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ICH endorsed PhV training course

Oct 21 2014 8:00AM - Oct 21 2014 5:00PM | King Fahd Palace Hotel Pointe des Almadies Dakar, B.P. 8181 Senegal

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Overview 

REGISTRATION OPEN!

Online Registration

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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.

What You Will Learn 

  • ICH E2D Definitions and standards for expedited reporting (post–approval)
  • ICH E2B (both pre-and post-authorisation) Data elements for electronic submission
  • ICH E2C (R2) Periodic Benefit Risk Evaluation Report (PBRER) Guideline
  • ICH E2E Pharmacovigilance planning

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 Events

22-23 October 2014

4th African Regulatory Conference

24 October 2014

IFPMA Workshop on Counterfeit medicines

Hotel & Travel 

The course will take place at:

King Fahd Palace Hotel

Pointe des Almadies

B.P. 8181

Dakar, Senegal

Tel: +221 33 869 69 69

Contact Information 

Registration questions

Mrs Mabel Brew

Tel: +233 243 288 505

mabel@creativetrendsgh.com

 

Programme details

Ms Gunta Sveke

Tel: +41 61 225 51 55

gunta.sveke@diaeurope.org

Faculty 

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Registration Fees 

Other Fees

Government/Non-profit/Academia
€150.00
Industry International
€490.00
Industry Africa
€340.00
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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