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Do human factors matter in medical devices?

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes to another equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. It is because of these factors that human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on human factors in medical devices

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices? This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.

 

 

 

Featured

Knowledge of employment laws is absolutely crucial for organizations

support for protection of the domestic workforce will mean to employment laws

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.

One thing that is certain is that 2017 is going to be an uncertain year for employment law. Changes that could make a big difference to many organizations can be expected to be rolled out by the new administration. A fact of additional significance to employers is that there has been a steady increase in the number of employment lawsuits of late.

In 2016, enforcement actions by the Equal Employment Opportunity Commission (EEOC) gave the agency a staggering amount of between $350 and $400 million in monetary damages. This has been the highest recovery ever from the time it was created in 1965. Not surprisingly, the number of claims filed by employees with this Commission has reached record levels in the last three years.

Lack of knowledge of the law is at the root of lawsuits

Most of these lawsuits are a result of the lack of understanding that employers have of workplace issues. Companies in which the managements are ignorant about these issues or choose to overlook them end up facing a host of issues such as:

o  Discrimination suits

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Litigation

o  Lawyer fees

o  Low morale on the part of employees

o  A bad beating to their image.

The means to avoiding such scenarios is for organizations to grasp the enormity of these actions. If they have to avoid litigation and other reputation-damaging actions; they need to be aware of the employment law regulations and be compliant with these. They also need to be clear in their understanding of what to expect from the new administration.

A session to help get thorough understanding of employment laws

It is to impart understanding of these topics that a GlobalCompliancePanel, a leading global name in the field of regulatory compliance trainings, will be organizing a two-day seminar. Vanessa G. Nelson, who is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, maximize human capital, create great teams, and reduce costs, will be the Director of this course.

To get complete understanding of all the crucial aspects of human resource law, the ways by which to comply with employment laws and regulations and the potential impact on employment law from the actions of the new administration; please register for this seminar by visiting Knowledge of employment laws is absolutely crucial for organizations .

A clear roadmap to advanced human resources and employment law

The essence of this seminar is the roadmap to advanced human resources and employment law that Vanessa will lay out for the participants. Given the factors described above; this understanding is critical, no matter what the size of the organization. The right grasp of employment laws and HR practices is essential if organizations have to become successful at their business. The Director of this seminar will simplify the complex nature and the huge number and variety of employment laws and the issues relating to them.

Participants will able to learn the ways of dealing with often muddling human resource situations and how to apply relevant employment laws correctly to avoid problems. A look at the cost of litigation will perhaps give some idea about the need for employers to remain compliant with the employment laws: Without lawyer fees, a lawsuit costs $165,000 on average. The cost of a case that goes to trial is exorbitant: It is in excess of a million dollars, and comes with the strong prospect of imprisonment for noncompliance with employment.

What are the FDA’s Process Validation requirements?

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Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation. Starting from 1987, the FDA has been issuing guidelines at intervals to state, improve and strengthen the general principles of Process Validation. In almost a quarter century of the first guideline, the revision of January 2011 came into being. This guideline is considered a landmark and a guide for PV professionals since it reworked extensively and expanded the general principles on process validation. It is the current guideline from the FDA on Process Validation requirements.

These are what the FDA’s 2011 guideline on general principles on Process Validation propagate:

  • Incorporation of the principles of sound science
  • Taking steps to assess and mitigate risk
  • Bringing about improvements in every stage of the process
  • Adapting the science-based principles of contemporary manufacturing
  • Fostering and encouraging innovation

The centrality of control to process validation

Process validation is tied to the product lifecycle approach by the FDA general principles on process validation of 2011. The central purpose of process validation is to ensure that the process is in a state of control at all stages of production.

The following points illustrate the reason for which the FDA expects its PV requirements to be met:

  • Being a process that is ongoing and continuous, PV begins at the earliest stages of production and goes on till the product’s lifecycle is completed
  • Those in charge of commercial production should have deep and intimate knowledge of the workings of PV principles
  • Only this knowledge helps PV professional locate the sources of variability and address them
  • Only PV into which risk management is built frees errors from the product

The three stages of PV

The FDA stipulates three layers or stages on which its general principles of Process Validation are built:

  • Process design: The stage in which the knowledge gained helps the commercial process define the process development activities
  • Process qualification: The stage where PV guarantees that the process design has the capability for being reproduced at industrial level
  • Continued Process Validation: The most important stage PV in that this is where the element of control into the routine production process is introduced and built; Continued Process Validation takes under its ambit all activities such as continuous verification, maintenance, and process improvement. Information is collected and monitored during commercialization to assess the Continued Process Validation stage.

Screen-free coding for kids : mTiny robot review

They do not want to watch their mother botch sandwich making because of their bad directions.

My five- and seven-year-old constantly fight over who gets the iPad first. We have one, and they get to use it in tiny doses, usually when I’m at my wit’s end. Their favorite app? ScratchJr, MIT’s go-to coding tool for kids. They like to code. No. They love to code, like the good little 21st-century humanoids they are.

They love coding so much and I am so unwilling to give them their own devices that I decided to try something new. It’s also something that sounds so counterintuitive it actually might work: screen-free coding.

With the latest studies presenting a pretty damning picture of screen time’s effects on children’s development, I’m delighted to hear that screen-free coding is all the rage now. It is exactly what it sounds like: a way to explore the key concepts of coding sans screen. At its core, coding is simply giving a set of specific directions to someone or something to produce a desired result. Nothing in that definition demands a screen.

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It is about computational thinking though and the ability to identify and solve problems by breaking the problem and solution into workable chunks. You could teach your kid computational-thinking strategies by asking them to tell you how to make a peanut butter sandwich and it meets the screen-free requirement.

While my kids may want to consume peanut butter sandwiches while they code, hearing that they’re “coding” by telling me how to make them wouldn’t go over well. They want to turn ScratchJr purple and make him curse and jump. They want some form of pixels and plastic to beep and whir and zing. They do not want to watch their mother botch sandwich making because of their bad directions.

Enter mTiny, Makeblock’s cube-shaped robot for the preschool set. It’s cute. It’s fun. It talks. It twirls and giggles and sings. It’s screen-free but uses the same graphics found in ScratchJr in the form of coded cards.

In addition to the USB-rechargeable mTiny robot — with cute panda ears and tail — the kit comes with 36 coding-instruction cards, which are essentially cardboard versions of the ScratchJr graphics. To build codable scenes for mTiny to navigate, Makeblock includes 24 themed, reversible map blocks that kids put together like jigsaw pieces.

More read via https://www.engadget.com/2019/11/17/mtiny-screen-free-coding-robot-review-stem-toy/

How Artificial Intelligence is transforming logistics sector

The Logistics sector has always been one of the most growing sectors and a laggard in the adoption of technology.

The Logistics sector has always been one of the most growing sectors and a laggard in the adoption of technology. But the advent of latest technologies like IoT, Artificial Intelligence (AI), and Machine Learning (ML) have set this sector on a path, which is soon going to not just transform the sector but also will give rise to a whole new breed of paradigms. Now, as the demand for logistics companies is growing, the driver’s safety has become a primary concern.

With the apps like fleet management system (FMS), it is possible to observe driver’s behaviour in real-time and make a training plan which can also solve the issue of employee’s long driving hours and breaks between drives with fully automated fleets. The availability of sensors and Bluetooth wireless technologies in the trucks have made it easier to add trucks to this burgeoning online network of supply chain data, providing last-mile visibility that was previously unattainable.

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Logistics companies are using GPS systems and AI to track the location of their trucks, they can now set up geofences to enable alerts when a truck is nearing its destination, danger, optimise routes using real-time traffic data, improve vehicle utilisation, and automatically track driver hours and fuel tax reporting information. A user-generated input via smartphones is sent onto the drivers which helps them to know the route around construction or congested areas. So that they can avoid these routes and take an alternative route.

Firms have started using this technology for Fuel optimisation, Operational Planning & allocation based on Geospatial & status data, dynamic route management and control. In situations like human errors, traffic or accidents, AI predicts decisions based on data analysis and help to avoid accidents and maintain their safety.

Full Post you can read Via https://www.financialexpress.com/industry/technology/how-artificial-intelligence-is-transforming-logistics-sector/1765595/

Growth and Forecasting for next Upcoming Year Until 2025

Trending factors that will influence the progress of the Global Artificial Intelligence in Diabetes Management Market.

Artificial Intelligence in Diabetes Management Market 2019 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. The Market report offers noteworthy data regarding industry’s growth parameters, the current state of the market in terms of analysis of possible economic situations and macroeconomic analysis. This report features competitive scenarios from the recent technology and provides a comprehensive analysis of key growth strategies adopted by key players.

The report has been accumulated through meticulous primary and secondary research, which encompasses interviews, inspections, and observations of experienced analysts, as well as proven paid sources, news articles, annual reports, trade journals, and company body databases. The study also presents a qualitative and quantitative evaluation by analyzing the data collected from industry professionals and market participants across crucial factors in the industry’s value chain. These segments are studied in detail for the market estimates and forecasts at regional and country level.

This report focuses on the Artificial Intelligence in Diabetes Management Market outlook, future outlook, growth opportunities and core and core contacts. The purpose of the study is to present market developments in the US, Europe and other countries. It also analyzes industrial development trends and marketing channels. Industry analysis was conducted to investigate the impact of various factors and to understand the overall appeal of the industry.

Reasons for buying this report:

  • It offers an analysis of changing competitive scenario.
  • For making informed decisions in the businesses, it offers analytical data with strategic planning methodologies.
  • It offers a seven-year assessment of the Global Artificial Intelligence in Diabetes Management Market.
  • It helps in understanding the major key product segments.
  • Researchers throw light on the dynamics of the market such as drivers, restraints, trends, and opportunities.
  • It offers a regional analysis of the Global Artificial Intelligence in Diabetes Management Market along with the business profiles of several stakeholders.
  • It offers massive data about trending factors that will influence the progress of the Global Artificial Intelligence in Diabetes Management Market.

A detailed outline of the Global Artificial Intelligence in Diabetes Management Market includes a comprehensive analysis of different verticals of businesses. North America, Latin America, Asia-Pacific, Africa, and Europe have been considered for the studies on the basis of several terminologies.

To know more https://tinyurl.com/ye572xqv

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The main reason for which many companies were reluctant to adapt the technology.

The FDA has set out requirements for validating all computer systems that handle data regulated by it. These should be in accordance with its guidance on computerized systems, first issued in 1983. The main points of this guidance continue to be consistent today, even with all the changes that technological developments have brought in.

The 1990’s was a decade in which this guidance was revisited for its relevance to the medical device industry. This was because the first issuance was limited to pharmaceuticals.  In 1997, in the context of the move of many FDA-regulated organizations to move into a paperless environment, the FDA issued 21 CFR Part 11, which sought to address electronic records and signatures.

A few changes, such as discretionary enforcement measures, have been brought into this guidance from then, to fashion it to the needs of the industry. Yet, this issuance is rather confusing, although it was intended to help the industry avoid creating a huge regulatory compliance cost, which was the main reason for which many companies were reluctant to adapt the technology.

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What are the current trends in compliance and FDA enforcement?  Technology is a major basis for these trends, although there are other that are based on economics, social media, new diseases, politics, and many other influences.

All these will be discussed in detail at a six-hour learning session from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.  Carolyn Troiano, a senior compliance professional who has worked in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the expert at this webinar, which is being organized on October 28.

Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-trends-for-computer-system-validation-(csv)-compliance-and-enforcement-10310LIVE to enroll for this valuable learning.

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Everything that is required to protect the validity of data that is regulated by the FDA and is stored in electronic format in computer systems will be explained at this webinar. The expert will describe the ways by which to properly validate an FDA-regulated computer system so that security is ensured and data integrity objectives are met.

It is accepted that implementation and adaptation of the System Development Life Cycle (SDLC) methodology is the ideal approach for Computer System Validation (CSV) and for maintaining the system in a validated state throughout its life. Carolyn will explain this aspect in detail at this webinar.

She will also discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The following areas will be explained at this webinar:

Session 1 (90 Mins):

  • FDA Regulatory Oversight
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology

Session 2 (90 Mins):

  • GAMP 5 Software Categorization
  • System Risk Assessment

Session 3 (90 Mins):

  • Requirements
  • Design
  • Testing
  • Requirements Traceability Matrix (RTM)
  • Additional Validation Documentation

Session 4 (90 Mins):

  • FDA Inspection Trends
  • Regulatory Influences
  • Response to Change

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About the speaker: During the over 35 years she has served in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, Carolyn Troiano has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and also collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Medical Device Recalls – How to Handle in a Compliant, Diligent Manner

How to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

A Medical Device Recall (MDR) can be a handful to deal with. It not only indicates that the device has a quality issue; failing to address an MDR rightly can lead to loss of reputation, not to speak of regulatory penal actions from the FDA. It is up to the company whose device has been recalled, to take prompt, prescribed action. Its actions should be proportionate to the level of risk the faulty device poses.

An MDR should be planned well in advance, for it is not something that a medical device can handle hastily, in a piecemeal fashion. The ways by which to prepare for an MDR is thus a matter of crucial importance. GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will offer this valuable learning at a six-hour webinar it is organizing on October 28.

microchip

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session. To enroll for this webinar, please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-medical-device-recalls—how-to-handle-in-a-compliant,-diligent-manner-10304LIVE

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Even a high degree of preparation by a medical device company cannot completely rule out quality issues that result in a recall. There is no substitute for preparation. The objective of this webinar is to offer learning to its participants on how to prepare for an MDR. Susanne will explain how to decipher signals that could trigger a recall. She will also explain how to face the investigation and what actions are required, what corrective and preventive actions need to be taken, and how to send out notifications to customers and the regulatory bodies.

The expert will give a thorough understanding of the regulatory requirements for dealing with an MDR. She will help understand FDA expectations and regulations, and what to understand and learn from 483s and Warning Letters. The ways of putting robust processes, the basis to efficiently and effectively managing failure investigations, will be explained.

This webinar will also give a proper understanding of recalls, and explain the appropriate corrective and preventive actions that need to be taken. The ways in which these processes link to other aspects of the Quality Management System will be explained. It will give an idea of the best practices for making an MDR efficient. This will help participants prepare for a possible post-recall FDA inspection.

This webinar will have the following agenda:

  • Regulatory Expectations
  • Medical device authority and guidance
  • Complaint Handling, Medical Device Reporting, and Recall requirements
  • Recall Types and Classifications
  • Failure Investigation
  • Difference between a product enhancement and a recall
  • Roles and responsibilities
  • Non-conforming material control
  • Recall strategy and FDA notification
  • Required Communications
  • Firm’s MDR reporting and FDA’s handling of MDRs
  • Lessons learned and enforcement case studies
  • Processes and Procedures
  • Linkages between Complaint Handling, MDRs, Recalls, and CAPA
  • Corrective and Preventive Action
  • Minimize your risk of regulatory actions
  • FDA’s new guidance on risk
  • Preparing for an FDA Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

Become Better With Biostatistics for the Non-Statistician In 10 Minutes

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.

We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.

In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.

biostatistics

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.

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This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.

This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This will be the agenda that will be covered at this webinar:

Why Statistics?

  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

  • Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
  • An SAP template will be given to all attendees.

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

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About the Director:

Elaine brings over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.

She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.