Your Expert Trainer
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..
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:
· Signal Management
· Risk Management/Risk Management Planning
· Drug Safety
· Clinical Research & Development
· Marketing Approval
· Post-Marketing Activities
· Regulatory Affairs
· Medical Affairs
· Quality Assurance
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