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The Idea Hub
7/23/2014 1:00 AM - 9/1/2014
London London United Kingdom
Event Listing
Summary:

Idea Hub connects innovators and entrepreneurs with big established companies

We are now running a call for some great new ideas so please check our website

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

FDAs Regulation of Regenerative Medicine including Stem Cell Treatments Tissue Engineering and Gen
7/24/2014 8:30 AM - 7/25/2014 4:30 PM
Irvine Marriott Irvine, California United States
Event Listing
Summary:

Regenerative medicine focuses on harnessing the power of one’s own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administration’s (“FDA”) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated – by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

FDAs Regulation of Regenerative Medicine including Stem Cell Treatments Tissue Engineering and Gen
7/24/2014 8:30 AM - 7/25/2014 4:30 PM
Irvine Marriott Irvine, California United States
Event Listing
Summary:

Course "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

Understanding and Implementing the Medical Device Directive 2Day Inperson Seminar
7/24/2014 8:30 AM - 7/25/2014 4:30 PM
Courtyard Chicago Downtown/River North chicago, Illinois United States
Event Listing
Summary:

Course "Understanding and Implementing the Medical Device Directive" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

2day Inperson Seminar on Applied Statistics for QA QC Manufacturing and Design Control
7/24/2014 9:00 AM - 7/25/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing
Summary:

This seminar provides a practical approach to understanding how to interpret and use a standard tool-box of statistical methods, including confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

2day Inperson Seminar on Advanced Course Validation and 21 CFR 11 Compliance of Computer Systems
7/24/2014 9:00 AM - 7/25/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing
Summary:

This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools

Seminar on How to create a company harassment policy By TrainHR
7/24/2014 9:00 AM - 7/25/2014 6:00 PM
DoubleTree by Hilton Hotel San Francisco Airport Burlingame, California United States
Event Listing
Summary:

Overview:

The workshop will start by assessing the group's "IQ" on what is workplace harassment by reviewing several scenarios. When a male supervisor harasses a male subordinate by engaging in verbal abuse and taunting gestures, does this constitute harassment? If an employee reports harassment and the complaint is immediately addressed, however, the harassment continues - does the employee have a case for harassment? When two employees are engaged in consensual relations, can this create a sexual harassment claim? The answers may surprise you. The purpose of this exercise is to heighten participants' awareness that harassment is not always black and white.

Why should you attend:

Harassment is very damaging to the work environment and business. It results in lost productivity, negative public relations, unnecessary litigation, excessive costs and ultimately damages employee morale. From January to September 2010, the EEOC received 99,992 charges which is the highest number of charges in the agency's 45 year history. Over this same time period the agency collect over $319 million in monetary benefits for individuals - which is the highest collected through administrative enforcement in the Commission's history (source: www.eeoc.gov/eeoc/statistics/enforcement/sexualharassment.ofm). Another alarming statistic is that with every 1.5% increase in unemployment, there is a 21% increase in litigation.

While just "general" harassment in the workplace is not actionable, employees do have rights with regard to harassment if the harassment is based on what is called a "protected class". Protected classes include protection from harassment based on sex, age, race, handicap/disability, national origin and religion. Therefore, if an employer subjects an employee to harassment because the employee is a member of a protected class, it could cost hundreds of thousands of dollars (in some cases over $1 million).

Areas Covered in the Session:

Legislation overseeing harassment & discrimination

Examples of harassment

Creating a company harassment policy

Conducting an investigation

Workplace factors that impact harassment

HR management

Texting and Email With Patients Under HIPAA
7/24/2014 10:00 AM - 11:30 AM
online event Fremont, California United States
Event Listing
Summary:

Overview: This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. The session will explain how to discuss communications options with individuals so that you can best meet their needs and desires, while preserving their rights under the rules.

With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the regulations and meeting the e-mail and texting communication needs and desires of its providers and patients. You need the proper privacy protections for health information, and the necessary documented policies and procedures, as well as documentation of any actions taken pursuant to your policies and procedures. Your policies and procedures will probably need major revisions to maintain compliance in areas such as individual access of records, accounting of disclosures, and breach notification. And, of course, you will need to train your staff in all the new policies and procedures.

E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used for health care purposes, including the use of e-mail and texting. Doctors are finding that texting is far more flexible, convenient, and effective than paging, and patients want to be able to use short message texting for handling of appointments, updates, and the like, where even e-mail or the telephone would seem inconvenient.

In order to integrate the use of e-mail and texting into patient communications, it is essential to perform the proper steps in an information security compliance process to evaluate and address the risks of using the technology. This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate e-mail and texting into your organization in a compliant way. The process, including the use of information security risk analysis, will be explained, and the policies needed to support the process will be described.

But the process must also include consideration of various patient access requirements in the HIPAA Privacy Rule. There are new requirements to provide patients electronic access of electronically held PHI which raise new questions of how that access will be provided and how the information will be protected during and after access. And there has long been a HIPAA requirement for covered entities to do their best to meet the requests of their patients for particular modes of communication, and using e-mail or texting is no exception.

The stakes are high - any improper exposure of PHI may result in an official breach that must be reported to the individual and to the US Department of Health and Human Services, at great cost and with the potential to bring fines and other enforcement actions if a violation of rules is involved. Likewise, complaints by a patient if they are not afforded the access they desire can bring about HHS inquiries and enforcement actions, so it is essential to find the right balance of access and control.

HHS compliance audit activity and enforcement penalties are both increased, especially in instances of willful neglect of compliance, if, for instance, your organization hasn't adopted the complete suite of policies and procedures needed for compliance, or hasn’t adequately considered the impact of e-mail or texting on your compliance.

The session will discuss the requirements, the risks, and the issues of the increasing use of e-mail and texting for patient and provider communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. In addition, the session will discuss how to be prepared for the eventuality that there is a breach, so that compliance can be assured.

Why should you attend:

The HIPAA Omnibus Update rules contain numerous changes to HIPAA Privacy, Security, and Breach Notification rules that affect communication with patients and clients of health care services, who often ask to communicate with health care offices via e-mail or text message. Many of the policies and procedures in place at every health care-related organization will need to be reviewed and updated to meet the new requirements. Organizations need to understand the various ways that health care communications can take place, and how patient communications fit in with the HIPAA rules. They need to design and implement a patient communication policy and plan, and train their staff on it, or they may face significant new fines for noncompliance.

E-mail and texting present new challenges to health care providers, as there are simultaneously new requirements to share information with patients, and a new enforcement effort to ensure the privacy and security of Protected Health Information (PHI). Meeting both challenges requires careful consideration of all the regulations and technologies, as well as patient preferences and work flow.

Most HIPAA covered entities now face difficult choices between compliance and ease of communication. Most organizations haven’t updated their information security risk analysis or policies and procedures and run the risk of breaches, rule violations, and fines in the event of mishandling of PHI using these new technologies.

Areas Covered in the Session:

Find out the ways that patients want to use their e-mail and texting to communicate with providers, and the ways providers want to use e-mail and texting to enable better patient care

Learn what are the risks of using e-mail and texting, what can go wrong, and what can result when it does

Find out about HIPAA requirements for access and patient preferences, as well as the requirements to protect PHI

Learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires

Find out what policies and procedures you should have in place for dealing with e-mail and texting, as well as any new technology

Learn about the training and education that must take place to ensure your staff uses e-mail and texting properly and does not risk exposure of PHI

Find out the steps that must be followed in the event of a breach of PHI

Learn about how the HIPAA audit and enforcement activities are now being increased and what you need to do to survive a HIPAA audit

Who Will Benefit:

Compliance Director

CEO

CFO

Privacy Officer

Security Officer

Information Systems Manager

HIPAA Officer

Chief Information Officer

Health Information Manager

Healthcare Counsel/lawyer

Office Manager

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.

MentorHealth

Roger Steven

Phone No: 800-385-1607

FaX: 302-288-6884

webinars@mentorhealth.com

Event Link: http://bit.ly/1kaP5df

http://www.mentorhealth.com/

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