Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
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To ensure Regulatory compliance to the new Pharmacovigilance system introduced in the EU in 2012 and its evolution. The topics cover the details behind the legislation in Regulations 2010/84 & 1235/2010 and the detail within the new Pharmacovigilance Modules

Areas Covered in the Session

  • Expedited reporting
  • Risk Management Systems
  • Inspections
  • Quality Management
  • The EU QP for Pharmacovigilance
  • The Pharmacovigilance Systems Master File
  • Signal Management and the role of the Pharmacovigilance Risk Assessment Committee
  • EU Regulatory Inspection

Who Will Benefit

Anyone working in the following areas:

  • Drug Safety/Pharmacovigilance
  • Clinical Personnel
  • Drug Safety Administrators
  • Quality Assurance and Auditors
  • Regulatory Personnel


Day 1 Schedule

Lecture 1: The Legislation Outline for 1235/2010 & 2010/84

  • Impact on previous legislation
  • Enforcement of new legislation
  • Purpose of the new legislation and its focus
  • Updates since 2012

Lecture 2: The Impact on ICSR Safety Reporting in Europe (Module VI)

  • Changes to expedited reporting
  • Compliance monitoring
  • Regulatory Quality Assessments - what and why
  • The EU Product Dictionary Database - XEVMPD
  • Electronic versus paper reporting - immediate changes and proposed

Lecture 3: Guideline on Risk Minimization Measures (Module XVI)

  • Requirements for monitoring and testing
  • Risk minimization practices
  • Updates to the tools

Lecture 4: PSURs/PBRERs - An Overview (Module VII)

  • Changes for EU PSUR submissions
  • Revision of PSUR timelines
  • Changes in the format of the PSUR – ICH E2C (R2)
  • EU PSURs v rest of world
  • The PSUR and Risk Management Plans

Lecture 5: The New Legislation and Quality Management (QM) (Module I)

  • QC, QA and QM
  • The purpose of QM
  • Requirements of QM and examples of QM activities
  • The responsibilities of the license holder and QM

Lecture 6: The PV Master File - PSMF (Module II)

  • The PV Master File - purpose and maintenance
  • Master File Annexes and Log book
  • Control of the PSMF
  • Inspection readiness and the PSMF

Day 2 Schedule

Lecture 7: Signal Detection Activities (Module IX)

  • The EMA and Signal Detection incl EV8
  • Requirements from the MAH and Signal Detection
  • Signal Detection and the internet
  • Signal Detection and RMPs

Lecture 8: Continuous pharmacovigilance, ongoing benefit-risk evaluation (Module XII)

  • Benefit-Risk Assessments
  • Regulatory action
  • RMPs
  • Planning of public communication

Lecture 9: Products with Additional Monitoring & Safety Communication (Modules X & XV)

  • ADR reporting and labelling, Events Of Special Interest
  • RMPs and Labelling
  • Medical information and RMPs
  • Internal and external communication of new product safety issues

Lecture 10: Pharmacovigilance Audits (Module III)

  • Format of the audit
  • Risk based approach to audits
  • Audit findings and Corrective Actions (CAPA)
  • Audits and the Pharmacovigilance Master File

Lecture 11: Risk Based Inspections (Module IV)

  • The Inspection format
  • The Inspection risk assessment
  • Inspection scope
  • Inspection findings
  • Regulatory actions
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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Graeme Ladds 

PharSafer Associates Ltd

Dr. Graeme Ladds has been involved in Drug Safety for the last 30 years. Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 15 years for PharSafer. His previous role in industry was Head of Global Drug Safety at Shire Pharmaceuticals.

Fifteen years ago, Graeme set up his own consulting Company PharSafer Associates Ltd, a niche CRO providing both Clinical and post marketing drug safety and medical information services to the Pharma industry globally, from total outsourcing of Safety and Medical Services to bespoke projects and interim requirements. Based in the UK, the Company performs full safety services for companies from the USA, Canada, India, Europe and Japan and has been inspected on site by the Regulators and clients. PharSafer employs science graduates, pharmacists, physicians all with varied and extensive pharmacovigilance experience.


Location: Zurich, Switzerland
Hotel: Hilton Zurich Airport