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eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Feb 20 2014 9:00AM - Feb 21 2014 5:00PM | Novotel Bucharest City Centre Calea Victoriei 37B Sector 1 Bucharest Romania 010061

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Overview 

The EMA has prepared this eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU).

The training focuses on explaining the guidance, specifically the mandatory data elements necessary for the electronic submission of information on medicinal products applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool also known as EVWEB.

The course also includes instructions for sponsors of clinical trials as how to provide information on the IMPs in the EudraVigilance Medicinal Product Dictionary (‘EVMPD’) before completing the clinical trials application form.

Who Should Attend 

The XEVMPD training programme is targeting personnel of marketing authorisation holders, consultants and other organisations, who are responsible for the electronic submission and maintenance of information on medicinal products authorised in the EU. It is also targeting sponsors of clinical trials responsible for providing information on IMPs in accordance with the CT-3 detailed guideline.

Learning Objectives 

At the end of this course, participants should be able to:

  • Understand the concepts related to the electronic submission of information on medicines authorised in the EU
  • Describe the format and the data elements of the XEVPRM for authorised medicinal products
  • Discuss practical examples of different types of medicinal products
  • Get hands-on experience in working with the XEVMPD
  • Describe the format and the data elements of the XEVPRM for IMPs

Featured Topics 

  • General Terms and Definitions
  • Registration in EudraVigilance and Qualified Person Responsible for Pharmacovigilance (QPPV) registration
    (incl. sponsor registration)
  • XEVPRM XSD Schema
  • XEVPRM data elements and examples including hands-on exercises
  • Operation Types
  • Data Quality
  • Data Ownership
  • XEVMPD technical validation rules
  • Use of Controlled Vocabularies

Contact Information 

Registration and Agenda:
DIA Europe
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
E-mail: diaeurope@diaeurope.org

For technical questions or registration to EudraVigilance:
Eudravigilance helpdesk for Sponsors:
eudravigilance@ema.europa.eu
EudraVigilance registration team:
eudravigilanceregistration@ema.europa.eu

Hotel & Travel 

Please contact Ms. Madalina Nedelciu from Business Travel to book a hotel room, flight or airport transfer. She will be pleased to assist you.

S.C. BUSINESS TRAVEL TURISM S.R.L.
Aleea Alexandru nr. 9A, 1st Distict,
011821 Bucharest
Romania

Tel. +4 021 2315619
Fax. +4 021 2315622
Mob.+4 0729 835 337
Email: madalina.nedelciu@businesstravel.ro

Special Offers 

It is not possible to register online for this course. Please fill in the registration form at the back of programme (view pdf).

A special discount for SMEs on the standard rate is available. It is not possible to receive this discount when booking online. To proof your status as SME, a confirmation of the European Medicines Agency is necessary.

Multiple course discount available if booked together with the three-day EudraVigilance training course.

Faculty 

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Agenda  

Day 1 Thursday, February 20, 2014

  • 9:00AM - 9:30AM

    Course Introduction, Introduction to EudraVigilance, Registration to EudraVigilance
  • 9:30AM - 10:15AM

    Regulatory Background, General Terms and Definitions, eXtended EudraVigilance Medicinal Product Report Message, (XEVMPRM) Data Set, Operation Types, Data Quality, Data Ownership
  • 10:15AM - 11:00AM

    Database Architecture, Roles of the eXtended EudraVigilance Medicinal Product, Dictionary (XEVMPD) within EudraVigilance, Data Collection Process
  • 11:15AM - 12:45PM

    How to enter product data in the XEVMPD using the EVWEB tool, How to enter an organisation (MAH and Sponsor), How to enter a substance (an approved and a development substance), translations and synonyms
  • 1:45PM - 6:00PM

    Examples of different types of authorised medicinal products, Nationally authorised medicinal product, Medicinal product authorised through the mutual recognition procedure, Centrally authorised medicinal product, Investigational Medicinal Product (Develo

Day 2 Friday, February 21, 2014

  • 9:00AM - 9:45AM

    How to perform simple and advanced queries in the XEVMPD using the EudraVigilance Web-based application (EVWEB)
  • 9:45AM - 11:15AM

    How to maintain product data in the XEVMPD using EVWEB, How to use the operation type “withdraw” for an authorised medicinal product
  • 11:45AM - 1:45PM

    Example how to use the operation type “update” for substance (including the handling of translations and synonyms), Example how to use the operation type “update” for an organisation
  • 2:45PM - 5:15PM

    Knowledge Evaluation, Part 1: Multiple Choice Questions, Part 2: Product Report Exam Case

Registration Fees 

Other Fees

Academia
€585.00
Government (Full Time)
€585.00
Industry
€9042.60
Register Online
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