Advanced Pharmacovigilance

Management Forum

Course

In The Rembrandt Hotel, London

£ 1,849 + VAT

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Description

  • Type

    Practical seminar

  • Level

    Advanced

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    3 Days

This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.
KEY TOPICS TO BE COVERED
Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
The DDPS retirement and the New PV Master file in the EU
Compliance and Drug Safety
Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
Developing Company Core System Information CIOMS III
Safety Reporting in Licensing Agreements
PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
Implications for Safety Reporting in Global Clinical Trials
Risk/Benefit Determinations
Risk Management Plans

Facilities

Location

Start date

The Rembrandt Hotel, London (London)
See map

Start date

On request

About this course

Expand your global safety knowledge
Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
Help ensure you build and maintain a quality Pharmacovigilance department ready for any Pharmacovigilance inspection
Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection

This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena including QA for auditing. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines

At least 2 years worth of knowledge in Drug Safety.

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Reviews

Subjects

  • Risk
  • Compliance
  • Risk Management
  • Global
  • IT risk
  • Regulations
  • Pharmacovigilance
  • Pharma
  • Training
  • Management

Teachers and trainers (1)

Graeme Ladds

Graeme Ladds

Director, PharSafer

Course programme

This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.

KEY TOPICS TO BE COVERED

  • Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
  • The DDPS retirement and the New PV Master file in the EU
  • Compliance and Drug Safety
  • Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
  • Developing Company Core System Information CIOMS III
  • Safety Reporting in Licensing Agreements
  • PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
  • Implications for Safety Reporting in Global Clinical Trials
  • Risk/Benefit Determinations
  • Risk Management Plans

WHY YOU SHOULD ATTEND
  • Expand your global safety knowledge
  • Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
  • Help ensure you build and maintain a quality Pharmacovigilance department ready for any Pharmacovigilance inspection
  • Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection

See related categories

Advanced Pharmacovigilance

£ 1,849 + VAT

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