Artificiële Intelligentie & Recht
Innovation, Quantum-AI Technology & Law

Blog over Kunstmatige Intelligentie, Quantum, Deep Learning, Blockchain en Big Data Law

Blog over juridische, sociale, ethische en policy aspecten van Kunstmatige Intelligentie, Quantum Computing, Sensing & Communication, Augmented Reality en Robotica, Big Data Wetgeving en Machine Learning Regelgeving. Kennisartikelen inzake de EU AI Act, de Data Governance Act, cloud computing, algoritmes, privacy, virtual reality, blockchain, robotlaw, smart contracts, informatierecht, ICT contracten, online platforms, apps en tools. Europese regels, auteursrecht, chipsrecht, databankrechten en juridische diensten AI recht.

Berichten met de tag Healthcare
Mauritz Kop Fellow at Inter-CeBIL Harvard Cambridge Copenhagen
Mauritz Kop Fellow at Inter-CeBIL Harvard Cambridge Copenhagen

Harvard-Cambridge-Copenhagen, Sept 15, 2023 — Mauritz Kop has accepted a position as an Inter-CeBIL Fellow at the prestigious Novo Nordisk Foundation Copenhagen-Cambridge-Harvard Inter-CeBIL Programme for International Collaborative Bioscience Innovation & Law. In this role, Kop will focus his research on Advanced Medical Computing, Artificial Intelligence (AI) and Quantum Technologies within the life sciences ecosystem.

About the Inter-CeBIL Programme

The Inter-CeBIL Programme is a world-leading research hub dedicated to identifying and tackling the most significant legal and regulatory barriers to health and life science innovation. The initiative fosters robust knowledge networks to provide tailored legal and regulatory support to patients, researchers, businesses, and incubators, with the ultimate goal of ensuring that health and life science innovations can safely and effectively reach patients and markets.

This international collaboration brings together top-tier academic institutions to drive progress in healthcare and biotechnology. The program is a joint effort between the Centre for Advanced Studies in Bioscience Innovation Law (CeBIL) at the University of Copenhagen, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the University of Cambridge, among other key partners. The program is led by a distinguished team, including Professor Timo Minssen as the Founding Director of CeBIL at the University of Copenhagen, Professor I. Glenn Cohen who leads Harvard Law School’s contribution, and Professor Mateo Aboy who leads the Cambridge part.

Key Research Areas

The Inter-CeBIL Programme centers its research on three key "grand challenges":

1. Advanced Medical Computing: Focusing on Artificial Intelligence (AI) and Quantum Technologies (QT).

2. Pandemic Preparedness & Anti-Microbial Resistance (AMR).

3. Sustainable Innovation & Biosolutions: Encompassing eco-systems, drug R&D, drug regulation, and data infrastructures.

Focus on Key Area 1: Advanced Medical Computing, AI & Quantum Technology

This key research area addresses the increasingly critical role of advanced computing in the life sciences and medical sectors. Algorithms are becoming fundamental building blocks in a wide range of medical devices, digital health technologies (DHTs), and drug discovery tools (DDTs). The use of advanced computing, including AI/ML and quantum computing (QC), holds immense potential benefits for the life sciences, drug discovery, and medical sectors. These advancements also raise significant legal, ethical, governance, and regulatory issues that the program aims to address.

In his capacity as an Inter-CeBIL Fellow, Mauritz Kop will contribute his deep expertise in quantum-AI, its governance, and its legal-ethical implications to this key research area, helping to navigate the complex challenges and opportunities presented by these cutting-edge technologies.

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Academics, Healthcare, Stanford RQT, University, Quantum-AI, Quantum Technology, Quantum ComputingMauritz KopInter-CeBIL, University of Copenhagen, Harvard Law School, Cambridge University, Fellowship, Quantum-AI, Medicine, Healthcare, Governance, Regulation, Law, Ethics, Policy, Mauritz Kop
Safeguards for accelerated market authorization of vaccines in Europe
Safeguards for accelerated market authorization of vaccines in Europe

by Suzan Slijpen & Mauritz Kop

This article has been published by the Stanford Law School ‘Center for Law and the Biosciences’, Stanford University, 15 March 2021. link to the full text: https://law.stanford.edu/2021/03/15/safeguards-for-accelerated-market-authorization-of-vaccines-in-europe/

Download the article here: Slijpen_Kop_Manufacturing Licenses and Market Authorization Vaccines EU-Stanford Law

The first COVID-19 vaccines have been approved

People around the globe are concerned about safety issues encircling the accelerated introduction of corona vaccines. In this article, we discuss the regulatory safeguards for fast-track market authorization of vaccines in Europe. In addition, we explain how the transmission of European Union law into national Member State legislation works. We then clarify what happens before a drug can be introduced into the European market. We conclude that governments should build bridges of mutual understanding between communities and increase trust in the safety of authorized vaccines across all population groups, using the right messengers.

Drug development normally takes several years

Drug development normally takes several years. The fact that it has been a few months now seems ridiculously short. How is the quality and integrity of the vaccine ensured? That people - on both sides of the Atlantic - are concerned about this is entirely understandable. How does one prevent citizens from being harmed by vaccines and medicines that do not work for everyone, because the admission procedures have been simplified too much?

The purpose of this article is to shed a little light upon the accelerated market authorization procedures on the European continent, with a focus on the situation in the Netherlands.

How a vaccine is introduced into the market

In June 2020, the Dutch government, in close cooperation with Germany, France and Italy, formed a Joint Negotiation Team which, under the watchful eye of the European Commission, has been negotiating with vaccine developers. Its objective: to conclude agreements with drug manufacturers at an early stage about the availability of vaccines for European countries. In case these manufacturers are to succeed in developing a successful vaccine for which the so-called Market Authorization (MA) is granted by EMA or CBG, this could lead to the availability of about 50 million vaccines (for the Netherlands alone).

Who is allowed to produce these vaccines?

Who is allowed to produce these vaccines? The Dutch Medicines Act is very clear about this. Only "market authorization holders" are allowed to manufacture medicines, including vaccines. These are parties that have gone through an extensive application procedure, who demonstrably have a solid pharmaceutical quality management system in place and have obtained a pharmaceutical manufacturing license (the MIA, short for Manufacturing and Importation Authorisation). This license is granted after assessment by the Health and Youth Care Inspectorate of the Ministry of Health, Welfare & Sport (IGJ) – by Farmatec. Farmatec is part of the CIBG, an implementing body of the Ministry of Health, Welfare and Sport (VWS). The M-license is mandatory for parties who prepare, or import medicines.

Read more at the Stanford Center for Law and the Biosciences!

Read more on manufacturing licenses, fast track procedures and market authorization by the European Medicines Agency (EMA) and the EC, harmonisation and unification of EU law, CE-markings, antigenic testing kits, mutations, reinfection, multivalent vaccines, mucosal immunity, Good Manufacturing Practices (GMP), pharmacovigilance, the HERA Incubator, clinical trials, compulsory vaccination regimes and continuous quality control at Stanford!

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Ethics, European Law, Farmaceutica, Healthcare, Grondrechten, Innovation, Licenties, Medicine, Medische Producten, Stanford, VaccinsMauritz KopAIRechtVaccines, Corona, COVID-19, SARS-CoV-2, Medication, Law and Biosciences, Stanford Law School, Suzan Slijpen, Mauritz Kop, Stanford University, Marked Authorization, RIVM, Europe, USA, Pharmaceutical Manufacturing License, Dutch Medicines Act, Slijpen Legal, AIRecht, CIBG, Farmatec, EudraGMDP, IGJ, CBG, EMA, FDA, Warp Speed, EUA, fast-track, herd immunity, CHMP, GMP, quality management system, pharmacovigilance, Healthcare, Intellectual Property, Artificial Intelligence, clinical trials, innovation, democracy, ethics, fundamental rights, technology transfer, HERA Incubator, harmonisation, unification, reception, EU law, compulsory vaccination regimes, multivalent vaccines, CE-marking, mutations, reinfection, antigenic testing kits, nasal spray, mucosal immunity
Suzan Slijpen Conference Speaker at the National University of Ireland
Suzan Slijpen Conference Speaker at the National University of Ireland

Legal Aspects of AI in Healthcare

On 16 August 2019, Suzan Slijpen LL.M. had the honour to speak about the legal aspects of the development and use of artificial intelligence (a disruptive technology) in healthcare, at the AI in Medicine Conference organized by the Irish Association of Physicists in Medicine (IAPM). The conference took place in Galway, at the National University of Ireland (School of Physics, NUI Galway/ OÉ Gaillimh). Suzan is a senior legal consultant at AIRecht.nl, and specializes in eHealth & medical devices, pharmaceutical law, European food law and contract law, from an AI helicopterview. She is also founder and lawyer at boutique law office Slijpen Legal.

Key topics of the Artificial Intelligence in Medicine lecture

Key legal topics that Suzan addressed in her Artificial Intelligence in Medicine lecture:

1. AI & Robotics: Disruptive Technologies: Synergetic effects of 4th Industrial Revolution technologies like robotics, big data, quantum computing, Blockchain, Virtual Reality (VR) and Internet of Things (IoT).

2. eHealth and medical devices: legal classification.

3. Fundamental Rights: Safeguarding of Fundamental Rights in AI applications, Rights of Patients.

4. Ethics and responsible AI: 1791 French Revolution Values, HLEG Concept of Trustworthy AI.

5. Intellectual Property on AI and Health Apps: Licensing your IP.

6. Liability for damages caused by smart robots: who is liable for misdiagnosis by an AI algorithm?

7. Legislation and Jurisprudence.

8. AI Impact Assessment: remove roadblocks for AI.

Legislation and regulations regarding AI in Healthcare

Do you want to know more about legislation and regulations regarding AI in Healthcare, or Legal aspects of disruptive tech in Medicine? Or do you want to organize a workshop or conference yourself and invite us as a speaker or teacher? Then please contact us about the possibilities!

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