Wednesday, April 17, 2013

Webinars: Important Updates on New European Pharmacovigilance Requirements

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Important Updates on New European Pharmacovigilance Requirements
    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
       EMA Risk Management Development and Scientific Lead, European Medicines Agency
    • Joanna Faith Haas, MD, MSc, FACPM, FISPE, Founding Partner, Haas and Partners
    • Steve Jolley, MA, Principal, SJ Pharma Consulting
With the new European Pharmacovigilance legislation that went into effect in July 2012, implementation is ongoing. Hear from global experts on the impact of the new Pharmacovigilance legislation and important updates since the legislation went into effect.
Does your company understand the processes to perform adequate Benefit-risk assessment?
Your product could suffer significant consequences if your company does not have the proper systems and processes in place. In just two 90-minute sessions you will gain a better understanding of how to work to meet EU standards and become better prepared to implement regulatory requirements for signaling and risk management.
Featured Topics:
    Part One:
    • EU Regulatory Framework
    • Ongoing Timeframe for Implementation of the New Legislation
    • GVP Modules and Implementing Measures
    • PV System Master File (PSMF)
    • Audit and Inspection
    • ADR Reporting
    • The Pharmacovigilance Risk Assessment Committee (PRAC)
    Part Two:
    • Risk Management Plans: Risk Assessment and Risk Minimization
    • Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER)
    • Signal Management
    • Post Authorization Studies of Safety (PASS) and Efficacy (PAES)
    • Implications for International Harmonization
    • And More...
You’ll Learn:
    • New EU regulatory requirements for drug safety
    • How to process adverse events to meet EU requirements
    • What to expect in a European Pharmacovigilance inspection
    • Differences between the old PSUR and the new PBRER
This is the webinar your entire Pharmacovigilance team cannot afford to miss.
Who Should Attend?
Professionals involved in:
     • Drug Safety and Pharmacovigilance
     • Regulatory Affairs
     • Clinical Development
     • Benefit-risk Management
• Executives (Including C-Level) with Any Legal
   Responsibility for Drug Safety
• Market Access
• Post-approval Studies
Did You Know?
You can receive 1 elective unit towards your Clinical Safety and Pharmacovigilance Certificate by attending this webinar.
April 18 | 11:00AM-12:30PM ET
April 24 | 11:00AM-12:30PM ET
April 30 | 12:30-2:00PM ET

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