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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

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


Potential effects on consent and the protocol


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.


Phone No: 800-385-1607

FaX: 302-288-6884

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Perth Starters
5/15/2014 6:00 PM - 7:30 PM
Windsor Hotel, South Perth South Perth Australia
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5/16/2014 6:00 PM - 5/18/2014 9:00 PM
FORUM Aix-en-Provence France
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5/16/2014 6:00 PM - 5/18/2014 9:00 PM
Millsaps College Jackson, Mississippi United States
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Startup Weekends are 54-hour events designed to provide superior experiential education for technical and non-technical entrepreneurs. Beginning with Friday night pitches and continuing through brainstorming, business plan development, and basic prototype creation, Startup Weekends culminate in Sunday night demos and presentations.

Startup Weekend Pays dAix
5/16/2014 6:00 PM - 5/18/2014 10:00 PM
FORUM Aix-en-Provence France
Event Listing

Un Startup Weekend (SW) est un événement se déroulant sur 54h, mettant à disposition des entrepreneurs participants un réseau, des ressources et un encadrement leur permettant de passer le temps d’un weekend de l’idée à la startup.

Research Commercialization From Ideas to IPO
5/19/2014 9:00 AM - 5/20/2014 5:00 PM
Millennium Gloucester Hotel London Kensington London United Kingdom
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This conference will provide an international forum for knowledge transfer that will enable different sectors to develop new government- university-industry -investor collaborations. Thought leaders representing a wide range of government, academic, and industrial experts all of whom understand the necessity for an international partnering platform, will address what has worked, what has failed, and concrete steps to improve global economic innovation and job creation. Together they will explore ways to translate entrepreneurial innovations into economic growth.

SF MusicTech Summit XV
5/20/2014 9:00 AM - 5:00 PM
Hotel Kabuki San Francisco, California United States
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The SF MusicTech Summit brings together visionaries in the evolving music/business/technology ecosystem.

Price: $25 off with startupdigest

Hack Night
5/20/2014 6:00 PM - 10:00 PM
Assembly Coworking Space Calgary Canada
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Every Tuesday night from 6pm to 10pm, “Hack Nights” come alive with hustlers, hackers and hipsters coming together to work on their start-up ideas. If you are working on something tech related, and are in the pre-investment stage, this event is for you

Weekly Open Make Night
5/20/2014 6:00 PM - 9:00 PM
Tampa Hackerspace Tampa, Florida United States
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Lets get together to build some cool projects and meet some very cool people. Join us to work on your stuff, bounce ideas off of members and socialize.

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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
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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.

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