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

Your Expert Trainer

International Pharmacovigilance ExpertOver 37 Years of Experience

Rich hands on pharmacovigilance, risk management and signal management experience with several companies including Sanofi Aventis and Johnson & Johnson Certified Lead Auditor and is a..

About Your Expert Trainer

Course Overview and Objectives

Risk Management Planning and Signal Management are two critical processes and crucical steps of pharmacovigilance and must be managed effectively. With increased scrutiny from regulatory authorities on these aspects, pharmaceutical and biotechnology companies are placed under more pressure.

Equip Global’s 3 Day Risk Management Planning & Signal Management in Pharmacovigilance Training Course aims to critically explore existing and developing strategies and tools to plan and optimize the risk management and signal management activities for known and potential risks of a new product. Regulatory aspects, Pharmacovigilance risk management plans, Risk evaluation and Mitigation Strategy, Periodic Safety Update Report (PSURs) and Periodic Benefit Risk Evaluation Report (PBRERs), Signal Management Data Management, Techniques & Tools will be the central theme. Group Interactive Discussions will also analyse “real world” challenges faced by the industry and regulators.

As with all Equip Global Courses, the emphasis is very much on the practical and interactive exercises and real life case studies. In addition to detailed presentations of the subjects, participants will be challenged in actual case studies to apply the principles discussed. It will also encourage the attendees to develop the tools to implement change upon returning to their work place.

Who Should Attend:

This masterclass is aimed at the Directors, Heads of Departments, Managers, Specialists, Officers and Senior Executives from pharmaceutical and biotechnology companies from the following departments:

·         Pharmacovigilance

·         Signal Management

·         Risk Management/Risk Management Planning

·         Drug Safety

·         Clinical Research & Development

·         Marketing Approval

·         Post-Marketing Activities

·         Regulatory Affairs

·         Medical Affairs

·         Quality Assurance

·         Compliance 

Top 5 Benefits of Attending this Masterclass:

·         Find out how you can plan and prepare yourself for regulatory authority inspections

·         Gain practical techniques in MedDRA Coding & Case Processing

·         Find out in-detail about Signal Detection Concepts, Methodologies, Triage,                               Evaluation and Data Management

·         Understand how you can implement the signal management process and strategy                whilst complying with regulatory requirements

·         Develop an effective risk management plan


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  • Asia Pacific Biotech News
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  • Pharma Focus Asia
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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
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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.

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Risk Management Planning and Signal Management in Pharmacovigilance
03 July 2018 - 05 July 2018
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