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Good Pharmacovigilance Practice - Inspection and Audits

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    Live Webinar         on
 
     Good Pharmacovigilance Practice - Inspection and Audits

                                                                                                                                 
     Course "Good Pharmacovigilance Practice - Inspection and
     Audits" has been pre-approved by RAPS as eligible for up to 1.5
                                                                                            Register Now                         
     credits towards a participant's RAC recertification upon full
     completion.


    Date & Time:                                                                       Instructor Profile:

     Thursday, July 5, 2012             10:00 AM PDT | 01:00 PM EDT
                                                                                                      Steve Jolley
     Duration: 90 Minutes               Instructor: Steve Jolley                                  Principal, SJ Pharma
                                                                                                       Consulting
     Location: Online                   Price : $245.00    (for one participant)

                                                                                       Steve Jolley is a subject matter
                                                                                       expert in all areas of global safety
    Overview:                                                                          compliance and signal detection, and
    This webinar will describe how to conduct a thorough drug safety                   is a frequent speaker at leading
    and pharmacovigilance audit, including compliance with applicable                  industry events including DIA and
    worldwide laws, regulations and guidance. In addition, attendees                   MHRA. He has 25 years’ experience
                                                                                       in drug safety & pharmacovigilance
    will learn how to compare the company's pharmacovigilance
                                                                                       and has worked with over 50 clients
    operations to applicable best practices.
                                                                                       in the US, Europe and Japan. He
                                                                                       holds degrees in mathematics and
    The course will cover all aspects of drug safety and                               computer science from Cambridge
    pharmacovigilance compliance including the collection, assessment                  University, England. Steve is a
    and reporting of adverse event cases, the analysis of cases to detect              featured speaker with FDA at DIA
    signals, the management of signals and safety concerns, and the                    conferences and webinars on
    development, execution and monitoring of risk management plans.                    auditing, signaling and data mining.
                                                                                       Steve began his career in the
                                                                                       pharmaceutical industry in 1985
    Why Should You Attend:                                                             when he founded DLB Systems, a
                                                                                       supplier of computer systems for
    During high profile drug withdrawals of the past, most of the focus of
                                                                                       clinical trials and adverse event
    the press and legal community was on the actual adverse event and
                                                                                       reporting to many of the leading life
    the people who were injured. Today the attention seems to be on                    science companies worldwide. DLB
    the documentation of how and when companies learned of the                         was acquired by eResearch
    increased frequency of adverse events and what they did about it.                  Technologies in 1997; since then
                                                                                       Steve has worked as an independent
    Meanwhile, international regulatory guidances on drug safety                       consultant. ...more
    monitoring are increasing. With ICH E2E and E2C, CIOMS VI and VII,
    and the FDA Amendment Act, companies may need to audit their pre-
    marketing and post-marketing safety monitoring practices to ensure   Suggest a Topic                    More Webinars
    they are following Good Pharmacovigilance Practices.
                                                                                        Your Necessity is our Priority
    A pharmacovigilance audit begins with a strong methodology that
    captures the key requirements of all the applicable regulatory
    bodies. It compares a company’s practices to an "ideal" process map
    that includes strategy, infrastructure, tools, execution and
    evaluation.                                                                                          


    Areas Covered in the Session:
    Regulatory Background: matrix of safety regulations; postmarketing
    safety reporting: CFR; International Conference on Harmonisation
    (ICH); ICH topic codes and reports; Council of International
    Organizations of Medical Sciences (CIOMS); Eudravigilance; Clinical
    Trials Directive; Volume 9a

    The Pharmacovigilance Audit: overview of the pharmacovigilance
    audit; typical pharmacovigilance current process model; best practice
    approach to enhancing process model; achieving best practices
    through the pharmacovigilance assessment; value derived; scope;
    company sources of information to be examined; PV checklist; audit
    report table of contents; limited audit


    Practical Tips: Importance of QPPV in Europe; need for oversight of
    the pharmacovigilance system; ensuring information on adverse
    events is accessible; suitability of people; requirements for SOPs;
    processing of ICSRs; electronic reporting; Periodic Safety Update
    Reports (PSURs); signal detection practical tips; quality assurance


    Click here to register for this webinar
  Who Will Benefit:


     l   Drug safety and pharmacovigilance
     l   Regulatory Affairs
     l   Clinical development



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,
Event-coordinator
GlobalCompliancePanel



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DOCUMENT INFO
Description: This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the collection, assessment and reporting of adverse event cases, the analysis of cases to detect signals, the management of signals and safety concerns, and the development, execution and monitoring of risk management plans.