AHWP Update Growing from Strength to Strength Tran Quan AHWP Vice-Chair (Industry) Head of APAC RAGAQA, Align 24 Oct 2018
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
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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
Nu
mbe
r of
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pon
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nts
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
Nu
mb
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f res
pon
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ts
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
Nu
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Group 3
3
& The Journey Continues
White PaperCompetency HandbookCurriculumTraining certification