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Introduction to Pharmacovigilance
Successfully monitor your drug safety profile and avoid inspection findings
15 – 17 October 2017
Kempinski Hotel, Mall of the Emirates, Dubai, UAE
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Overview

Withdrawal of an expensively developed product is a big hit for companies – and for the patients relying on the medicine – especially when it could have been avoided through effective safety monitoring and risk management. Industry cannot afford to waste the investments made in the clinical and marketing activities of new products through poor adverse drug reaction reporting practices.

This course will review the regulatory environment in which you operate and will guide you through the requirements. You will be given the chance to work on case study exercises to produce practical advice and develop adequate strategies to handle reporting requirements.

If you need to gain in-depth knowledge on the best way to collect and report adverse events and safety data and manage risk, then this is the course for you. Its format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.

Course Content
  • Introduction To Pharmacovigilance
  • The PV System
  • Management And Reporting Of Adverse Events
  • Periodic Safety Update Reports
  • Signal Detection
  • Risk Management Systems
  • Risk Management Planning
  • Implementation Of Risk Minimisation Measures
  • Post Authorisation Studies
  • Evaluation Of Effectiveness Of Risk Minimisation
  • PV Audits And Inspection
Who Should Attend

Suited to staff who have entered this field in the past two years and who need to develop an understanding of pharmacovigilance, such as:

  • Drug Safety / Pharmacovigilance Staff
  • Regulatory Affairs Staff
  • Anyone wishing to build or update their knowledge on adverse event reporting and drug safety information
  • Clinical Development Staff
  • Clinical Research Organisation Staff
Benefits Of Attending
  • Effectively monitor your drug safety profile and avoid inspection findings
  • Manage risk and post-marketing issues that can adversely affect your drug sales revenue
  • Identify and follow up the key signals over time and take corrective and preventive action
  • Regulatory requirements: What are the local and global requirements?
  • Compile and present key information in your adverse event reports in a clear format and reduce errors of interpretation
  • Prepare PSURs – when and how to change

    Dr Michael Forstner
    Managing Partner
    Mesama Consulting, Switzerland

    Michael is an experienced pharmacovigilance and pharmacoepidemiology executive with extensive expertise in all areas of drug safety and benefit-risk management in the pharmaceutical and biotech industries, as well as significant R&D experience in academic and industrial settings. After gaining his PhD in biochemistry from the Swiss Federal Institute of Technology, Michael began his career in oncology research, before moving into R&D and risk management roles at companies such as Roche and Novartis. In 2013, he became the Head of Pharmacovigilance at Boehringer Ingelheim in Vienna, before being appointed the overall European lead in 2014.

    Michael is now a managing partner at Mesama Consulting in Switzerland. He has worked extensively in Europe, the US, Japan and emerging markets such as Latin America and the Middle East, delivering training and consulting assignments on pharmacovigilance and risk management. Michael is a regular conference speaker and has also authored or co-authored more than 20 papers.



    Kempinski Hotel, Mall of the Emirates

    Dubai, United Arab Emirates


    Kempinski Hotel Mall of the Emirates

    Celebrate the 10 year anniversary of Kempinski Hotel Mall of the Emirates which is connected to the award winning Mall of the Emirates, retailing 560 prestigious brands, a 24 screen multiplex cinema and the region's largest indoor ski slope and snow park.

    With 393 rooms and suites, including 20 stunning Aspen Chalets, we boast some of the most unique and modern accommodations. All rooms are well equipped with the state of the art technology for your comfort.

    A destination guaranteed to create memorable moments for business or leisure travelers; we welcome you to a five star luxury retreat.


    Kempinski Hotel Mall of the Emirates Dubai
    Sheikh Zayed Road, Al Barsha
    P.O. Box 120679
    Dubai, United Arab Emirates

    Tel +971 4 341 0000
    Fax +971 4 341 2327

    https://www.kempinski.com/en/dubai/mall-of-the-emirates

    Accommodation

    Special delegate rates have been negotiated at selected hotels and we highly recommend you secure your room reservation at the earliest to avoid last minute inconvenience. You can contact the Hospitality Desk for required assistance on:

    T:+971-4-407 2693
    F:+971-4-407 2517
    E: hospitality@informa.com


    VISAS

    Delegates requiring visas should contact the hotel they wish to stay at directly, as soon as possible. Visas for non-GCC nationals may take several weeks to process.


Date Course Fee Before
6 August 2017
Course Fee Before
10 September 2017
Final Fee
15 – 17 October 2017
(BC6941)
US$ 2,995 US$ 3,495 US$ 3,995

Course fees include documentation, luncheon and refreshments. Delegates who attend all sessions and successfully complete the course assessment will receive an Informa Certificate of Completion.

*

Book and pay full fee for two colleagues and the third attends for FREE

  • Not applicable in conjunction with corporate discounts
  • Payment to be settled before start of the course to avail the offer
  • This offer is not applicable on Early Bird Prices

For more information, email Andy Watts on a.watts@informa.com

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