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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
8/27/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

How to Get Your Combination Product Approved and onto the US Marketplace
8/14/2014 9:00 AM - 8/15/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing
Summary:

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

How to Properly Handle HIPAA Security Incidents and Actual Breaches Webinar By MentorHealth
8/13/2014 10:00 AM - 11:30 AM
online event
Event Listing
Summary:

Overview: The word "breach" in the health care industry, and for those business associates of covered entities, certainly causes alarm when not only have you had your patient's privacy violated, but also now you have to prepare for the financial cost to remedy the breach and think about the possible criminal and civil penalties that you or your organization may have to face.

In addition, because the HITECH Act for the first time now authorizes a federal lawsuit for a HIPAA violation, an aggrieved individual may ask the attorney general of the state in which the violation occurred to sue on his behalf in federal court and recover damages, attorney's fees, and costs. As of the end of August 2011, the Connecticut Attorney General ("AG") had filed two such lawsuits and the Indiana AG had filed one.

In the first one filed, the Connecticut AG obtained a $250,000 settlement from the hospital defendant. Thus, a covered entity now faces the possibility of HIPAA lawsuits in both state and federal courts. Further, with the HITECH Act's expansion of HIPAA civil and criminal liability to business associates, the latter may also be sued in federal court. The Minnesota Attorney General has filed such a lawsuit against a business associate. Isn't it better to know the proper way to handle a breach according to the law?

Learn the difference between security incident reports and reportable breaches and how to handle each properly during this 90-minute seminar. Find out what resources are available to you to help avoid breaches of confidentiality and how your organization can be better prepared for HIPAA compliance regulations

Areas Covered in the Session:

What is a security incident?

What is a breach?

What immediate action should be taken when a breach is suspected?

How to report a breach

How to investigate a breach

How to mitigate the harm of a breach

What breaches must be reported to DHHS and/or to the individuals who are the subject of the breach?

How to report breaches to DHHS and/or to the individuals who are the subject of the breach

How to determine whether disciplinary action is appropriate

How to document security incidents and breaches in a security incident report

Do you need insurance to cover HIPAA breaches?

Who Will Benefit:

HIPAA Compliance Officers

HIPAA Security Officers

HIPAA Privacy Officers, CFOs

CIOs

Medical Records Personnel

Health Information Management Professionals

Health Care Attorneys

Billing Services

Educational Objectives(S)

Upon completion of this activity, participants will be able to:

Discuss the difference between security incident reports and reportable breaches and how to handle each properly.

CME Credit Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of CFMC and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.

CFMC designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals Credit Statement

This educational activity has been planned and implemented following the administrative and educational design criteria required for certification of health care professions continuing education credits. Registrants attending this activity may submit their certificate along with a copy of the course content to their professional organizations or state licensing agencies for recognition for 1.5 hours.

Disclosure Statement

It is the policy of CFMC and MentorHealth that the faculty discloses real or apparent conflicts of interest relating to the topics of the educational activity. All members of the faculty and planning team have nothing to disclose nor do they have any vested interests or affiliations

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Obtaining Certificate of Credit

Colorado Foundation for Medical Care (CFMC) hosts an online activity evaluation system, certificate and outcomes measurement process. Following the activity, you must link to CFMC's online site (link below) to complete the evaluation form in order to receive your certificate of credit. Once the evaluation form is complete and submitted, you will be automatically sent a copy of your certificate via email. Please note, participants must attend the entire activity to receive all types of credit. Continuing Education evaluation and request for certificates will be accepted up to 60 days post activity date. CFMC will keep a record of attendance on file for 6 years.

Background :

A number of HIPAA standards require covered entities and now, by virtue of the HITECH Act and the Omnibus Rule, to have policies and procedures to handle HIPAA security incidents, even those that do not result in an actual breach of confidentiality. The largest civil money penalties are reserved for breaches that are not handled properly.

Richard D. Dvorak J.D., is a health care attorney and partner in the law firm of TOMES & DVORAK, CHARTERED, a Kansas City area law firm. The firm has Martindale-Hubbell’s highest rating, AV (“A” is for preeminent in the field of practice and “V” is for highest ethics). After serving eight years in the United States Marine Corps, Richard obtained his law degree from Chicago-Kent College of Law in 1992. He is licensed to practice law in Illinois, Missouri, and Kansas, including various U.S. federal courts. Mr. Dvorak’s extensive litigation experience includes medical malpractice, physician licensure, mental health disability cases, military cases, and criminal cases, among others.

Mr. Dvorak is Vice President of EMR Legal, Inc., a national HIPAA consulting firm, which provides consulting services for clients ranging from a large county government, with eight different health entities that need HIPAA compliance help, to a small transcription service. His specialty is helping covered entities and business associates comply with HIPAA in a cost-effective manner using his extensive technical computer knowledge and business acumen. He and his team have consulted over 1,000 clients in health care regulations since 1998. Mr. Dvorak is also the Vice President of Veterans Press, Inc.—a national publishing company that sells and distributes The Compliance Guide to HIPAA and the DHHS Regulations, soon to be in the 6th edition, an integral part of the HIPAA Compliance Library.

How to do a Risk Analysis Webinar By MentorHealth
8/14/2014 10:00 AM - 11:30 AM
online event Fremont, California United States
Event Listing
Summary:

Overview: If you cannot remember the last time your organization performed a HIPAA & HITECH Act Risk Analysis, or if you are unsure if your organization has ever performed a Risk Analysis, then this is the webinar for you. Jonathan P. Tomes will cover how to conduct a risk analysis and how to update it as necessary. Failure to conduct a written risk analysis qualifies as "willful neglect," which carries the highest civil money penalty ("CMP") and which penalty cannot be waived by DHHS as can violations due to a reasonable cause.

Because a risk analysis is a required implementation specification under the Security Rule, failure to do one is willful neglect. And the civil money penalties are not the only sanctions for not doing a risk analysis. The remediation costs for a breach that might have been prevented had a risk analysis been done can be much more than the CMP. Blue Cross Blue Shield of Tennessee not only had to pay the $1.5 million settlement, but also it incurred $17 million in remediation costs-costs that might have been avoided had it done an updated risk analysis.

Why should you attend: The majority of the DHHS civil money penalties and settlements in lieu thereof involve, sometimes with other violations, failure to perform a written risk analysis. These penalties usually are in the seven figure range. Blue Cross Blue Shield of Tennessee, for example, settled for $1.5 million for failing to update its risk analysis when its physical security situation changed. Other seven-figure settlements involved failure to do the required initial risk analysis.

Areas Covered in the Session:

What is risk analysis?

Why do you need to do one?

How to do one

Assemble a good team

Identify assets

Identify risks

Quantify risks

Select reasonable, appropriate, and cost effective security measures

Test and revise security measures

Particular areas to focus on (portable devices, social media, email, and the like)

Case study (will walk webinar attendees through the process)

Questions and answers

Who Will Benefit:

HIPAA compliance Officers

HIPAA Security Officers

HIPAA Privacy Officers

Human Resources Directors

Business Office Managers

Medical Records Personnel

Health Care Attorneys

Patient Accounts Managers

Business Associates

Background :

HIPAA requires a risk analysis of threats to protected health information (“PHI”). Even if risk analysis were not required, one cannot possibly implement reasonable and appropriate security measures to protect PHI without first having completed a risk analysis. If one implements a security measure without conducting a risk analysis, it is just guessing.

And most covered entities and business associates have not completed this most important compliance requirement. The Department of Health and Human Services (“DHHS”) recent audits of covered entities revealed that 47 out of 61 had not conducted a satisfactory risk analysis. This lack of risk analyses is likely because of neglect or failure to understand the need therefore and how to do one.

Jonathan P. Tomes , J.D., is a health care attorney and partner in the law firm of TOMES & DVORAK, CHARTERED. He has written more than 50 books, including The Compliance Guide to HIPAA and the DHHS Regulations, and dozens of articles in the area of HIPAA compliance.

Human Subjects Protection Two Day Seminar
7/24/2014 8:30 AM - 7/25/2014 5:30 PM
San Francisco, CA San Francisco, California 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 1: San Francisco | July 24th & 25th 2014| 8:30 AM to 5:30 PM

Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00

Register now and save $200. (Early Bird)

Until May 31, Early Bird Price: $1,295.00

From June 01 to July 22, Regular Price: $1,495.00

Location 2: Miami | September 18th & 19th 2014 2014 | 8:30 AM to 5:30 PM

Venue: WILL BE ANNOUNCED SOON

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

Human Subjects Protection Ethical Research and Institutional Review Boards IRB s
7/24/2014 8:30 AM - 7/25/2014 5:31 PM
DoubleTree by Hilton Hotel San Francisco Airport 835 Airport Blvd San Francisco, California United States
Event Listing
Summary:

Human Subjects Protection, Ethical Research and Institutional Review Boards (IRB) s

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 1: San Francisco | July 24th & 25th 2014| 8:30 AM to 5:30 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport

835 Airport Blvd, Burlingame CA 94010-9949

Price: $1,295.00

Register now and save $200. (Early Bird)

Until May 31, Early Bird Price: $1,295.00

From June 01 to July 22, Regular Price: $1,495.00

Location 2: Miami | September 18th & 19th 2014 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

ICH GCPs and the Clinical Research Process Including Phase 0123 and Phase 4 trials
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar presents a comprehensive overview of the ICH GCP and other clinical requirements for conducting clinical trials. Learn about the ICH GCP, use of the ICH GCP during clinical trials and the general concepts upon which clinical trials are based. This webinar allows clinical professionals to prepare for and conduct clinical trials.

IOS Bootcamp
7/21/2014 8:00 AM - 7/24/2014 4:00 AM
Fox Valley Technical College Appleton United States
Event Listing
Summary:

In this advanced seminar you will receive in-depth training on Objective-C programming techniques. Learn to leverage the new features in iOS 7 and Xcode.

Ice House Entrepreneurial Program
6/3/2014 5:00 PM - 8/7/2014 7:00 PM
Kauffman Labs Kansas City, Missouri
Event Listing
Summary:

The Ice House Entrepreneurship Program is a revolutionary online learning program designed to inspire and engage participants in the fundamental concepts of an entrepreneurial mindset and the unlimited opportunities it can provide.

International Conference on Business and Social Sciences 2015
3/5/2015 8:00 AM - 3/7/2015 5:00 PM
COSMOSQUARE HOTEL AND CONGRESS Osaka Japan
Event Listing
Summary:

We are now accepting submissions in any area related to Business and Social Sciences fields, and all submissions will be refereed, and accepted papers will be included in the official conference proceedings, which will have an assigned ISBN number.

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