ahwp updateimdrf.org/docs/imdrf/final/meetings/imdrf-meet-170919... · 2017-10-04 · joined in...
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AHWP Update
September, 2017
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Expansion of AHWP Member Economies
2 new countries joined in 2015
4 new countries joined in 2016
1 new application received in 2017
Total of 30 member economies as of Sept, 2017
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AHWP Meetings 2015 2016 2017
TC Leaders Meeting Mar 19-20th in Singapore
20th AHWP Annual Meeting Nov 2-6th in Bangkok
• 241 participants, 28 countries • 11 main themes and 6 panel discussions with 36 speakers • 2 new member economies
TC Leaders Meeting April 27-29th in Seoul
21st AHWP Annual Meeting Nov 21-25th in Cebu
• 300 participants, 40 countries • 12 main themes and 5 panel discussions with 66 speakers • 4 new member economies • 1 new liaison
Upcoming Events
22nd AHWP
Annual Meeting will be held
in Dec 4-8th in New Delhi, India
TC Leaders Meeting March 2-3rd in Hong Kong
• Development of guidance documents with AHWP leaders, advisors and WG members • International conference
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20th Anniversary of AHWP
Celebration Ceremony Certificate of appreciation for all of 30 member economies & 3 liaisons
AHWP Website Renewal work in progress to launch a new official website for easier access and better communication
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AHWP Capacity Building Program
CBP Overview
• Kick-off in Nov 6th, 2015 in Thailand • Overall budget is $50,000 USD
In-Country Training in Indonesia Capacity Building Workshop in Philippines
In-Country Training in Vietnam In-Country Training in Malaysia
• July 28-29th, 2016 • 50 Indonesia regulators • 20 experts from industry • Topics: AHWP’s essential principles of safety and performance and clinical studies
• August 25-26th, 2016 • 50 Vietnam regulators & experts from industry • Topics: classification of medical devices & IVDs, pre-market approval, post-market surveillance
• November 21-22nd, 2016 • 150 international regulators & industrial members • Topics: cybersecurity, GMDN, product dossier for pre-market registration submission, post- market report and review
• August 10th, 2017 • 200 international regulators & experts from industry • Topics: software, information technology, post- market considerations
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AHWP Guidance Documents
2015 2016 2017
12 guidance documents
15 guidance documents
12 guidance documents
Endorsed
Endorsed
Work in progress
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Collaboration with IMDRF
Towards Regulatory
Convergence
Continued attendance in IMDRF meetings
IMDRF MC meeting Stakeholders Forum
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AHWP Global Partnership
• Participation in APEC meetings • AHWP-AHC Joint Workshops • Co-operation of APEC Medical Device Vigilance Roadmap
• Joint efforts to publish an OECD report of “International Regulatory Co-operation: the Role of International Organisations in Fostering Rules of Globalisation • Attending in OECD meeting
• Participation in WHO Global Conferences • AHWP-WHO joint meeting for IVD PQ program
• Participation in PAHO meeting • Inviting PAHO to participate in AHWP meeting • Discussion of collaboration works
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AHWP Activities with Liaisons
• 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
• GS1 training workshop • Participation in AHWP meetings to present on updated works done by GS1
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22nd AHWP Annual Meeting
• Date: Dec 4th- 8th, 2017 • Venue: the Grand New Delhi, India • Program: AHWP annual meeting, AHWP Technical Committee (TC) meeting,
Capacity building workshops, Joint workshops with liaisons, Updates of IMDRF and other international organizations, election
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Thank you