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How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant by mentorhealth


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    Live Webinar           on

      How to Prevent or Handle Protocol Deviations and Violations to be
      GCP and Regulatory Compliant

    Date & Time:                                                                                                                       

     Tuesday, February 5, 2013           10:00 AM PST | 01:00 PM EST
                                                                                                  Register Now                         
     Duration: 90 Minutes                Instructor: Charles H Pierce

     Location: Online                    Price : $195.00   (for one participant)

                                                                                             Instructor Profile:
                                                                                                        Charles H Pierce
     Overview:                                                                                          Consultant, Clinical
    Deviations and Violations from the agreed upon protocol may very well                             Research / Drug-Device
    affect the scientific validity of the research. For this reason, a well-                               Development
    written protocol, taking onto account the role of all the Inclusion and                  MD, PhD, FCP, CPI is a consultant in
    Exclusion criteria in subject enrollment is a key element in having                      the Clinical Research / Drug-Device
                                                                                             Development arena specializing in
    deviation free study conduct. As the Principal Investigator is responsible
                                                                                             bringing the message of GCP
    for the conduct of the study according to the protocol she/he signed, it is
                                                                                             Regulations and Investigator
    imperative that they ensure that all staff know the protocol and follow it               Responsibility to the entire
    to the letter. If and when a deviation or violation of the protocol is found,            investigative team to help them
    meaning that the protocol was not followed (PNF) it must be reported,                    understand the regulations as well as
    reviewed and acted upon for Corrective and Preventative Action (CAPA).                   the ethics of research involving
    Also, the differences between and differing significances of "Deviations"                human subjects. Dr. Pierce serves as
    and "Violations" must be clearly understood by all persons involved in                   an advisor to several clinical
                                                                                             research organizations, sits on
    the conduct of clinical research studies.
                                                                                             industry based boards, and is VP of
                                                                                             Medical Affairs for Harrison Clinical
                                                                                             Research GmbH, a global CRO
     Areas Covered in the Session:
                                                                                             headquartered in Munich. He has
                                                                                             been in the Clinical Research
                                                                                             Industry for 20 years, has been
        l   How to know when the protocol is not followed (PNF)?                     
                                                                                             involved in developing Phase I & IIa
        l   What is the difference between a protocol deviation and a
                                                                                             Clinical Pharmacology Units,
            violation?                                                                       Investigator and staff GCP training,
        l   Importance of the "Protocol" in the number of deviations                         and medical monitoring in both drug
            occurring                                                                        and device studies. ....more
        l   How to ensure that the protocol will be followed exactly?
        l   What is in the Regs about following the protocol?
        l   When may the Investigator make changes in the protocol?
                                                                                            Suggest a Topic       More Webinars
        l   What are the causes of Protocol Deviations and Violations?
        l   How are Protocol Deviations managed?                                              Your Necessity is our Priority
        l   Examples of Protocol Violations and Deviations

    Click here to register for this webinar

     Who Will Benefit:                                                                                         

        l   Principal Investigators and sub investigators
        l   Clinical Research Scientists (PKs, Biostatisticians)
        l   Research managers
        l   Safety Nurses
        l   Clinical Research Associates (CRAs) and Coordinators (CRCs)
        l   Recruiting staff
        l   QA / QC auditors and staff
        l   tudy Monitors
        l   Clinical Research Data managers.

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

About MentorHealth
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professionals can make use of the best benefits relating to their professional training.

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