AHWP UpdateGrowing from Strength to Strength

Tran QuanAHWP Vice-Chair (Industry)

Head of APAC RAGAQA, Align24 Oct 2018

AHWPChair Malaysia

Vice-Chair ChinaVice-Chair Tran Quan

Technical CommitteeChair Saudi Arabia

Co-Chair South KoreaCo-Chair Alfred Kwek

Advisory Panel to TC

Working Groups

Secretariat Team AHWP ASL

Asia Harmonization Working Party2018 - 2020

AHWP New Term

AHWP Global Partnership

IMDRF Meeting, Shanghai 19-21 March 2018

• GS1 training workshop

• Participation in AHWP meetings to present on updated works done by GS1

• Participation in APACMed Forum

• Contribution to AHWP workshop & capacity building training

• Annually holding an AHWP-DITTA joint workshop

• Active participation in AHWP TC working group activities

AHWP Activities with Liaisons

AHWP Website Enhancement New AHWP Website for Easier Access and Better Communication

Our Capacity Building Journey

2014 2015 - 2017 2018

Launch Competency Framework for MedTech Regulators

A joint initiative of AHWP, APACMed and Deloitte

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Member Economy Feedback

We are working with Deloitte using a survey based assessment

Identify structure and key activities of regulatory bodies from multiple sources, e.g. RAPS, WHO, regulatory agency websites

Validate initial hypotheses by incorporating insights from AHWP working group

Develop initial hypotheses on the set of competencies and skills that are most important and relevant for the improvement effort

Draft survey questions for MedTech companies and Regulators

Launch 2 sets of surveys:• AHWP self-assessment• MedTech companies’ expectation

Develop Regulator Competency Framework by analyzing responses from 2 sets of surveys

Finalize AHWP Competency Framework

Run webinar to present the finalized Competency Framework

Final deliverable

1 2 3

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Develop White-paper

We are here today

While foundational skills are considered as important across all economies, three distinct groups of competencies emerge across level of importance

C6

L5

L1

L2

L4

L3

L6

O2C3

O5

O6

O7C1

MS5

MS1

C2I1

M1

M2

MS4M3

M4 O4

MS2MS6

C5

M7M9

M10

M8

I3

M6

C4O1

I2

M5

O3

MS3

1 Quality Mgmt. system2 Project Mgmt.3 Risk Mgmt.4 Crisis Mgmt.5 People Mgmt.6 Mentoring & Coaching7 Training8 Leadership

9 Good Regulatory Practice

10Policy Analysis

1 Code of conduct

2 Critical Thinking & Problem Solving

3 Budget Planning & Management

4 Documentation & Filing

5 Customer Service6 IT Skills

7 Technical Report Writing

1Understand & assess Legal documents (local)

2 …Legal documents (international)

3Understand & assess Technical documents (local)

4 …Technical documents (international)

5 Understand Legislative process

6 Legal writing

Legal Operation

1 Effective Communication

2 Public Speaking3 Interpersonal Skills4 Negotiation

5Information Dissemination & Media Strategy

6 Public Education

Communication Management

1 Foreign Languages & Culture

2 Diplomatic and Foreign Affairs Policy

3 Healthcare Ecosystem

4 Stakeholder Engagement

5 International Initiatives and networks

6 Public Health

Industry Insights

1 Local industry landscape

2 Emerging technologies and products

3 International industry landscape

Multisector partnership

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Level of importanceMedium High Critical

1

General technical skills are considered important, however capability and understanding of regulatory principles are critical

SE6

SE9

SE7RP4

SE1

SE2

SE3

RP1

SE5

RP10

SE4

SE8

RP2

RP3RP5

RP6RP7RP8RP9 RP11

1 Differences -Pharmaceuticals, General MDs & IVDs2 Combination and Borderline Products3 Risk Classification4 Essential Principles of Safety & Performance5 Device Nomenclature Systems (GMDN/UMDNS)6 Device Labelling & Unique Device Identifier (UDI)7 Conformity Assessment Concepts and Principles8 Post-marketing Surveillance System9 Supply chain integrity10 Local Standards11 International Standards

1 Human Anatomy and Physiology2 Biological Science3 Biochemistry4 Biomaterials5 Nanomaterials6 Biomechanics7 Bioelectronics8 Radiation and Nuclear Medicine

9 Digital Technology (mobile health, telemedicine, AI, etc.)

Scientific & Eng. Principles Regulatory Principles

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Level of importance

Medium High Critical

2

…Skills and Capabilities required to undertake regulatory activities across Medical Device product life-cycle have been ranked across four levels of importance by member economies

DC2

DC1

MC10

MC11

DC3 PM3

PM2

DC7DC6PM1

DC5

DC4PM4

PE5

PE4 PE3

PE2

PE1

CO1PE6

CO2

LT5

CO4LT3

LT4

MC3

LT1

CO5

MC2

MC1

LT2

CO6

CO3

MC7

MC5MC4

MC6MC9

MC8

1 Intl. MD Rqmts. In Quality system (QS)

2 GMP (loc.)3 GMP(Intl.)4 QS auditing skills5 Loc./Intl. standards

6 Design validation / verification methods

7 Risk Mgmt. Principles8 Mfg.Process & Tech. 9 Calibration/Metrology 10Cleanroom process11Refurbishment of MDs

1 Declaration of Helsinki & Nuremberg Code

2ISO 14155 Clinical Investigation of MD for Human Subj.

3 Good Clinical Practice (ICH)

4 Good Clinical Practice (Local)

5 Clinical Evaluation (Evidence Based)

6 Statistics

1 International MD Rqmts.

2 Device Registration Unit / Grouping Principles

3 Submission Dossier Format and Content

4 Declaration of Conformity Rqmts.

5 Device Change Management

6 General Device Safety & Performance

Pre-Market Clinical Oversight1 Good Laboratory Practice

2 Laboratory Quality Management System

3 Occupational Health and Safety Standards

4 Relevant local test standards

5 Relevant international test standards

Laboratory testing Manufacturing control

1 Good Distribution Practice

2 Quality System auditing skills

3 Risk Management principles

4 Import/export regulations (loc.)

5 Import/export regulations (Intl.)

6 Disposal of MDs

7 Environmental considerations

Post Market

1Intl. MD reqmts. in Post-marketing Surveillance

2 Risk Management principles

3 Advertising & Promotional Regulation

4Supervision on reprocessing of single-use medical devices

Distribution Control

Level of importance

Group 1Group 2

Group 4

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Group 3

3

& The Journey Continues

White PaperCompetency HandbookCurriculumTraining certification