This document summarizes the various federal laws and regulations governing embryonic stem cell research in the United States. It outlines protections for human subjects, recombinant DNA research, animals in research, and clinical research using cell lines or differentiated tissue. Regulations cover areas such as informed consent, institutional review boards, good laboratory practices, animal welfare, tissue practices, and xenotransplantation. Non-federal sources of oversight may also apply.
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
Preparing for Increased FDA Enforcement Activities Impacting Clinical StudiesMichael Swit
Presentation covers:
Understanding the Warning Letter in FDA’s Enforcement Arsenal
GCP Warning Letters – Highlights of 2010 and 2011
How to Respond if Targeted
Consequences of Non-Compliance
Lessons Learned
Appendices – Details on Warning Letter observations by type of citation/type of recipient
Assessing oral drug absorption and metabolism in human intestinal tissuesBiopta Inc.
Presentation from "Addressing Biological Barriers" Conference organised by Molecular Profiles on 22 Jan 2014 in Nottingham, UK. Fresh functional human tissues are increasingly recognised as an effective way to model oral drug absorption and metabolism; Biopta is a contract research organisation that offers services in DMPK.
Information explaining what is a clinical trial and what it means to participate in one. Ins and outs, pros and cons of taking part in a clinical trial.
Regulation of KDM5 by multiple cofactors regulates cancer and stem cellsChristopher Wynder
Presentation of data regarding proteins that regulate the activity of KDM5b.
The studies use multiple disciplines including in vitro enzymology, ES cell studies of differentiation, Mass spectrometry to detect protein protein interactions.
These studies resulted in a comprehensive view of KDM5b function. It required development of at least three novel assays that are focused on moving epigenetic research from yeast and HeLa cell types to primary, clinically relevant cell types.
The techniques have been successfully used in Embryonic stem cells (human and mouse), Neural stem cells (mouse and patient derived as well as iPSCs.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
Preparing for Increased FDA Enforcement Activities Impacting Clinical StudiesMichael Swit
Presentation covers:
Understanding the Warning Letter in FDA’s Enforcement Arsenal
GCP Warning Letters – Highlights of 2010 and 2011
How to Respond if Targeted
Consequences of Non-Compliance
Lessons Learned
Appendices – Details on Warning Letter observations by type of citation/type of recipient
Assessing oral drug absorption and metabolism in human intestinal tissuesBiopta Inc.
Presentation from "Addressing Biological Barriers" Conference organised by Molecular Profiles on 22 Jan 2014 in Nottingham, UK. Fresh functional human tissues are increasingly recognised as an effective way to model oral drug absorption and metabolism; Biopta is a contract research organisation that offers services in DMPK.
Information explaining what is a clinical trial and what it means to participate in one. Ins and outs, pros and cons of taking part in a clinical trial.
Regulation of KDM5 by multiple cofactors regulates cancer and stem cellsChristopher Wynder
Presentation of data regarding proteins that regulate the activity of KDM5b.
The studies use multiple disciplines including in vitro enzymology, ES cell studies of differentiation, Mass spectrometry to detect protein protein interactions.
These studies resulted in a comprehensive view of KDM5b function. It required development of at least three novel assays that are focused on moving epigenetic research from yeast and HeLa cell types to primary, clinically relevant cell types.
The techniques have been successfully used in Embryonic stem cells (human and mouse), Neural stem cells (mouse and patient derived as well as iPSCs.
Kara Millonzi of the UNC School of Government provides an overview of county funding responsibilities for public schools as part of a workshop held Aug. 23, 2013, at the NCACC's 106th Annual Conference.
Mesenchymal and epithelial differentiation ability of corneal stem cellsPeyman Ghoraishizadeh
: The corneal stroma is being increasingly recognized as a repository for stem cells. Like the limbal and endothelial niches, stromal stem cells often reside in the peripheral cornea and limbus. These peripheral and limbal corneal stromal cells (PLCSCs) are known to produce mesenchymal stem cells in vitro. Recently, a common corneal stromal and epithelial progenitor was hinted at. This study aims to examine the stem cell potential of corneal stromal cells and to investigate their epithelial transdifferentiation ability
Induced Pluripotent Stem Cell & Cell Dedifferentiation: The Breakthrough of S...Vincentsia Vienna
The phenomenon of cell dedifferentiation is yet one promising trend to explore. In future, the science fiction of regenerative medicine could be turned into reality.
Fresh Tissue for Research in CaliforniaIBio Specimen
Discover the comprehensive capabilities of iBioSpecimen’s Fresh Tissue for Research in California. Our extensive global network seamlessly connects you to a vast array of high-quality fresh tissue samples sourced from hundreds of suppliers worldwide. This unparalleled diversity in both samples and patient origins aligns perfectly with the multifaceted demands of contemporary research.
The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings
January 26, 2018
In the United States, two major federal laws apply to vertebrate animals used in laboratory research. The first of these two statutes, the Animal Welfare Act (AWA, under the US Department of Agriculture), celebrated its fiftieth anniversary in 2016. The second statute, the Health Research Extension Act of 1985 (also referred to as the Public Health Services Act, or PHS Act), which is similar to the AWA, applies specifically to work funded by the US Public Health Service (i.e., agencies under the Department of Health and Human Services). Understanding laboratory animal law is necessary and fundamental for all researchers relying on results from animal research, laboratory animal veterinarians, institutional officials, Institutional Animal Care and Use Committee (IACUC) members and veterinarians in training. They require familiarity with both the scope and particulars of these laws. Different parties interested in or impacted by laboratory animal laws can have significantly different perspectives about the scope or efficiency of the regulations or their implementation.
The Roundtable on Science and Welfare in Laboratory Animal Use of the Institute for Laboratory Animal Research, the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and the Animal Law and Policy Program of Harvard Law School convened this pre-workshop webcast and a workshop to discuss the future of federal laboratory animal law in the United States.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/future-directions-for-laboratory-animal-law-in-the-united-states
View slides from Nathan Herschler's presentation at the ILAR/Harvard Animal Law Roundtable on January 26th, 2018. His presentation addresses significant and potential legal conflicts related to animals in laboratories in the coming years.
Human Subject Protection in Clinical ResearchClinosolIndia
Human subject protection in clinical research is an essential aspect of ensuring that research is conducted in an ethical and responsible manner. It involves the implementation of policies and procedures to protect the rights, safety, and welfare of human subjects who participate in clinical research studies. Here are some key aspects of human subject protection in clinical research:
Informed Consent: Informed consent is the cornerstone of human subject protection in clinical research. It involves providing potential participants with clear and understandable information about the study's purpose, procedures, risks, and benefits, and obtaining their voluntary agreement to participate.
Ethics Review: Clinical research studies involving human subjects must be reviewed by an independent ethics committee or institutional review board (IRB) to ensure that the study design and procedures are ethical, and the potential risks and benefits of the study are carefully evaluated.
Safety Monitoring: The safety and well-being of human subjects must be monitored throughout the study to ensure that any adverse events or unexpected outcomes are promptly identified, reported, and addressed.
Confidentiality and Privacy: Participants' personal information must be kept confidential and protected from unauthorized disclosure. Researchers must take appropriate measures to ensure that the data is secure and used only for the purposes outlined in the research protocol.
Risk Minimization: Researchers have an ethical responsibility to minimize the risks of harm to human subjects by designing studies that are safe and feasible, using appropriate study procedures and interventions, and providing appropriate medical care and follow-up.
Vulnerable Populations: Special considerations must be given to vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive impairments or mental illness. Additional safeguards must be in place to protect their rights and welfare.
Regulatory Compliance: Researchers must comply with relevant laws and regulations governing clinical research, including obtaining regulatory approvals, conducting studies according to Good Clinical Practice (GCP) guidelines, and reporting adverse events or unexpected outcomes.
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Le nuove frontiere dell'AI nell'RPA con UiPath Autopilot™UiPathCommunity
In questo evento online gratuito, organizzato dalla Community Italiana di UiPath, potrai esplorare le nuove funzionalità di Autopilot, il tool che integra l'Intelligenza Artificiale nei processi di sviluppo e utilizzo delle Automazioni.
📕 Vedremo insieme alcuni esempi dell'utilizzo di Autopilot in diversi tool della Suite UiPath:
Autopilot per Studio Web
Autopilot per Studio
Autopilot per Apps
Clipboard AI
GenAI applicata alla Document Understanding
👨🏫👨💻 Speakers:
Stefano Negro, UiPath MVPx3, RPA Tech Lead @ BSP Consultant
Flavio Martinelli, UiPath MVP 2023, Technical Account Manager @UiPath
Andrei Tasca, RPA Solutions Team Lead @NTT Data
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Securing your Kubernetes cluster_ a step-by-step guide to success !KatiaHIMEUR1
Today, after several years of existence, an extremely active community and an ultra-dynamic ecosystem, Kubernetes has established itself as the de facto standard in container orchestration. Thanks to a wide range of managed services, it has never been so easy to set up a ready-to-use Kubernetes cluster.
However, this ease of use means that the subject of security in Kubernetes is often left for later, or even neglected. This exposes companies to significant risks.
In this talk, I'll show you step-by-step how to secure your Kubernetes cluster for greater peace of mind and reliability.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
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