Advanced Pharmacovigilance

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing

25-27 Mar 2019

& 25-27 Sep 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course overview

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.


  • 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

Who should attend

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

Programme - Day one

09.00 Registration and Coffee

09.30 Start of meeting

Due Diligence

  • Due Diligence on products, companies (partners & acquisitions)
  • Due Diligence involvement – team composition
  • Safety information requirements for Due Diligence
  • Review of safety data (Clinical and Post Marketing)
  • Defining risk in Due Diligence appraisals

Training for Drug Safety Reporting Duties

  • Regulations concerning safety training
  • Who trains whom and when?
  • Training versus job description
  • Training records, maintenance and updates
  • Role of QA and HR in training

Audits and Expectations

  • Regulatory expectations in Pharmacovigilance Audits (risk-based inspections)
  • Preparation for the Audit
  • Records to be available at the Audit
  • Audit findings and recommendations

Compliance and Drug Safety

  • Basic principles – what will the Regulators want to see?
  • Measuring compliance
  • Quality versus quantity in safety reports
  • Future aspects in ensuring efficient compliance
  • Quality Management under the new EU legislation

The PV Master File and the DDPS

  • The PV Master File
  • The PV Master File – purpose and maintenance
  • The DDPS – What happens now
  • Transition from DDPS to PV Master File

Interactive Exercise: Designing the Requirements for a Safety Department and Drug Safety

17.00 Close of day one

Programme - Day two

09.00 Start of day two

Product Safety Reviews – Purpose & Function

  • The Safety Review Committee
  • What to look for in signal evaluation under new EU guidance
  • Timings for Safety Review in clinical and post marketed products
  • Record keeping for Safety Review meetings
  • Serious safety findings – crisis management following new safety findings

INTERACTIVE EXERCISE: Designing the Requirements for a Safety Review Group

Safety Reporting in Licensing Agreements

  • What types of Licensing Agreements exist?
  • What are the EU & FDA Regulations concerning licensing agreements?
  • Audits of pharmacovigilance capabilities in licensing partners
  • What agreements need to be in place for safety reporting?
  • Safety reporting agreements – what needs to be covered?
  • Monitoring safety agreements – what happens if it goes wrong?

Developing Company Core Safety Information – CIOMS III

  • CIOMS III & Core Safety Information
  • Developmental Core Safety Information (DCSI)
  • How to determine what to include, what to exclude in DCSI/CCSI
  • Are there differences in EU and FDA?
  • Determinations of inclusion in CCSI
  • Maintenance & development of CCSI

INTERACTIVE EXERCISE: Deciding whether New Safety Data presented from a Clinical Trial should be put into Core Safety Information

PSURs and the New Revisions in ICH E2C

  • Timing for PSURs
  • PSUR Content – and new format
  • Late breaking information and PSUR extensions
  • The DSUR

17.00 Close of day two

Programme - Day three

09.00 Start of day three

The EU Clinical Trials Directive

  • The Principles of the Directive
  • Implications for safety reporting in global clinical trials
  • The SUSAR Database
  • The EUDRACT Database

Risk/Benefit Determinations

  • Definitions of risk/benefit – FDA and EU perspective (including the new 2012 legislation)
  • Risk/benefit assessments – who does this and where does the information go?
  • Safety Assessments and risk/benefit – frequency and reporting
  • Changes in risk/benefit – how to manage and review existing profiles

INTERACTIVE EXERCISE: Reviewing the Safety of a Product

Risk Management Plans (including new EU requirements 2012)

  • Purpose
  • Content
  • Monitoring and updating the RMP
  • Reporting the RMP

Crisis Management within Drug Safety

  • Regulations & Guidelines in connection with serious safety issues
  • What determines a crisis?
  • Communications to Regulators – what is required
  • Communications within the company
  • What happens next?

Interactive Exercise: Deciding how to Handle a Major Crisis within the Company

Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.

16.30 Close of day three


Graeme Ladds (25-27 Mar 2019)

Graeme Ladds, Director of PharSafer, has over 30 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. He 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.

Book now

25-27 Mar 2019
25-27 Mar 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
25-27 Sep 2019
25-27 Sep 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AGA AB
  • Alfa Wassermann S.p.A.
  • Amgros
  • Astellas Pharma A/S
  • Auden McKenzie Group
  • Bayer Pharma AG
  • Belupo d.d.
  • Chanelle Medical
  • Dexcel Pharma Limited
  • Eisai Limited
  • Ferring Pharmaceuticals A/S
  • Grunenthal GmbH
  • Jenson R+ Ltd
  • Kowa Research Europe Ltd
  • Kyowa Kirin International plc.
  • Liverpool School of Tropical Medicine
  • Merck Serono
  • Merck Serono Ltd
  • Nycomed UK Limited
  • Pfizer Gulf FZ LLC
  • Piramal Healthcare Ltd
  • Pliva Croatia Ltd
  • Procter & Gamble Technical Centres Ltd
  • Regional QC Laboratory
  • Solvay Pharmaceuticals
  • UCB Pharma SA
  • Valeant
  • Voyage Tour LLC
  • Winthrop Pharmaceuticals UK Ltd

A PV overview in three days, that's nice.

Tina Pank Vase, Associate Professional, LEO Pharma A/S

A very knowledgeable and experienced speaker always ready to answer all the questions and give real-life examples.

Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello

The course was thorough and the manual a good resource to refer back to. The speaker had a very engaging presentation style and freely answered questions and shared real-word examples and inspection expectations.

Katy Blake, PV Specialist , Dexcel Pharma Limited

Content, presentation and speaker were just great.

Wendy Kleijberg, QPPV, Baggerman Farma Consult

I have understood better from where some regulations come from(Cions). Graeme is a great lecturer who managed to keep the 3 days always dynamic and live

Faouria Dervisagic, Drug Safety Associate, Idorsia Pharmaceuticals Ltd

Excellent course - taught me from A to Z about PV. Content well coordinated to capture audience with different levels of PV experience. Excellent speaker. Highly recommended.

Suna Horner, Associate Medical Manager, HRA Pharma UK & IE Ltd.

Amazing for continuing to develop skills in PV to keep up with the regulatory expectations

Maria Calvo Subirats, GCP&GVP Responsible (QA Unit), Ferrer Internacional

This course provides a great opportunity to gain understanding of latest updated on the PV regulatory requirements and the expectation from regulatory inspectorate.

Maria Calvo Subirats, GCP&GVP Responsible (QA Unit), Ferrer Internacional

It covers a lot of subjects, it was a complete course regarding activities in Pharmacovigilance. Presentation and speakers were really clean.

Gwladys Becuwe, Durg Safety Officier Junior, Anticipsante

Very good speaker

Nicolas Vauche, Drug Safety Officer, AnticipSante

Was great, will support my work

Anette Wolfmeyer, Deputy QPPV (Qualified Person for Pharmacovigilance), Bayer Animal Health GmbH

Graeme is clearly a PV Expert. The content of training gave a very good overview of all aspects of PV. Finally, a course that you can use in your daily work-life.

Thea Ellermann Petersen, Senior Pharmacovigilance Specialist, LEO Pharma

Good content and put into real life context

Tony Rigden, Head Of Regulatory & Pharmacovigilance, Chiesi UK LTD

Very interesting and interactive course. Good training material and a competent trainer

Francesca Romana Borgia, PV QA Specialist & Auditor, Chiesi


Olga Orlova, PV Process Manager, Bayer, JSC


Mona Bjørkmo, Pharmacovigilance Scientist, GE Healthcare AS

Very experienced in many areas relevant for PV. Good examples. Open for questions and discussions.

Ingvild Haugen, PV Scientist, GE Healthcare

Very good (advanced) course

Peter Kohut, PV Specialist, Ewopharma International, s.r.o.

Very good speaker with a wealth of knowledge. Good examples and real life stories. Would like other activities rather than pure listening.

Lisa Courtier, Drug Safety Officer, JensonR+ Limited

Overall a very positive experience, the course covers very current and relevant topics, is well organised and presenter is an engaging speaker

Rita Bildøy, PV Compliance and Training Expert, Ge Healthcare Lifesciences

Content - highly relevant to my position. Presentation - enough detail and to the point. Speaker - very knowledgeable and engaging

Saha Jasarevic, Global Pharmacovigilance Scientist, GE Healthcare AS

Trainer is excellent

Murugan Addepalli, Senior Research Scientist, Sun Pharmaceutical Industries Ltd

I am really happy with all of it

Jelena Rebernisak, TPC Operations Coordinator, Pliva Croatia Ltd.

Really beneficial -Graeme is the best

Trine Allerslev, Senior Pharmacovigialnce Specialist, LEO Pharma

More examples would be very helpful.

Jung Hyun Byun, PV Associate, Dong-A ST Co.,Ltd