Advanced Pharmacovigilance

Management Forum

Course

In The Rembrandt Hotel, London

£ 1,799 + VAT

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Description

  • Type

    Practical seminar

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    1 Day

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

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

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Reviews

Subjects

  • Risk
  • Compliance
  • Risk Management
  • Global
  • IT risk
  • Regulations
  • Pharmacovigilance
  • Pharma
  • Management
  • Life Science

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

  • Audits and expectations – risk-based inspections
  • Compliance and drug safety
  • Overview of the PSMF in the EU
  • Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
  • Safety reporting in licensing agreements
  • Developing Company Core Safety Information (CCSI) – CIOMS III
  • PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
  • Implications for safety reporting in global clinical trials n Risk/benefit determinations
  • Risk Management Plans (RMPs)

See related categories

Advanced Pharmacovigilance

£ 1,799 + VAT

The best Chemistry courses

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