Comprehensive Practical Review of the EU Pharmacovigilance Modules

The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments – not just Pharmacovigilance but also including Clinical; Medical Information; Marketing; IT; Quality; Regulatory; Training and GMP.

In-house Training and Consultancy Services

Running this In-house programme will help your team:

  • Gain an invaluable overview of the new European PV legislation and How the 15 modules Link Together
  • Discover what key areas of pharmacovigilance activities have been affected
  • Understand the impact of the legislation and what you will need to do to implement in your company
  • Discuss the enforcement of the legislation and what the regulators will expect to see at inspection time
  • See what NEW company departments are affected Under the wew legislation
  • Follow the changes that have happened in the modules since 2012

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample Programme - Day One

Quality Management – the Requirements

  • QC, QA and Quality Management
  • What to monitor
    • The legislation
    • The activities
    • Root Cause Analyses, Corrective Action Plans
  • QMS and the Company

The PSMF

  • Writing and Maintaining the PSMF
  • Updates to the Annexe
  • Routine PSMF Assessments
  • Quality Assessments of the PSMF

Internal Audits

  • Scheduling Audits
  • Risk Based Audits
  • Maintenance of Audit findings
  • Audit closures

Regulatory Inspections

  • Types of Inspections
  • Preparation for Inspections
  • Inspection findings
  • Management of Inspection findings

Safety Reporting in the EU

  • What needs to be reported
  • Country specific requirements
  • Literature articles and safety reporting
  • Special situations

Sample Programme - Day Two

Safety Reviews and Signals Detection

  • The frequency of Safety Reviews
  • What is included in safety reviews
  • Management of potential signals

Risk Management Plans

  • ICHE2E – Risk Management Plans
  • What products require RMPs in the EU
  • What to include in RMPs
  • Updates to RMPs

Risk Benefit Analyses

  • CIOMS IV
  • EU risk Assessments by product
  • USA assessments of benefit risk
  • The Risk Benefit Analysis

PSURS/PBRERs in the EU

  • ICH E2C – R2
  • The EU position of timing of PBRERs
  • Member State responsibilities for PBRERs

Additional Monitoring

  • The EU criteria for additional monitoring
  • Requirements for Black Triangle Products
  • Managing Black Triangle Products

The Roles and Responsibilities of the MAH

  • The role of Company Directors
  • The role of the EU QP PV
  • The responsibilities of Upper Management for the new EU legislation

Recommended Trainer

Graeme Ladds, the Director of PharSafer, has over 26 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. Graeme then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

Previous customers include...

  • Actelion Pharmaceuticals Ltd.
  • Bristows LLP
  • CHIESI FARMACEUTICI S P A
  • Dr Reddy's Laboratories Ltd
  • F. Hoffmann-La Roche Ltd
  • Ferrer Internacional, S.A.
  • Genethics Regulatory Services
  • Genethics Regulatory Services Ltd
  • Iggea Ltd
  • Pliva Croatia
  • Reinstein Associates
  • Roche Products Limited