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ICH endorsed PhV training course

Nov 26 2014 8:00AM - Nov 27 2014 5:00PM | Hilton Alger Pins Maritimes El Mohammadia Algiers, 16000 Algeria

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Overview 

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Postponement of ICH endorsed Pharmacovigilance training course
 

DIA Europe, Middle East & Africa announces the postponement of the ICH Endorsed Training Course on Pharmacovigilance to 12-13 February 2015 due to reasons beyond our control.

The adjacent event the 1st Maghreb Regulatory Conference to will also be postponed and will take place on 10-11 February.

DIA remains a committed member of the regulatory and scientific community and advocate for research and capacity building worldwide. 

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This training course focuses on ICH international standards related to pharmacovigilance (ICH E2 series). It covers both pre- and post-authorisation pharmacovigilance standards and practical implementation of the ICH guidelines in the international environment. The course includes case studies and examples of challenges and practical solutions. The course is prepared and taught by experienced pharmacovigilance experts. Participants will gain solid knowledge and a clear understanding of international approaches to drug safety pharmacovigilance, as well as the best practices for successful local and global regulatory applications.
To view the detailed programme please click on View PDF at the top.

Download Registration Form

Online Registration


 

What You Will Learn 

  • ICH E2A Pre-marketing safety
  • ICH E2D Definitions and standards for expedited reporting (post–approval)
  • ICH E2F Development Safety Update Report
  • ICH E2C (R2) Periodic Benefit Risk Evaluation Report (PBRER) Guideline

Who Should Attend 

Professionals with background in the following areas:

  • Clinical Research
  • Clinical Safety / Pharmacovigilance
  • Information Technology / Document Management
  • Public Policy / Law / Compliance
  • Regulatory Affairs
  • Research & Development
  • Risk Management

Learning Objectives 

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

  • Understand the international history, the principles and regulatory framework for pre- and post- approval clinical safety / pharmacovigilance
  • Recognise the need for international safety surveillance and understand the regulatory requirements
  • Understand the basic definitions of terms, scope of work, and purpose of pharmacovigilance used in day-to-day work
  • Demonstrate an awareness of risk management and optimal risk minimisation methods

Special Offers 

Adjacent Event
24-25 November 2014
1st Maghreb Regulatory Conference

Hotel & Travel 

Training Course Venue
Hilton Alger
Pins Maritimes El Mohammadia
Algiers 16000, Algeria
Tel: +213 21 219 696
Website

For hotel reservations, please contact our agent

Creative Trends
Osu Forico Mall, Mission Street
Near Blue Gate, Osu
P.O. Box AN 15605
Accra-North, Ghana
Tel: +233 243 288 505
info@creativetrendsgh.com

Visa requirements
Please contact your local Algerian Embassy or Consulate for the most up-to-date information on visa requirements and how to apply for it if neccessary.
Note: tourist visa applications are usually processed within 15 days.

Vaccinations
Yellow fever: A yellow fever vaccination certificate is required for travellers over 1 year of age arriving from countries with risk of yellow fever transmission and for travellers having transited more than 12 hours through the airport of a country with risk of yellow fever transmission.
Malaria: Malaria risk is limited. Small foci of local transmission (P. vivax) have previously been reported in the six southern and south-eastern wilayas, with 59 local cases of P. falciparum and P. vivax transmission reported in 2012 in areas under the influence of trans-Saharan migration.
Recommended prevention in risk areas: A (Very limited risk of malaria. Mosquito bite prevention only)
http://www.who.int/ith/ITH_country_list.pdf?ua=1

Contact Information 

DIA has appointed Creative Trends to be the organising secretariat for this course.

Training Registration & Accommodation Booking
Creative Trends
Osu Forico Mall, Mission Street
Near Blue Gate, Osu
P.O. Box AN 15605
Accra-North, Ghana
Tel: +233 243 288 505
info@creativetrendsgh.com

Conference Programme
DIA Europe, Middle East & Africa
Kuechengasse 16
4051 Basel, Switzerland
Tel: +41 61 225 51 49
carolin.doerflinger@diaeurope.org

Faculty 

Previous Next

Agenda  

Day 1 Wednesday, Nov 26, 2014

  • 8:00AM - 8:45AM (Central Europe Standard Time)

    REGISTRATION
  • 8:45AM - 9:00AM (Central Europe Standard Time)

    Welcome and Opening remarks
  • 9:00AM - 10:30AM (Central Europe Standard Time)

    Session 1 - Introduction of ICH Pharmacovigilance guidelines
  • 10:30AM - 11:00AM (Central Europe Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:40PM (Central Europe Standard Time)

    Session 2 - ICH E2A pre-marketing safety
    Local perspective
  • 12:40PM - 1:40PM (Central Europe Standard Time)

    LUNCH
  • 1:40PM - 3:30PM (Central Europe Standard Time)

    Practical exercises
  • 3:30PM - 4:00PM (Central Europe Standard Time)

    COFFEE BREAK
  • 4:00PM - 5:30PM (Central Europe Standard Time)

    Session 3 - ICH E2D definitions & standards for expedited reporting (post-approval)
    Local perspective and exercises

Day 2 Thursday, Nov 27, 2014

  • 9:00AM - 10:30AM (Central Europe Standard Time)

    Session 4 - ICH E2C (R2) periodic benefit risk evaluation report (PBRER) guideline + local perspective
  • 10:30AM - 11:00AM (Central Europe Standard Time)

    COFFEE BREAK
  • 11:00AM - 1:15PM (Central Europe Standard Time)

    Session 4 continued
    Practical excercises
  • 1:15PM - 2:15PM (Central Europe Standard Time)

    LUNCH
  • 2:15PM - 3:45PM (Central Europe Standard Time)

    Session 5 - ICH E2F Development Safety Update Report
    Local perspective & practical exercises

Registration Fees 

Other Fees

Industry International
€990.00
Industry Maghreb
€790.00
Nonprofit/Academia/Government
€250.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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