Important
Updates on New European Pharmacovigilance Requirements
Presenters:
• 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?
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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:
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• Drug Safety
and Pharmacovigilance
• Regulatory Affairs
• Clinical Development
• Benefit-risk Management
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• Executives (Including C-Level) with Any Legal
Responsibility for Drug Safety
• Market Access
• Post-approval Studies
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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
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April
24 | 11:00AM-12:30PM ET
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April
30 | 12:30-2:00PM ET
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