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Business Glossary First step to Data Governance Success Webinar By EITAGlobal
9/17/2014 10:00 AM - 1:00 PM
Online seminar Fremont, California United States
Event Listing
Summary:

Overview: Often organizations are challenged in selecting the first enterprise wide implementation that the Data Governance (DG) program should address. A Business Glossary is a great first initiative as well as one that provides significant value to the enterprise.

A Business Glossary is the tool for exposing authoritative content from DG initiatives and used to communicate understanding and clarity across the enterprise. A business glossary can connect workers across the enterprise to critical business information they can trust, helping to eliminate misunderstandings that cause lost time, lost opportunities and lost revenue. Creating great definitions and business term names will aid significantly in enabling search capabilities. The Business Glossary should be an early deliverable from your DG program and mature to include the logical and physical data constructs as a valuable component to drive DG maturity and value.

This seminar will be helpful for data management and Governance professionals that have been challenged with any of the following issues:

How to organize the business glossary program for quick wins as well as position for a maturing DG program

Business Intelligence, BPM and KPI ambiguity

Legal and compliance regulations are driving new projects that are not clearly defined (such as TART)

Enterprise or international projects like CDI/MDM that must address terminology and semantic differences across the enterprise

Why should you Attend: Often organizations are challenged in selecting the first enterprise wide implementation that the Data Governance (DG) program should address. A Business Glossary is a great first initiative as well as one that provides significant value to the enterprise. A Business Glossary activity, when addresses as data sprints, can provide the DG program with effective and quick success, as well as great visibility for the program.

Good Governance processes are critical for many enterprises that are:

Unclear how to achieve quick results from Data Governance

Organized geographically introducing global enterprise semantic differences

Challenged by complexity of terminology having many glossaries

Mergers and Acquisitions have introduce semantic differences across the enterprise

Areas Covered in the Session:

Methods for establishing the Business Glossary, standards and best practices

How to leverage your existing Governance team and processes

How to create structured definition standards and name business terms

Techniques to get your Glossary populated and used

Who Will Benefit:

CDO and Director of Data Governance

Data Stewards

Data Governance Analysts and Data Governance team members

Data Architects

Speaker Profile:

Lowell is recognized as a thought leader in business metadata/glossaries, enterprise application integration, DW/BI applications, and Data Governance having hands-on experience with over 80 business intelligence implementations. He has also been recognized by W. H. (Bill) Inmon, and is a contributor to six of his books. Mr. Fryman is a co-author of the book “Business Metadata: Capturing Enterprise Knowledge”. Lowell an Data Architect in the Healthcare Practice of Edgewater Technology Inc. Lowell has achieved a number of certifications including Certified Business Intelligence Professional (CBIP) for ICCP/TDWI and has an MSIT degree.

Clinical Research Foundation for the Application Concepts and Theories
9/18/2014 8:30 AM - 9/19/2014 5:30 PM
Courtyard Miami Downtown Miami, Florida United States
Event Listing
Summary:

Overview:

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

Why should you attend:

For those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information, protection of human subjects and all that this topic encompasses is imperative to know as there federal regulations that must be followed. In addition to federal regulations, there are state statues, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research so that it not only meets the regulatory requirements but so that the study is conducted in an ethical manner containing adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research. Guidelines also provide interpretation of the regulations which are not always as clear as they might appear upon first reading them. Attendance at this two day session will not only provide an introduction or refresher of the regulations, it will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc.) when conducting human subjects

Areas Covered in the Session:

• Department of Health and Human Services regulations, 45 CFR 46

• Office for Human Research Protections Guidance

• The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814

• HIPAA and Hi-Tech

• ICH E6 Good Clinical Practices

• Coercion vs. undue influence

• Recruitment of Research Subjects

• Vulnerable populations

• Non-English speaking populations

• Inclusion of Women and Minorities

• Waivers of consent

• Waivers of consent vs. waivers of authorization

• Assent vs. consent

• Wards of the State

• Certificates of confidentiality

• Levels of de-identification what they are and how they affect consent

• Privacy vs. confidentiality

• Study responsibilities: ICH vs. NIH

• Drug/Device Accountability

• Codes of Conduct

• Conflicts of Interest

• Reporting responsibilities

• Monitoring

• Investigator-sponsor responsibilities

• Study types

• Special concern studies

• Standard operating procedures vs. protocol vs. IRB submission

• Common compliance issues

• Data safety monitoring

• Adverse event monitoring and reporting including Serious adverse events and unanticipated problems

• Investigational Drug and Device use in clinical trials

• Assurances and Agreements (e.g. MOU)

• Site Responsibilities

• International Ethical Guidelines

• Applying ICH to international sites

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

Course Outline:

Day 1 – Agenda

Lecture 1: The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research

Lecture 2: Current Federal Regulations and Agencies involved in Human Research

Lecture 3: Selection and Recruitment of Research Subjects

Lecture 4: Informed Consent in Clinical Trials

Lecture 5: Confidentiality of Clinical Trial Information

Lecture 6: The Investigator

Lecture 7: Research Protocols

Day 2 – Agenda

Lecture 8: Multisite, Community and Collaborative Studies

Lecture 9: The Institutional Review Board

Lecture 10: Patient Safety in Clinical Trials Research

Lecture 11: Research Under the Food, Drug & Cosmetic Act

Lecture 12: International Research

Lecture 13: Compliance and Human Research

Lecture 14: Accreditation and Risk Management in Clinical Trials

About Speaker:

Sarah Fowler-Dixon Education Specialist and instructor, Washington University

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, and submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Date, Venue & Price:

Location: Miami | September 18th & 19th 2014 | 8:30 AM to 5:30 PM

Venue: Courtyard Miami Downtown

200 SE Second Avenue - Miami, Florida 33131 USA

Price: $1,295.00 Register now and save $200. (Early Bird)

Until July 15, Early Bird Price: $1,295.00

from July 16 and September 16, Regular Price: $1,495.00

Event Coordinator

Toll free: 800-385-1607

Fax: 302 288 6884

Email: support@mentorhealth.com

Event Link: http://bit.ly/RDgVcb

Website: http://www.mentorhealth.com

LIVE CHAT SUPPORT -http://www.mentorhealth.com/chat/client.php?

MentorHealth

Net Zealous LLC

43337 Livermore Common, Fremont CA 94539, USA

ConvergeFL 2014
11/7/2014 8:00 AM - 11/9/2014 6:00 PM
TBD Jacksonville, Florida United States
Event Listing
Summary:

ConvergeFL 2014 is back in Jacksonville, FL once again. Join us for two days of discovery, inspiration and know-how.

Digital Marketing for Pharmaceutical and Medical Devices Expectations from FDA
9/4/2014 9:00 AM - 9/5/2014 6:00 PM
Courtyard Chicago O'Hare
Event Listing
Summary:

The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered.

Dont Miss the Opportunity to Attend an Advanced Course on HIPAA Breach Notification Rules
10/30/2014 9:00 AM - 10/31/2014 6:00 PM
Raleigh, NC Raleigh, North Carolina United States
Event Listing
Summary:

Overview:

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Course Outline:

Day 1 – Agenda

Lecture 1: Overview of HIPAA Regulations

• The Origins and Purposes of HIPAA

• Privacy Rule History and Objectives

• Security Rule History and Objectives

• Breach Notification Requirements, Benefits, and Results

Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures

• Patient Rights under HIPAA

• Limitations on Uses and Disclosures

• Required Policies and Procedures

• Training and Documentation Requirements

Lecture 3: Recent and Proposed Changes to the HIPAA Rules

• New Penalty Structure

• New HIPAA Audit Program

• New Patient Rights

• New Obligations for Business Associates

Lecture 4: HIPAA Security Rule Principles

• General Rules and Flexibility Provisions

• The Role of Risk Analysis

• Security Safeguards

• Training and Documentation

Day 2 – Agenda

Lecture 5: HIPAA Security Policies and Procedures and Audits

• HIPAA Security Policy Framework

• Sample Security Policy Content

• Recommended Level of Detail for Policies and Procedures

• The New HIPAA Compliance Audit Protocol

Lecture 6: Risk Analysis for Security and Meaningful Use

• Principles of Risk Analysis for Information Security

• Information Security Management Process

• Risk Analysis Methods

• Risk Analysis Example

Lecture 7: Risk Mitigation and Compliance Remediation

• Typical Security Risks

• Social Media, Texting, e-mail, and Privacy

• Dealing with Portable Devices and Remote Access

• Compliance Planning

Lecture 8: Documentation, Training, Drills and Self-Audits

• How to Organize and Use Documentation to Your Advantage

• Training Methods and Compliance Improvement

• Conducting Drills in Incident Response

• Using the HIPAA Audit Protocol for Documentation and Self-Auditing

Who Will Benefit:

• Information Security Officers

• Risk Managers

• Compliance Officers

• Privacy Officers

• Health Information Managers

• Information Technology Managers

• Medical Office Managers

• Chief Financial Officers

• Systems Managers

• Legal Counsel

• Operations Directors

About Speaker:

Jim Sheldon-Dean Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, and a Vermont-based consulting firm. His firm has been providing information privacy and security regulatory compliance services to healthcare firms and businesses throughout the Northeast and nationally since its establishment in1982.

Lewis Creek provides a variety of advisory, training, assessment, policy development, project management and mitigation services. Its impressive clientele is drawn from among a number of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans and health care business associates.

Mr. Sheldon-Dean has nearly 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development.

Downtown Podcast
8/28/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
Event Listing
Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

Downtown Podcast
9/4/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
Event Listing
Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

Downtown Podcast
9/11/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
Event Listing
Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

Downtown Podcast
9/25/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
Event Listing
Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

Downtown Podcast
9/18/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
Event Listing
Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

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