Reviving cerebrum foundational microorganisms may hold key to future MS medications

Scientists at the University of Cambridge in the United Kingdom found that expanding firmness in the maturing mind hinders the capacity of OPCs.

Researchers have figured out how to make more seasoned cerebrum undifferentiated organisms in rodents progressively young. The disclosure could prompt improved medications for maturing related illnesses that corrupt the mind and sensory system.

The examination concerns oligodendrocyte begetter cells (OPCs), which are a kind of foundational microorganism, or juvenile cell. OPCs are basic for the sound working of the cerebrum and the remainder of the focal sensory system.

OPCs develop, or separate, into oligodendrocytes, which are the phones that produce the myelin sheath that encompasses nerve filaments and jam the electrical sign that they convey.

Annihilation of myelin is a distinctive component of numerous sclerosis (MS), and maturing related changes to OPCs add to the procedure. Maturing can likewise decrease OPC work in sound people.

Scientists at the University of Cambridge in the United Kingdom found that expanding firmness in the maturing mind hinders the capacity of OPCs.

When they transplanted OPCs from more established rodents into the cerebrums of more youthful rodents, the matured OPCs started to capacity like energetic OPCs.

Stiffening of stem cell niche:

The team eventually established that the loss of function in the OPCs was a result of something happening in their microenvironment, or stem cell “niche.”

“Here we show,” write the authors in a recent Nature paper, “that the OPC microenvironment stiffens with age, and that this mechanical change is sufficient to cause age-related loss of function of OPCs.”

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It appears that the stem cell niche reflects the aging-related changes in the “chemical and mechanical signals” that it sends to the OPCs residing in it.

Once the transplanted aged OPCs sensed that they were in a more youthful, soft environment, they began to behave more like vigorous, younger OPCs.

To explore what was going on in more detail, the team ran some laboratory experiments with OPCs and “biological and synthetic scaffolds to mimic the stiffness of young brains.”

‘Molecularly and functionally rejuvenated’

The researchers observed that when they grew aged OPCs on soft material scaffolds, they started to behave more like youthful OPCs.

The aged OPCs were “molecularly and functionally rejuvenated” as a result of being on the softer material.

Conversely, placing young OPCs on scaffolds comprising stiffer material, caused them to behave like older ones.

“We were fascinated,” says co-senior study author Dr. Kevin J. Chalut, “to see that when we grew young, functioning brain stem cells on the stiff material, the cells became dysfunctional and lost their ability to regenerate, and in fact began to function like aged cells.”

Dr. Chalut works in the Department of Physics and the Stem Cell Institute at the University of Cambridge.

He observes, however, that the more interesting finding was seeing the old OPCs growing in the soft material, and how “they began to function like young cells — in other words, they were rejuvenated.”

“This suggests a new way forward to override the age-related loss of function in this important stem cell system,” he adds.

Read more at https://www.medicalnewstoday.com/articles/326066.php

Easy Ways You Can Turn Hipaa Compliant Into Success

The materials will discuss IT security in the context of an overall organization security program including the value and approach of an IT security vulnerability test.

The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is.  It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates.

The second part of the first presentation is an overview of how to manage the HIPAA compliance project.

The second session describes what a Risk Assessment is and how to perform the risk assessment. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment. This encompasses taking the participants through how to do a HIPAA Privacy Risk Assessment, how to do a HIPAA Security Assessment and how to interpret the results, set priorities and develop a plan for addressing the Risk Assessment findings.

The third session takes the participants through how to prepare a set of HIPAA Policies and Procedures. This includes how to reference the HIPAA regulations in preparing the policies and procedures, how to reference the prior HIPAA Risk Assessments and how to prepare the HIPAA training materials.

The fourth session provides the participants with an orientation of the role the IT services in the healthcare organization in addressing the organization’s HIPAA compliance. This encompasses understanding what role IT hardware and software plays in the HIPAA compliance process, what responsibilities IT vendors should have and how to work with vendors. The materials will discuss IT security in the context of an overall organization security program including the value and approach of an IT security vulnerability test.

 

In the last session participants will review what a HIPAA breach is and what to do when a HIPAA breach occurs. This includes determining if a notification occurred, notification requirements and mitigation options.

There will be a wrap up and discussion session providing an opportunity for the participants to discuss specific issues they may have or get direction regarding particular approaches for HIPAA compliance.

The need for HIPAA compliance has evolved since the HIPAA laws were passed in 1996. In addition, as technology has advanced into more use of the internet and web-based hardware and software resources, compliance has also become more difficult and complex.

Now both covered entities (providers of health care services) and their business associates (support vendors) have to implement comparable compliance measures.

Breaches are almost impossible to escape – recent studies show that approximately 90% of covered entities and business associates have had at least one breach of a patient’s protected health information.  And, HIPAA federal penalties can be significant.

Compounding the issue is that almost all states have incorporated the HIPAA regulations, in one form or another, into their state health care privacy laws and/or the courts have accepted the HIPAA regulations as the standard of care for protecting a patient’s health information.

It is important for the health care organization to know what is expected by the regulations.

To satisfy your HIPAA compliance requirements, health care management and staff need to understand the HIPAA privacy and security regulations, understand how to assess your health care organization’s HIPAA compliance status, understand the role of each of the members of your workforce in meeting your compliance requirements and know what to do if there is a breach of your patient health data.

This webinar provides an in-depth review of these subjects and leaves the participant with a solid understanding of what has to be done to be HIPAA compliant.

People who will be benefits from this

  • Health Care Organization Ownership and Senior Management
  • Office Management
  • Business Associates
  • Physicians
  • Ancillary Service Organizations (Pharmacies, Labs, Radiology)
  • HIPAA Compliance Professions
  • Health Care System Vendors

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.

To compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

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GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Analytical and laboratory certification
  • Documentation and maintenance of records
  • Consequences of noncompliance
  • Disqualification and reinstatement

Who will be benefited by this

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development Personnel
  • Regulatory Affairs Personnel
  • Project Managers
  • Manufacturing Managers
  • Validation Engineers
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Auditors

Instructor Joy McElroy With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Best Biostatistics Tips You Will Read This Year

How do you know if you are pressing the right key, let alone performing the best test?

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

biostatistics

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

A guide to practical Risk Management [ISO14971 and IEC62304]

Risk management being a mandatory component of almost any activity in the medical device industry.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

management

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

How the Things Will Change The Way You Approach [Phase I Gmps]

Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

manufacturing

So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance, and Clinical Operations

Auditing Analytical Laboratories for FDA Compliance

The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

what-to-expect-from-an-energy-audit

The second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of laboratories will require different auditor/specialists. We will discuss the pitfalls that auditors can fall into, and what questions laboratories may expect to encounter.

It is necessary for a company to know if an analytical laboratory is capable of operating in compliance with GMP or other regulations. This is especially critical if the laboratory is a quality control laboratory whose test results will be used to support the release of a product to the public or to support and application for permission to market a product.  The failure of a quality control laboratory to comply with regulations can result in the failure of a request for permission to market a product or a forced recall of a marketed product.

In extreme cases a revocation of the permission to market a product may be the result. In any case the inability to conform to regulations will result in a loss of confidence in the ability of the manufacturer to produce a product that meets quality and regulatory requirements, and, in turn, lead to a refusal to purchase a product.

It is critical that the audit of the laboratory be conducted in a professional manner, as a poor audit will waste money and lead to a false confidence in the abilities of the audited laboratory whether it is internal or external to the company.

  • Potential Auditors
  • Supervisors who must initiate Audits
  • Laboratory Supervisors and Workers
  • Quality Assurance and Control Supervisors and Lead Workers
  • Supervisory Management who must select Contractors
  • Managers
  • Directors
  • Vice Presidents who Supervise Quality Assurance
  • Quality Control
  • Regulatory Affairs Groups

Top benefits from this