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 Sep 2019

& 25-27 Mar 2020 , 23-25 Sep 2020

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

Book now

Course overview

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

Key topics to be addressed:

  • 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)

Benefits of attending:

  • 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 inspections
  • Discuss the implications of Brexit

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

Due Diligence

  • Due Diligence on products, companies (partners and 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/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 System Master File (PSMF)

  • The PSMF – purpose and maintenance
  • The PSMF annexes
  • The PSMF and audits

Interactive exercise: The requirements for a safety department

Programme - Day two

Product safety reviews – purpose and function

  • The Safety Review Committee (SRC)
  • What to look for in signal evaluation under latest 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 and 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 (CCSI) – CIOMS III

  • Developmental core safety information (DCSI)
  • How to determine what to include and what to exclude in DCSI/CCSI
  • Are there differences in EU and FDA?
  • Maintenance and development of CCSI

Interactive exercise: Should new safety data from a clinical trial be put into core safety information?
PSURs and the revisions in ICH E2C

  • Timing for PSURs
  • PSUR content and latest format
  • Late breaking information and PSUR extensions
  • The DSUR

Programme - 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
  • The new EU Clinical Trial Regulation

Risk/benefit determinations

  • Definitions of risk/benefit – FDA and EU perspective
  • 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 and risk/benefit of a product
Risk Management Plans (RMPs)

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

Crisis management within drug safety

  • Regulations and 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.


Graeme Ladds (25-27 Sep 2019, 25-27 Mar 2020)

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 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
25-27 Mar 2020
25-27 Mar 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
23-25 Sep 2020
23-25 Sep 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Blue Earth Diagnostics
  • CareFusion
  • Dexcel Pharma Limited
  • Eisai Limited
  • Genesis Pharma (Cyprus) Ltd
  • GW Pharmaceuticals
  • Icon Clinical Research (UK) Limited
  • Janssen
  • Jenson R+ Ltd
  • Medica SA
  • Medochemie Limited
  • Novartis Pharmaceuticals UK Ltd
  • Pfizer Gulf FZ LLC
  • Pinewood Healthcare Ltd.
  • Productlife Ltd
  • Research and Markets
  • Roche Pharma (Switzerland) Ltd
  • Romastru Trading Srl
  • Rosemont Pharmaceuticals
  • Sanofi Pasteur MSD
  • Sanofi-Aventis SA
  • Solvay Pharmaceuticals
  • Syntaxin Ltd
  • Takeda Development Centre Europe Ltd
  • Takeda UK Limited
  • TEVA
  • VAN Pharma Consult

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

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

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

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

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.

Very good speaker

Nicolas Vauche, Drug Safety Officer, AnticipSante

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

Gwladys Becuwe, Drug Safety Officer, Anticipsante

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

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

Was great, will support my work

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

Content, presentation and speaker were just great.

Wendy Kleijberg, QPPV, Baggerman Farma Consult

Good content and put into real life context

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


Olga Orlova, PV Process Manager, Bayer, JSC

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

Francesca Romana Borgia, PV QA Specialist & Auditor, Chiesi

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

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

Ingvild Haugen, PV Scientist, GE Healthcare


Mona Bjørkmo, Pharmacovigilance Scientist, GE Healthcare AS

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

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

I am really happy with all of it

Jelena Rebernisak, TPC Operations Coordinator, Pliva Croatia Ltd.

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

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

Trainer is excellent

Murugan Addepalli, Senior Research Scientist, Sun Pharmaceutical Industries Ltd