Pharmacovigilance Planning and Risk Management
12 November 2013 - 14 November 2013
Manila, Phillippines

Your Expert Trainer

International Expert with 30+ Years Experience in Drug Safety & Pharmcovigilance

Adjunct Professor, Rutgers University 30 years' experience in drug safety & pharmacovigilance Specialist in global safety compliance, business process improvement and signal det..

About Your Expert Trainer

Course Introduction

Equip Global’s 3-day Pharmacovigilance Planning & Risk Management Training Course is a very well established training course aimed to critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product. Regulatory aspects, Pharmacovigilance risk management plans, Risk evaluation and Mitigation Strategy, Periodic Safety Update Report (PSURs) and Periodic Benefit Risk Evaluation Report (PBRERs) will be the central theme. Group interactive sessions will analyse recent 'real-world' challenges faced by marketing authorisation holders and regulators.

Learning Objective

  • Appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue
  • Remain current with global regulatory changes to ensure compliance with new pharmacovigilance, risk management, and adverse event reporting initiatives
  • Create a synchronized regulatory strategy that will ensure safety compliance in pharmacovigilance with FDA and EMA regulators
  • Demonstrate good pharmacovigilance practice and locate key sources of information and documentation
  • Utilize risk management tools such as Period Safety Update Reports (PSUR) and Risk Evaluation & Mitigations Strategy (REMS) to effectively evaluate internal risk
  • Outline how to apply signal detection within their function based on the possibilities and limitations of methodology, data and resources 
  • Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information

Who Should Attend?

  • Professionals working in the area of:
  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance 

More Details

If you like more information about the training course agenda and the expert trainer details, please email

Please indicate subject title as “Pharmacovigilance Planning & Risk Management ”

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" Excellent Training Course and the Trainer’s very knowledgeable " – Risk Management & Drug Safety Specialist, Celgene
" 10/10 for this training course and I learnt a lot " – Drug Safety Manager, Novartis
" Gained a lot of practical knowledge from attending this training course " – Pharmacovigilance Manager, Celltrion
" I would like to thank you for arranging this excellent course on Pharmacovigilance. I have really learnt a lot from the workshop " – Senior Safety Physician, Global Pharmacovigilance, Lundbeck

Sponsorship Opportunites

If you would like to find out more about how sponsorship at this event can help you achieve your sales & marketing objectives, please email Our relevant business development consultant will get in touch with you shortly.

Speaker Opportunities

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Media Partnership Opportunities

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Pharmacovigilance Planning and Risk Management
31 May 2016 - 02 June 2016
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