Subscribe to Events Feeds

278 Results Found

Entrepreneurship Sessions with Sameer Shalaby
4/28/2014 2:00 PM - 4:00 PM
ThinkLab at the University of Mary Washington Fredericksburg, Virginia United States
Event Listing
Summary:

The iCenter is a startup incubator that was founded, by Sameer Shalaby, in October 2013 to help entrepreneurs, and members of the Fredericksburg community formulate their business ideas to incubate and take them from a successful launch successful to funding to ultimate exits.

Eseed Entrepreneurship Training
2/24/2014 1:00 AM - 5/19/2014 4:00 AM
FVTC Waupaca Regional Center Waupaca, Wisconsin United States
Event Listing
Summary:

E-seed™ assists start-up, early-stage entrepreneurs and experienced small business owners in developing management and planning tools for their businesses.

Eseed Entrepreneurship Training
5/13/2014 6:00 PM - 8/12/2014 9:00 PM
D.J. Bordini Center Appleton, Wisconsin United States
Event Listing
Summary:

Thinking of starting a business? Need help? E-seed™ assists start-up, early-stage entrepreneurs and experienced small business owners in developing management and planning tools for their businesses.

Ethical Issues in Human Subjects Research Webinar By MentorHealth
5/7/2014 10:00 AM - 11:00 AM
online event Fremont, California United States
Event Listing
Summary:

Overview: This webinar is a compilation of information in areas that generate the most questions for human subject's researchers when conducting research internationally. Discussed in this webinar will be: 45 CFR 46.111 (a)(2) which states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." So what is risk assessment and how does that affect you? The Criteria for Approval found in both the FDA and HHS regulations stipulates what will be looked at during the approval process yet many do not know how, under which conditions, their study is reviewed and therefore do not anticipate possible questions in their study design.

The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. Even if the study is not NIH funded the principles in the Federalwide Assurance apply. Because of this assurance, additional criteria get applied to studies. When does that happen? Why? Can it be avoided? These questions and more will be answered by learning the information presented in this webinar.

Why should you attend: All researchers want their studies be reviewed and approved quickly. Most investigators do not think about regulatory criteria when designing a study. Complicating matters is the current trend to conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements.

The consent document and process are always areas that generate questions. What can and cannot be used? Why? What is allowable? Risks, benefits and how those are viewed and accessed also confound and befuddle individuals working in this field. Knowing what to consider and what the possible stumbling blocks could be, make getting an approval to conduct human subject's research easier. Attendance at this webinar will do just that. It will not only give you a working knowledge of the areas that create the most confusion, it will also give you an understanding that will help you avoid or work through these areas faster and be of assistance to those around you.

Areas Covered in the Session:

Assurances: What are these? What do they stipulate? How they affect you as a researcher

Criteria for review. What to think about and consider when developing or conducting your study

Consent and assent. What is required? What choices do you have?

Community research. What is involved when you ask a private physician to conduct your study or to recruit from his/her clinic?

Risk/Benefit Assessment. What is it? Who makes the determination? What does that determination mean with regards to additional requirements? What is allowable?

Who Will Benefit:

Principal Investigators / Sub-investigators

Clinical Research Scientists (PKs, Biostatisticians,)

Safety Nurses

Clinical Research Associates (CRAs) and Coordinators (CRCs)

Recruiting Staff

QA / QC auditors and Staff

Clinical Research Data Managers

Human Research Protection Professionals

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/1pM4cgK

http://www.mentorhealth.com/

Eugene Startup Weekend
5/2/2014 6:00 PM - 5/4/2014 9:00 PM
University of Oregon's Erb Memorial Union, EMU Eugene,, Oregon United States
Event Listing
Summary:

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.

European Union Filings and Registrations
4/25/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Everywhere Else Tennessee National Startup Conference
4/30/2014 7:00 PM - 5/2/2014 11:00 PM
409 South Main Building Memphis, Tennessee United States
Event Listing
Summary:

Three day summit style conference with hundreds of entrepreneurs, investors, & creatives. National recognized speakers, a Startup Showdown and plenty of after hours events.

FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND
4/25/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

FDAs GMP Expectations for Phase I and FirstinMan Clinical Trials 2day Inperson Seminar
5/29/2014 8:30 AM - 5/30/2014 3:30 PM
Tampa Marriott Waterside Hotel Tampa, Florida United States
Event Listing
Summary:

Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements.

FredLug Meetup
4/26/2014 9:00 AM - 11:00 AM
England Run Library Fredericksburg, Virginia United States
Event Listing
Summary:

A Linux Users Group to meet and talk about Open Source and Linux. We discuss a variety of subjects from very technical to high level all concentrated in providing IT solutions using Open Source and Linux.

Events Map