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.”

20150420-remyelination

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

Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices. 

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

  • Cite the regulatory requirements for recalls/ field actions regarding medical devices
  • Reference and use medical device recall authority and guidance documents
  • Identify and understand the applicable regulatory standards and guidance documents
  • Identify the different recall types and classifications
  • Explain what types of communications are required
  • Define what effectiveness checks are
  • Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA’s handling of MDR reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Effective Technical Writing in the Life Sciences

The tips and abilities exhibited can be connected quickly and will be clear in the absolute first archive that you compose after this virtual course.

In the wake of setting the phase for this substance, we dive into the composition procedure starting with the group of spectators and how the crowd must be dissected to decide the dimension of composing that must be utilized to finish the report.

Social occasion the data to be incorporated into the specialized report requires coordinated effort between the essayist and the different topic specialists that have the learning to be reaped. How that data is accumulated can be a successful productive procedure or an insufficient tedious undertaking all ward upon the strategies utilized to execute the action.

We will address the best systems for removing data from SMEs just as those methods that work best when watching methodology and exercises to be recorded.

Why You have to know

Indeed, even with the approach of innovation, despite everything we speak with the composed word.  Technical composing is tied in with passing on data rapidly, precisely, plainly, and succinctly.  How we impart, how we are comprehended, and how the message is gotten legitimately relies on our aptitudes as specialized writers.  In the existence sciences, this ability is exceedingly significant.

In the existence sciences, a lot is on the line as far as the composition’s capacity to empower 100% precise comprehension of the substance and where appropriate, execution of the undertaking or system documented.  In the existence sciences, that could mean the contrast between crucial, security or damage, misfortune or recuperation, tainting or virtue, achievement or disappointment.

Shockingly, specialized composing isn’t an expertise that is given much accentuation in school educational plans if any.  Technical composing is an ability, life sciences laborers are accepted to have and are relied upon to exhibit at a dimension of aptitude more often than not past the capacity of most.  Unfortunately, most perusers of specialized composing are in the “same boat.”  They “don’t have a clue about a decent one when they see one.” At the day’s end, by and large, you have fair composition, best case scenario that could possibly pass on the message planned.

This virtual workshop will walk you through the specialized composition process from begin to finish.  Each basic part of composing specialized reports for the existence sciences will be tended to with the objective of helping you become better specialized writers.  The tips and abilities exhibited can be connected quickly and will be clear in the absolute first archive that you compose after this virtual course.

  • What is technical writing, and what role does technical writing play in the life sciences?
  • Technical writers in the life sciences – what do they write – types of medium
  • Analyzing the audience
  • Analyzing the information – working with Subject Matter Experts
  • Planning the content
  • Formats, consistency and styles
  • Non-native audience considerations
  • Grammar, spelling, punctuation, numbers and symbols
  • Simplify your writing
  • Ensuring accuracy

By the Instructor Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

Directives on active implantable medical devices (90/385/EEC)

Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

The Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

Medical device Regulation

The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

  • The updated Regulation
  • Implementation dates and transition
  • Main changes and products affected
  • Effect on medical device manufacturers

Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

Upcoming Changes with HIPAA 2019

The entire HIPAA Security Rule and uncover simple methods to comply and create policy.

The entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Do you know all of the requirements of this enigmatic law? Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task Times have changed and new laws are now in place concerning protected health information.

The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive This once rarely enforced law has changed and you need to know what’s going on! Protect your practice or business!

These day’s trial attorney’s pose an even higher risk than the Federal government!

State laws are now in place increasing liability for patient remedies!

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will be discussing 2019 changes taking place in Washington with the Health and Human Services regarding the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the audit process and some current events regarding HIPAA cases (both in courtrooms and from live audits)

Instructor cover all these areas:

  • Study all 18 Standards and 44 Implementation Specifications of the regulations
  • Updates for 2019
  • Requirements of Compliance Officers
  • New definition of what constitutes protected health information
  • Real life litigated cases
  • BYOD
  • Portable devices
  • Business associates and the increased burden
  • Emailing of PHI
  • Texting of PHI
  • Federal Audit Process
  • HIPAA and suing – how this works
  • Risk Assessment
  • Best resources

Want To Step Up Your HIPAA? You Need To Read This First

You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.

Confused about all of the misinformation relating to HIPAA, what you can and can’t do?

Join me in the six-hour virtual seminar and let me get those questions FINALLY answered for you once and for all!

There is unfortunately a lot of confusion about transmissions of protected health information and what we as business associates and covered entities need to do and what we SHOULD NOT do!

Join me in this six-hour virtual seminar as we discuss the do’s and don’ts regarding texting and emailing along with any other sorts of transmissions of protected health information!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, emailing, and transmission in general of protected health information (PHI).

You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.

I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk.
These day’s trial attorney’s pose a higher risk than the Federal government!

I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

I will speak on specific experiences from over 18 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.

More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
Don’t always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

  • Applicable and relevant regulations in EU, Canada and US
  • Definitions
  • Medical device adverse event reporting requirements in EU, Canada and US.
  • Medical device vigilance system during the post-production phase in EU.
  • Mandatory medical device problem reporting requirements in Canada.
  • Mandatory medical device reporting requirements in US.
  • Review of actual reporting forms in EU, Canada and US
  • Applicable and relevant guidance documents
  • Conclusion

Who Will Benefit:

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs

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