Chairperson

CHINA CENTRE OF EXCELLENCE (CoE)

Echo_Liu

Echo Liu

Regulatory Affairs Director
Baxter
China Centre of Excellence Chairperson
unknown_user_woman02

Crystal (Nie Jing)

RA Director, APAC
Johnson & Johnson
China Centre of Excellence Vice-Chairperson
Victoria_Qu

Victoria Qu

Director of Regulatory Affairs
Abbott
China Centre of Excellence Vice-Chairperson
Fan BU

Bu Fan

Roche
China Centre of Excellence Secretary

SOUTHEAST ASIA (CoE)

Priscilla_Koh

Priscilla Koh

Lead-Director, Regulatory Affairs
Johnson & Johnson
Southeast Asia Centre of Excellence Chairperson
Yenny_Angorro

Yenny Anggoro

Director – RA & QA
Stryker ASEAN
Southeast Asia Centre of Excellence Vice-Chairperson
Yu_Hosokai

Yu Hosokai

REGULATORY AFFAIRS MANAGER - SEA
COOK SOUTH EAST ASIA
Southeast Asia Centre of Excellence
Vice-Chairperson
Kenneth Cheong

Kenneth Cheong

RA & QA Manager
ConvaTec
Southeast Asia Centre of Excellence Secretary

INDIA (CoE)

Kirti_Arora

Kirti Arora

Associate Director Regulatory Affairs and Quality Assurance
Boston Scientific
Indian Subcontinent Centre of Excellence Chairperson
gaurav

Gaurav Verma

Director, Regulatory and Government Affairs
BD
Indian Subcontinent Centre of Excellence Vice- Chairperson
Prashanth

Prashanth Prabhakar

Sr. Manager - Regulatory Affairs
Teleflex Medical
Indian Subcontinent Centre of Excellence Vice- Chairperson

KOREA (CoE)

Lisa_Park

Lisa Park

Head of RA & Market Access
Alcon
Korea Centre of Excellence Chairperson
Justin_Yea2

Justin Yea

Senior QRA Program Manager
Medtronic
Korea Centre of Excellence Vice-Chairperson
Leslie_Kim

Leslie Kim

Senior Manager
Stryker
Korea Centre of Excellence Vice-Chairperson
Lena_Kim2

Lena Kim

RA Director
Cook Medical
Korea Center of Excellence Secretary

REGULATORY INTELLIGENCE (WG)

James_Chan

James Chan

Manager – RA & QA, Southeast Asia+ South Korea
Varian Medical
Regulatory Intelligence Working Group Chairperson
Shivkumar_Hurdale

Shivkumar Hurdale

Senior Director – RA & QA, APAC
Stryker Asia Pacific
Regulatory Intelligence Working Group Vice-Chairperson
Jane_Lin

Jane Lin

Head of ASPAC Regulatory Affairs
Johnson & Johnson Medical
Regulatory Intelligence Working Group Vice-Chairperson
Muhammad_Sohail

Muhammad Sohail

Manager – RA & Pharmacovigilance QREM
Fresenius Medical Care, Pakistan
Regulatory Intelligence Working Group Secretary

IN-VITRO DIAGNOSTICS (WG)

yasha2

Yasha Huang

Regional Regulatory Affairs and Policy Lead
Roche Diagnostics Asia Pacific
In-Vitro Diagnostics Working Group Chairperson
Jacqueline_Monteiro

Jacqueline Monteiro

Associate Director, Regulatory Affairs
Abbott
In-Vitro Diagnostics Working Group Vice-Chairperson
20170214_204911

Nashata Isa

Senior Regulatory Affairs Specialist
Qiagen
In-Vitro Diagnostics Working Group Secretary

CAPACITY BUILDING (WG)

Sharad_Shukla

Sharad Shukla

Head Regulatory Affairs
Johnson & Johnson
Capacity Building Working Group Vice-Chairperson
Kazuhiro_Iwasaki

Kazuhiro Iwasaki

Chief
Terumo
Capacity Building Working Group Vice-Chairperson
Marianne_Yup

Marianne Yap

Head, Regulatory & Government Affairs, APAC
Alcon
Capacity Building Working Group Vice-Chairperson
Tanushree_Ghatak

Tanushree Ghatak

QRA Manager India
Cardinal Health Medical Products India Pvt. Ltd.
Capacity Building Working Group Secretary
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