Место проведения: Отель «Хаятт Ридженси Екатеринбург» , ул. Бориса Ельцина, 8
Зал: Бальный зал, 2 этаж (все мероприятия)
Morning moderators: Vladimir Kutichev, Head of medical device software lab, Roszdravnadzor, Russia; Aysylu Valeeva, Deputy Head of Division of organization of state control and registration of medical devices, Roszdravnadzor, Russia
Afternoon moderator: Peter Linders, Philips
Зал: Бальный зал, 2 этаж (все мероприятия)
Регистрация окончена
Понедельник, 16 сентября 2019 г.
Совместный семинар IMDRF/DITTA «Искусственный интеллект в здравоохранении».
Morning moderators: Vladimir Kutichev, Head of medical device software lab, Roszdravnadzor, Russia; Aysylu Valeeva, Deputy Head of Division of organization of state control and registration of medical devices, Roszdravnadzor, Russia
Afternoon moderator: Peter Linders, Philips
No |
Topic |
Speaker |
Scheduled Time |
Welcome coffee and registration |
8:30 – 9:00 | ||
Section 1: Opening Remarks |
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1a | Welcome from IMDRF Chair | Elena Astapenko, Head of Division of organization of state control and registration of medical devices, Roszdravnadzor, Russia | 9:00 – 9:10 |
1b | Welcome from DITTA | Nicole Denjoy, DITTA Chair | 9:10 – 09:20 |
Section 2: AI in Healthcare and regulatory developments (industry and healthcare professionals view)• Introduction into AI;• Concrete examples by industry of AI software in different application areas; • What does AI bring to healthcare from a clinician’s perspective; • Development of AI based software causes both new opportunities as well as new challenges |
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2a | Introduction into AI and its unique characteristics | Robert Phillips, Siemens Healthineers | 9:20 – 9:35 |
2b | What does AI bring to healthcare and AI examples including application in Oncology | Olga Bakhvalova, Philips, Russia | 9:35 – 9:50 |
2c | Prospects for the use of artificial intelligence technologies in the Russian healthcare system | Alexander Gusev, Expert at K-MIS, Member of the Expert Council of the Ministry of Health of the Russian Federation on the use of information and communication technologies in the healthcare system | 9:50 – 10:05 |
2d | Creating an Artificial Intelligence Market for Health service | Boris Zingerman, Head of Digital Medicine Department, Invitro, Russia | 10:05 - 10:20 |
2e | The participation of the Skolkovo Foundation in the development of medical artificial intelligence in Russia. Features of the launch of a Russia-based startup on the global market | Vladimir Egorov, Skolkovo Foundation, Senior Project Manager, Biological and medical technology cluster, Russia | 10:20 – 10:35 |
2f | Panel discussion | Panelists | 10:35 - 10:55 |
Coffee/tee break |
10:55 - 11:15 | ||
Section 3: AI in Healthcare and regulatory developments: possibility and challenges (regulatory view)• Current regulatory practice and Overview of regulatory developments on AI |
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3a | Perspectives and Regulatory Considerations for AI and Big Data in Medical Devices | Seungho Son, Ministry of food and drug safety (MFDS), South Korea | 11:15 - 11:30 |
3b | WHO view for AI | Bernardo MARIANO, Chief Information Officer, World Health Organization *via WebEx | 11:30 – 11:45 |
3с | Regulatory framework on medical devices using AI technology in Russia | Vladimir Kutichev, Head of medical device software lab, Roszdravnadzor, Russia | 12:00 – 12:15 |
3d | The development of policy measures on medical devices using AI technology in Japan | Fumihito Takanashi, Deputy Director Medical Device Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan | 12:15 – 12:30 |
3e | Panel discussion | Panelists | 12:30 - 13:00 |
Lunch break |
13:00 – 14:00 | ||
Section 4: Overview of AI standardization activities• State-of-play of existing initiatives |
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4 | Overview of AI standardization activities. Multiple international standard initiatives regarding AI in healthcare incl. at ISO, IEC and WHO levels. | Pat Baird, Philips *via Webex | 14:00 – 14:30 |
Section 5: Challenges for Healthcare Professionals and patients• Questions of clinical evaluation/evidence/investigation of AI based software• Data quality and availability, protection, interoperability, cybersecurity • Liability • The problem of responsible party determination in the sphere of AI application. Concerns of healthcare professionals as well as software manufacturers |
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5a | Experience of introducing products based on artificial intelligence in the health care of Yamal | Olga Belorus, Director of Medical Information and Analytical Center, YNAO, Salekhard, Russia | 14:30 – 14:45 |
5b | Experience in testing and comparing different solutions based on artificial intelligence for the Moscow health service | Kristina Sergunova, Head of development of control methods and technical monitoring Department of Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Department, Russia | 14:45 – 15:00 |
5c | Preparation and conduct clinical trials for an artificial intelligence-based clinical decision support system | Denis Gavrilov, Chief Karelia Republic Regional Office, Russian Society of Cardiology, Russia | 15:00 – 15:15 |
5d | How industry can cope with challenges? | Philippe Lartigue, GE Healthcare | 15:15 - 15:30 |
5e | Industry responsibility and liability | Pat Baird, Philips *via Webex | 15:30 – 15:45 |
5f | Panel discussion | Panelists | 15:45 – 16:05 |
Coffee/tea break |
16:05 – 16:35 | ||
Section 6: Regulatory challenges - what applies to AI?• Conformity assessment• Change control • Feasibility of creating AI adaptation rules and algorithm change protocol (ACP) • Cybersecurity |
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6a | Introduction to review points for decision-making medical device software using deep learning technology | Peng Liang, Deputy director of division I of Center for Medical Device Evaluation (CMDE), National Medical Products Administration (NMPA), China* *via Webex | 16:35 – 16:50 |
6b | Regulatory challenges for AI – a European RA perspective | Matthias Neumann, Federal Ministry of Health Germany, EU | 16:50 – 17:05 |
6c | Industry overview on regulatory challenges | Naoki Morooka, Shimadzu | 17:05 – 17:20 |
6d | Applying Advanced Technology in Clinical Practice: Regulatory Approval Cases of AI Software | Jungin Lee, Lunit | 17:20 – 17:35 |
6e | Panel discussion | Panelists | 17:35 – 17:50 |
Section 7: Concluding Remarks & Next Steps |
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7 | Conclusions | Moderators | 17:50 – 18:00 |
Повестка семинара IMDRF/DITTA 16 сентября 2019 г., Екатеринбург.
Архив. Повестка семинара IMDRF/DITTA 18 марта 2019 г., Москва.
Вторник, 17 сентября 2019 г. 9.00 – 17.35
Открытый Форум заинтересованных лиц IMDRF-16.
AM Session, 9:00am – 14:00pm |
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8:00 – 9:00 | Welcome Coffee/tea break and registration | |
1 | 9:00 – 9:15 | Welcome speech |
9:00 – 9:05 | Mikhail A. Murashko, Head of Roszdravnadzor | |
9:05 – 9:10 | Nikolay N. Tsukanov, The Russian President’s Plenipotentiary Respresentative in Ural’s Federal District | |
9:10 – 09:15 | Evgeny V. Kuyvashev, Governor of Sverdlovsk region | |
2 | 9:15 – 11:45 | Management Committee Member Regulatory Updates (10 min each + 5 min Q&A) |
9:15 – 9:30 | a. Australia (Speaker: Tracey Duffy) | |
9:30 – 9:45 | b. Brazil (Speaker: Leandro Rodrigues Pereira ) | |
9:45 – 10:00 | c. Canada (Speaker: David Boudreau) | |
10:00 – 10:15 | d. China (Speaker: Yuan Peng) | |
10:15 – 10:30 | e. European Union (Speaker: Erik Hansson) | |
10:30 – 10:45 | f. Japan (Speaker: Fumihito Takanashi) | |
10:45 – 11:00 | g. Russia (Speaker: Elena M. Astapenko ) | |
11:00 – 11:15 | h. Singapore (Speaker: Wong Woei Jiuang) | |
11:15 – 11:30 | i. South Korea (Speaker: Jin-young Yang) | |
11:30 – 11:45 | j. United States (Speaker: Jeffrey Shuren) *Via Webex | |
11:45 – 12:00 | Coffee/tea break | |
3 | 12:00 – 14:00 | Overview of progress to date on the work items (10 min each + 5 min Q&A) |
12:00 – 12:15 | a. Regulated Product Submission (RPS) (Canada, Speaker: Daniel Yoon) | |
12:15 – 12:30 | b. Medical Device Adverse Event Terminology (Japan, Speaker: Mari Shirotani) | |
12:30 – 12:45 | c. Good Regulatory Review Practice (Singapore, Speaker: Rama Sethuraman) | |
12:45 – 13:00 | d. Standards (USA, Speaker: | |
13:00 – 13:15 | e. Personalized Medical Devices (Australia, Speaker: Tracey Duffy) | |
13:15 – 13:30 | f. Medical device clinical evaluation (China, Speaker: Ju Shan) | |
13:30 – 13:45 | g. Medical device cybersecurity (Canada, Speaker: Daniel Yoon) | |
13:45 – 14:00 | h. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (Russia, Speaker: Tatyana Y. Buryakina) | |
14:00 – 15:00 | Lunch break | |
PM Session, 15:00pm – 17:50pm |
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4 | 15:00 – 17:25 | Stakeholder Sessions (10 min each + 5 min Q&A) |
15:00 – 15:15 | a. Russian Ministry of industry and trade (Speaker: Dmitry S. Galkin) | |
15:15 – 15:30 | b. WHO (Official Observer) ( Speaker: Joey Gouws) | |
15:30 – 15:45 | c. APEC (Regional Harmonization Initiative) ( Speaker: Cheng-ning Wu) | |
15:45 – 16:00 | d. AHWP (Regional Harmonization Initiative) ( Speaker: Ali M. Al Dalaan) | |
16:00 – 16:15 | e. PAHO (Regional Harmonization Initiative) ( Speaker: Alexandre Lemgruber) | |
16:15 – 16:30 | f. DITTA (Industry) ( Speaker: Annika Eberstein) | |
16:30 – 16:45 | g. GMTA (Industry) Global Regulatory Convergence (Speaker: Philippe Auclair) | |
16:45 – 17:00 | h. International association of developers, producers and users of medical technique (Industry) (Speaker: Anatoly V. Sludnykh) | |
17:00 – 17:15 | i. IMEDA (Roche Diagnostics) (Speaker: Igor Filippov) | |
17:15 – 17:30 | j. Abbott Laboratories and IMEDA (Speaker: Zaman A Khan) | |
5 | 17:30 – 17:35 | Concluding remarks by IMDRF Chair |
17:35 – 17:50 | Coffee/tea break |
18:30 Sverdlovsk Philharmonic Performance Hosted by Russia
*IMDRF Secretariat reserves the right to make amendments to this Agenda
Архив. Повестка Открытого Форума заинтересованных лиц IMDRF-15, 19 марта 2019 г., Москва