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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:
  • Build and support a strong regulatory workforce for MedTech industry and regulators, and drive capacity building initiatives in partnership with various stakeholders
  • Promote regulatory convergence in collaboration with government agencies, industry associations, academia and other stakeholders
  • Advocate for policies that promote patient access to innovative technologies that advance patient outcomes
  • Create actionable insights for a rapidly changing regulatory landscape to support members strategic decisions

OUR LEADERSHIP TEAM

Lance_Little

Lance Little

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

Miang Tanakasemsub

Regional regulatory affairs and Government Affairs head
Alcon
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
Guo_Ye

Guo Ye

Senior Director, Regulatory Affairs & Compliance
BD
China Centre of Excellence Chairperson
Victoria_Qu

Victoria Qu

Director of Regulatory Affairs
Abbott
China Centre of Excellence Vice-Chairperson
Echo_Liu

Echo Liu

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

Bu Fan

Roche
China Centre of Excellence Secretary
Priscilla_Koh

Priscilla Koh

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

Joyce Tan

Regulatory Affairs Director
BD
Southeast Asia Centre of Excellence Vice-Chairperson
Audrey_Lee

Audrey Lee

Associate Director
CryoLife
Southeast Asia Centre of Excellence Vice-Chairperson
Kenneth Cheong

Kenneth Cheong

RA & QA Manager
ConvaTec
Southeast Asia Centre of Excellence Secretary
Kirti_Arora

Kirti Arora

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

Asok Kumar

Director, Strategic Global Regulatory Affairs
Abbott
Indian Subcontinent Centre of Excellence Vice-Chairperson
Latika_Vats

Latika Vats

Director of Regulatory Affairs & Quality Assurance
Medtronic
Indian Subcontinent Centre of Excellence Vice-Chairperson
Sahjogita Kathuria

Sahjogita Kathuria

Director RA & QA
Terumo
Indian Subcontinent Centre of Excellence Secretary
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
Renee_Cotta

Renee Cotta

Director, Quality & Regulatory Affairs
Boston Scientific
Regulatory Intelligence Working Group Chairperson
Rhoel_Laderas2

Rhoel Laderas

Senior Regional Regulatory Affairs Manager
Baxter
Regulatory Intelligence Working Group Vice-Chairperson
Yenny_Angorro

Yenny Anggoro

RA & QA Manager
Stryker
Regulatory Intelligence Working Group Vice-Chairperson
Dacia Su

Dacia Su

Regional RA Manager
Abbott
Regulatory Intelligence Working Group Secretary
Jacqueline_Monteiro

Jacqueline Monteiro

Associate Director, Regulatory Affairs
Abbott
In-Vitro Diagnostics Working Group Chairperson
Lai_Pai_Lin

Lai Pai Lin

Head of Quality and Regulatory
Siemens
In-Vitro Diagnostics Working Group Vice-Chairperson
Rose_Yu2

Rose Yu

Senior Director RAQA
Hologic
In-Vitro Diagnostics Working Group Vice-Chairperson
20170214_204911

Nashata Isa

Senior Regulatory Affairs Specialist
Qiagen
In-Vitro Diagnostics Working Group Secretary
unknown_user_man01

N/A

N/A
Capacity Building Working Group Chairperson
Sharad_Shukla

Sharad Shukla

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

Mariana Gebara-Coghlan

Director, Regulatory Affairs
Baxter
Capacity Building Working Group Vice-Chairperson
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