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What is a Serious Adverse Events and how do I handle these Webinar By MentorHealth
5/15/2014 10:00 AM - 11:00 AM
online event Fremont, California United States
Event Listing
Summary:

Overview: When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.

Serious adverse events are defined by the FDA as "Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death." Although this definition seems clear, there are words within the definition itself that have to be understood in order to ensure compliance. Who is the initial reporter? What is an adverse experience? Is an adverse experience different or the same as an adverse drug experience? How do you know if a more severe form as occurred? Is death the SAE or is the cause of death the SAE?

This webinar will help sort out all these issues and get you to a better understanding of what needs to be reported to who.

Why should you attend: Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.

Areas Covered in the Session:

ICH guidelines and Good Clinical Practice (GCP)

Department of Health and Human Services (DHHS) guidance

Food and Drug Administration (FDA) guidance

Definitions

Potential effects on consent and the protocol

Examples

Links to useful resources

Who Will Benefit:

Human Subjects Research

Healthcare interested in exploring the field of Clinical Research

New Clinical Research Coordinator Positions (1-2 years)

New Principal Investigator Positions

Administration in charge of Clinical Research

Regulatory Compliance

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

MentorHealth

Phone No: 800-385-1607

FaX: 302-288-6884

webinars@mentorhealth.com

Event Link: http://bit.ly/1s5Uz0t

http://www.mentorhealth.com/

Comparing AgileScrum and CMMI How They Can Work Together
5/28/2014 10:00 AM - 11:30 AM
Online Event(World wide) Fremont, California United States
Event Listing
Summary:

Scrum is a pre-defined development lifecycle based on Agile principles. Agile methodologies promote a project-management process that encourages frequent inspection and adaptation, and a leadership philosophy using teamwork, self-organization and accountability. CMMI is a collection of practices that organizations (software, hardware and IT) can adopt to improve their performance. The CMMI comes with two main views (representations), Staged and Continuous. Staged shows all of the Process Areas (groups of related practices) in the form of a road map, allowing organizations to focus on basic improvements before attempting advanced topics. The Continuous representation has the same content but allows for any topic (Process Area) to be selected à la carte.

Effective Portfolio Management Webinar By EITAGlobal
5/13/2014 10:00 AM - 11:30 AM
Online Event(World wide) Fremont, California United States
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Summary:

This webinar is about Effective Portfolio Management. The objective is to help insure that you prioritize and select the right project for your strategic objective so you can manage this portfolio with agility and flexibility in order to adapt to "real life" while delivering the results as required. Are you funding the right projects? Is your staff working on the right task? Are you getting maximum value with the investments you have? Effective Portfolio Management is about getting the highest value of your investments while delivering the best value in accordance with the vision, principles and organization priorities.

From Enterprise Service Bus ESB to Internet Service Bus ISB
5/21/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

We have successfully built and integrated service based applications. Now we want to deploy them in the cloud and take advantage of commercial, cloud-based applications, but the integration challenges become much more complicated than between on-premise applications. Recent surveys show, for example, that companies abandon SaaS solutions because of problems integrating SaaS with on-premise applications.

Improving the Quality of Your Data Models Webinar By EITAGlobal
5/8/2014 10:00 AM - 11:30 AM
Online Event(World wide) Fremont, California United States
Event Listing
Summary:

Based on a combination of original research and practical use of data models in the field, usually under significant time pressure, the presenter has amassed a number of techniques for developing and checking the quality of data models. Models have been developed over the past 25 years in a wide range of industries including CPG, Manufacturing, Insurance, Media, Energy, Telecommunications, Service and Healthcare.

SB Makerspace General Meeting
4/26/2014 2:00 PM
Santa Barbara Makerspace Goleta, California United States
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Summary:

Makers,We have general meetings every Saturday @ 2pm in the makerspace. We'd love to see you there!

2day Inperson Seminar on Medical Device Software Risk Management and Assurance Case at Los Angeles
5/22/2014 9:00 AM - 6:00 PM
WILL BE ANNOUNCED SOON Los Angeles, CA, California United States
Event Listing
Summary:

This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management.

Statistical Analysis for Product Development 2day Inperson Seminar
4/24/2014 8:30 AM - 4/25/2014 1:00 PM
Hyatt Place Madison/Downtown Madison, California United States
Event Listing
Summary:

This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible.

Starship Showcase Casino Party at NASA
5/15/2014 9:15 PM - 11:59 PM
NASA Ames Research Center Mountain View, California United States
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Summary:

Play casino games, drink libations, enjoy appetizers, and check out space hardware with top startup founders and investors at this special event at NASA Ames.

Get your tickets today at http://showcaseshowdown15.eventbrite.com/

The Licensing Agreement in Pharma and Biotech Understanding how to Negotiate to a WinWin Scenario
4/29/2014 10:00 AM - 11:00 AM
Online Event Palo Alto, California United States
Event Listing
Summary:

This webinar, designed for pharmaceutical and biotechnology companies, will examine key factors that should be considered in drafting and executing a successful licensing agreement that will stand the test of time, and that will meet the expectations of both the licensee and the licensor.

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