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 enquiry@equip-global.com

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

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Knowledge Center

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Testimonials

" 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 enquiry@equip-global.com. Our relevant business development consultant will get in touch with you shortly.

Speaker Opportunities

If you have a relevant case study and would like share at this event, please email enquiry@equip-global.com. Our relevant industry consultant will get in touch with you shortly.

Media Partnership Opportunities

If you are keen to embark on joint marketing activities for this or upcoming events, please email enquiry@equip-global.com . Our relevant marketing manager will get in touch with you shortly.

Quick Links

PIC – 40% cash back when you register for an Equip Global Conference or Training Course

The objectives of the PIC Scheme are the same as those of Equip Global. Both support investment in innovation, productivity and continuous training.

If you are a registered business in Singapore, you can enjoy huge huge tax savings in the form of cash payouts and/or tax deductions when you invest in training of employees. Your attendance at any Equip Global conference or training course is eligible for PIC credits, either as a 40% cash refund or 400% tax deduction. We will provide you with full supporting documentation after the event and assist you in getting the claim completed.

Continuous training and upgrading of your employees is key to the success of your organization. What’s more, boost your tax savings and claim 40% of your registration fee by attending an Equip Global conference or training course today. To do so, follow this simple 5 minute process:

  1. Select, register and pay for your conference/training course of your choice
  2. Complete the PIC form which you can download here: http://www.iras.gov.sg/irasHome/uploadedFiles/Quick_Links/Tax_forms/Business_and_employers/Cash%20Payout%20Application%20Form_B2011_final.xls
  3. Attend the event, learn and network with industry peers
  4. File your receipt (which we will email you), record of attendance (which we will provide you at the event) and the completed PIC form with your accounts department which they will submit to IRAS to process the claim. If you do not have an accounts department or need help with the PIC claim, our staff will be very happy to assist.

Take advantage of the PIC scheme to upgrade your skills, gain the latest information in your field of work, and get access to the knowledge that can help drive your organizations’ performance and productivity.

For more information visit http://www.iras.gov.sg/irashome/picredit.aspx. Terms and conditions apply.

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