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Holiday Inn London Kensington Forum

2015 年 09 月 28 日 8:00 上午 - 2015 年 10 月 02 日 1:00 下午

97 Cromwell Road, London, SW7 4DN, United Kingdom

Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements

概览

INFORMATION TO COURSE PARTICIPANTS: PLEASE DOWNLOAD COURSE MATERIAL FROM THE DIA WEBSITE

 

Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course now also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

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What participants from previous course say:
"Thank you for a great and comprehensive course. It was great to hear the perspectives of the different speakers as well as to meet a number of people working within this sector"
"A well organised course in an excellent location.  The course director should be commended!"
"A very interesting course with lots of takeaway reading to do. The meeting was very well organised and the day schedule was kept to plan"

内容纲要

  • Definitions and Methods in Pharmacovigilance
  • Regulatory Aspects in Pharmacovigilance and Practial Examples
  • Diagnosis and Management of Adverse Drug Reactions
  • Signal Detection
  • Risk Management

谁应该参加？

Professionals involved in pharmacovigilance and namely Qualified Persons for Pharmacovigilance (EU QPPV), clinical research, regulatory affairs, risk management, medical product safety assessment, and data analysis, epidemiology, labelling, quality assurance, compliance, medical information.

Level: Intermediate

学习目标

For the five key topics as outlined above, the learning objectives also include the ability to:

  • Describe the main changes to the business processes in the context of the new pharmacovigilance legislation
  • Discuss the latest developments in the area of international harmonisation and standardisation with the main focus on the series of ICH E2 guidelines

项目委员会

  • Gaby L. Danan, MD, PHD
    Gaby L. Danan, MD, PHD Pharmacovigilance Expert
    GLD, France
  • Phil Tregunno
    Phil Tregunno Deputy Director - Patient Safety Monitoring
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Digital Learning Catalog

DIA Learning: eLearning Soultions
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