The OECD Nuclear Energy Agency (NEA) in collaboration with the Canadian Nuclear Safety Commission (CNSC) hosted an international, multi-sector workshop on 14-18 December 2020 on safely regulating innovative and disruptive technologies.
Recording Multi-sector workshop on innovative regulation - Closing session - YouTube
Regulatory frameworks vary across each sector and from country to country. Each has its own set of stakeholders, safety standards, history, and legal framework. Despite these differences, regulatory frameworks share a common goal: to allow society to reap the benefits of a particular activity or technology (e.g. commercial flights, medical devices) while ensuring that the risks to individuals and society are maintained at an acceptable level. Sharing this strategic goal means that regulators from different sectors and countries can learn from one another by exchanging best practices.
Regulators in non-nuclear sectors have undergone recent changes that can help shape the collective intelligence of the regulatory community. This workshop provided a forum for them to share their experiences in standardisation, design review, licensing and reporting systems, and international co-ordination.
The objective of this workshop was to discuss best practices that the nuclear sector can adopt when licensing innovative technologies including, but not limited to, small modular reactors (SMRs). While many SMR concepts are under development, most involve the concept of modules where the majority of fabrication and construction takes place in a factory. Following assembly, the modules can be shipped anywhere in the world and installed where power is needed. This approach makes standardisation essential and requires a uniform approach to codes and standards. SMR deployment would likely be rendered impractical if each module were to be custom designed and fabricated according to country-specific requirements. Some limited-scope efforts at international co-operation are already underway and this workshop will discuss early observations from those projects.
The workshop brought together regulators and stakeholders, including industry representatives, and international organisations to share information between nuclear and other highly regulated sectors towards harmonised, efficient, and effective regulatory processes in the context of innovation.
The workshop focused on practical examples of how regulators can address two key challenges:
For both challenges, the workshop focused on pragmatic, real world examples rather than hypotheticals. Speakers and panellists from all sectors provided success stories and cautionary tales, according to their experiences.
Day 1 - 14 December 2020 13:00-13:10 (UTC+1) Introductory information and Zoom logistics |
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| Opening session - keynote speakers |
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| 13:10-13:40 |
Mr. William D. MAGWOOD, IV, Director-General of the Nuclear Energy Agency |
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Ms. Rumina VELSHI, President and Chief Executive Officer of the Canadian Nuclear Safety Commission |
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| Session 2 - The nuclear sector innovative regulation process: challenges to serve safety of emerging technologies |
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| 13:40-14:05 |
The concept of a European Reactor Design Acceptance (ERDA) – JODA Mr. William RANVAL, Director of ENISS (European Nuclear Installations Safety Standards) |
25 min. |
| 14:05-15:00 |
Panel and Q&A session lead by moderator Ms. Maria G. KORSNICK, President and Chief Executive Officer, Nuclear Energy Institute, US Mr. Mark FOY, Chief Nuclear Inspector for the Office for Nuclear Regulation in the UK Mr. Ho NIEH, Director, Office of Nuclear Reactor Regulation, US Nuclear Regulatory Commission Mr. Simon IRISH, Chief Executive Officer, Terrestrial Energy Mr. Anton MOSKVIN, Vice President, Marketing & Business Development, Rusatom Overseas, ROSATOM Mr. William RANVAL, Director of ENISS (European Nuclear Installations Safety Standards) Moderator: Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission |
55 min.
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| Day 2 - 15 December 2020 13:00-13:10 (UTC+1) Introductory information and Zoom logistics |
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| Session 3 - Moving safely from aircrafts to drones: licensing disruptive technologies |
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| 13:10-14:00 |
Presentations Ms. Silvia GEHRER, Regional Director, ICAO European and North Atlantic (EUR/NAT) Office, United Nations International Civil Aviation Organisation Ms. Jagoda EGELAND, Advisor to the Secretary-General, International Transport Forum at the OECD |
25 min.
25 min. |
| 14:00-15:00 |
Panel and Q&A session lead by moderator Mr. Christian SCHLEIFER-HEINGÄRTNER, Secretary General, EUROCAE Mr. Simon MOORE, Assistant Secretary, Safety and Future Technology, Australian Department of Infrastructure, Transport, Regional Development & Communications Mr. Vassilis AGOURIDAS, UAM Initiative Leader (EU Smart Cities Marketplace) / Head of EU Public Co-Creation & Ecosystem Outreach (AIRBUS Urban Mobility) Ms. Silvia GEHRER, Regional Director, ICAO European and North Atlantic (EUR/NAT) Office, United Nations International Civil Aviation Organisation Ms. Jagoda EGELAND, Advisor to the Secretary-General, International Transport Forum at the OECD Moderator: Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission |
60 min. |
| Day 3 - 16 December 2020 13:00-13:10 (UTC+1) Introductory information and Zoom logistics |
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| Session 4 - The international licensing system for transportation of nuclear material: a success story and a look to the future |
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| 13:10-14:00 |
Presentations Mr. Stephen WHITTINGHAM, Head of the Transport Safety Unit, United Nations International Atomic Energy Agency Mr. Martin PORTER, Secretary General of the World Nuclear Transport Institute |
25 min. |
| 14:00-15:00 |
Panel and Q&A session lead by moderator Dr. Jean-Christophe NIEL, Director General of Institute for Radiological Protection and Nuclear Safety, France, Chair of the OECD NEA Committee on the Safety of Nuclear Installations Ms. Rebecca TADESSE, Head of Radioactive Waste Management and Decommissioning Division, OECD Nuclear Energy Agency Mr. Serge GORLIN, Head of Industry Cooperation Department at World Nuclear Association (WNA) Ms. Jennifer NUGENT, Head of Technical, and Member of the International Nuclear Services (INS) Executive Team Mr. Stephen WHITTINGHAM, Head of the Transport Safety Unit, United Nations International Atomic Energy Agency Mr. Martin PORTER, Secretary General of the World Nuclear Transport Institute Moderator: Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission |
60 min.
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| Day 4 - 17 December 2020 13:00-13:10 (UTC+1) Introductory information and Zoom logistics |
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| Session 5 - Innovation without borders: challenges and successes of international co-operation on emergent medical technologies |
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| 13:10-14:10 |
Presentations Ms. Adriana VELAZQUEZ BERUMEN, MSc., Biomedical Clinical Engineer, Team Lead Medical Devices and In Vitro Diagnostics, MDD, Health Product Policy and Standards Department, HPS, Access to Medicines and Health Products Division, MHP, World Health Organization Ms. Francesca COLOMBO, Head of the Health Division, Organisation for Economic Co-operation and Development (OECD) Dr. Harald ENZMANN, Chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Head of Section "European and International Affairs" at the German Federal Institute for Drugs and Medical Devices Dr. Carlos PEÑA, Ph.D., M.S., Director, Office of Neurological and Physical Medicine Devices (OHT5), Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health, U.S. Food and Drug Administration |
15 min. 15 min. 15 min. |
| 14:10-15:00 |
Panel and Q&A session lead by moderator Dr. William HEETDERKS, PhD, MD, Consultant to the United States National Institutes of Health, Former Senior Regulatory Official at the United States Food and Drug Administration Dr. Emmanuelle VOISIN, PhD, Founder & CEO, Voisin Consulting Life Sciences Ms. Adriana VELAZQUEZ BERUMEN, MSc., Biomedical Clinical Engineer, Team Lead Medical Devices and In Vitro Diagnostics, MDD, Health Product Policy and Standards Department, HPS, Access to Medicines and Health Products Division, MHP, World Health Organization Ms. Francesca COLOMBO, Head of the Health Division, Organisation for Economic Co-operation and Development (OECD) Dr. Harald ENZMANN, Chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Head of Section "European and International Affairs" at the German Federal Institute for Drugs and Medical Devices Dr. Carlos PEÑA, Ph.D., M.S., Director, Office of Neurological and Physical Medicine Devices (OHT5), Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health, U.S. Food and Drug Administration Moderator: Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission |
50 min. |
| Day 5 - 18 December 2020 13:00-13:05 (UTC+1) Introductory information and Zoom logistics |
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| Session 6: Harmonisation of licensing: beyond regulators and licensees, how do the other stakeholders view the situation? |
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| 13:05-14:45 |
Presentations followed by panel and Q&A session lead by moderator Mr. Bruce CHEW, Federal Research Leader for Deloitte’s Center for Government Insights (DCGI) and Managing Director in Deloitte Consulting’s Government and Public Services (GPS), Deloitte Ms. Kirsty GOGAN, Co-Founder, TerraPraxis, and Managing Partner of LucidCatalyst, Chair of the UK Government’s Nuclear Innovation Research and Advisory Board (NIRAB) Cost Reduction Working Group, and Co-Founder Energy for Humanity (EFH) Ms. Marie-Françoise RENARD-GONDINET, Offshore Sales and Marketing Director & Mr. Denis BOURGUIGNON, Nuclear Development and Technical Manager, BUREAU VERITAS Ms. Kathryn MARTIN, Director, Asia & US, Access Partnership Mr. Jean-Jacques DOREAU, Executive Manager of the Agriculture Insurance Market, ALLIANZ France Moderator: Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission |
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| Session 7 - Recommendations to the nuclear sector, the path forward |
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| 14:45-15:45 |
Panel and Q&A session lead by moderator Mr. Mark FOY, Chief Nuclear Inspector for the Office for Nuclear Regulation in the UK Mr. Christian SCHLEIFER-HEINGÄRTNER, Secretary General, EUROCAE Mr. Jean-Christophe NIEL, Director General of Institute for Radiological Protection and Nuclear Safety, France, Chair of the OECD NEA Committee on the Safety of Nuclear Installations Dr. Harald ENZMANN, Chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Head of Section "European and International Affairs" at the German Federal Institute for Drugs and Medical Devices Mr. Bruce CHEW, Federal Research Leader for Deloitte’s Center for Government Insights (DCGI) and Managing Director in Deloitte Consulting’s Government and Public Services (GPS), Deloitte Mr. Ramzi JAMMAL, Executive Vice President and Chief Regulatory Operations Officer, Canadian Nuclear Safety Commission Moderator: Mr. William D. MAGWOOD, IV, Director-General of the Nuclear Energy Agency |
60 min. |
| Closing session - keynote speakers |
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| 15:45-16:00 |
Mr. William D. MAGWOOD, IV, Director-General of the Nuclear Energy Agency Ms. Rumina VELSHI, President and Chief Executive Officer of the Canadian Nuclear Safety Commission |
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