Venue: Hyatt Regency Yekaterinburg hotel, 8 Boris Yeltsin Street
Hall: Ballroom, 2nd floor (all meetings)


Registration is closed.



Monday, September 16, 2019.

IMDRF/DITTA joint workshop «Artificial Intelligence in Healthcare»

Artificial Intelligence (AI) in Healthcare is receiving more and more attention. For example, healthcare providers are embedding the technology into their workflows and the decision-making processes. AI is aimed at improving outcomes for patients and other healthcare stakeholders. Uncertainty about regulatory appreciation of AI in Healthcare is leading to a variety of national legislative initiatives, risking serious fragmentation and limitation of exploiting what AI has to offer. We will only get the full benefits of Artificial Intelligence in Healthcare if we appropriately identify and address the key regulatory challenges which will be discussed during the workshop. This workshop provides a unique opportunity to gain a status overview of regulatory and standardization initiatives across the world and to openly discuss possibilities to converge on future regulatory obligations. Still AI is not something to automatically regulate, thus participants will discuss what is applicable, how to apply, or whether we need to adapt existing regulatory frameworks and IMDRF guidance documents. This event will also include a discussion on possibilities of global convergence in the IMDRF context.

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

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
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
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
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
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
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
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

7 Conclusions Moderators 17:50 – 18:00


IMDRF/DITTA workshop agenda 16 September 2019, Yekaterinburg

Archive. IMDRF/DITTA workshop agenda 18 March 2019, Moscow



Tuesday, September 17, 2019. 9.00 – 17.35

IMDRF-16 Open Stakeholder Forum

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AM Session, 9:00am – 14:00pm

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

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

Archive. IMDRF-15 Open Stakeholder Forum Agenda, 19 March 2019, Moscow