In-house & bespoke training:
Vigilance

Our pharmacovigilance training courses have been designed for drug safety professionals and will offer practical advice on key topics and the latest regulatory developments in this increasingly important field.

Pharmacovigilance has undergone a rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with.

We also provide training in vigilance and adverse event management for medical devices and pharmacovigilance for veterinary medicinal products and cosmetics.

 

Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book

A Practical Guide to Producing and Maintaining the PSMF

In-house & bespoke training

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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A Practical Guide to Writing Risk Management Plans (RMPs)

In-house & bespoke training

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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Additional Risk Minimization Measures (aRMMs) and Their Effectiveness

In-house & bespoke training

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

Typically presented by Alina Panourgia (bio)

Typical duration: Half-day days
Pricing from £350 per attendee
Delivery: collaborative classroom

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Advanced Pharmacovigilance

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 3 days
Pricing from £1,350 per attendee
Delivery: collaborative classroom

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Advanced Veterinary Pharmacovigilance

In-house & bespoke training

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit.

Rated by attendees to the public programme

Typically presented by Declan O'Rourke (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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AI in Pharmacovigilance

In-house & bespoke training

In this exciting new course, gain an introduction into the transformative impact of artificial intelligence on drug safety and monitoring.

Rated by attendees to the public programme

Typically presented by Alina Panourgia (bio)

Typical duration: Half-day days
Pricing from £350 per attendee
Delivery: collaborative classroom

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An Essential Overview of Medical Information

In-house & bespoke training

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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An Essential Overview of Pharmacovigilance

In-house & bespoke training

A practical guide to understanding the role of pharmacovigilance.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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Clinical & Post-Marketing Safety

In-house & bespoke training

This two-day course covers international standards for clinical and post-marketing drug safety, including ICH guidelines, adverse event reporting, signal detection, and risk management strategies.

Typically presented by Graeme Ladds (bio)

Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Cosmetovigilance

In-house & bespoke training

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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European Post-Marketing Pharmacovigilance

In-house & bespoke training

This course provides an overview for senior managers of the key post-market pharmacovigilance activities required to further understand the 2012 EU legislation that has undergone over 20 updates in the last 10 years.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 3 days
Pricing from £1,350 per attendee
Delivery: collaborative classroom

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Introduction to Veterinary Pharmacovigilance

In-house & bespoke training

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

Rated by attendees to the public programme

Typically presented by Declan O'Rourke (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Literature Searching in Drug Safety

In-house & bespoke training

This two-day course offers a thorough understanding of literature searching in drug safety, covering regulatory requirements, search criteria, and the interpretation of safety data, while also providing practical assessments to apply knowledge to real-world pharmacovigilance cases.

Typically presented by Graeme Ladds (bio)

Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Molecule to Medicine: An Introduction to Signal Detection

In-house & bespoke training

This course provides a foundation in the critical role of signal detection in ensuring the safety and efficacy of medicines.

Typically presented by Graeme Ladds (bio)

Delivery: collaborative classroom

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Pharmacovigilance Aspects of Licensing Agreements

In-house & bespoke training

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Rated by attendees to the public programme

Typically presented by Joanne Flitcroft (bio) , Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Pharmacovigilance QMS & Inspection Preparation

In-house & bespoke training

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Post-Market Surveillance - Practical Application for Medical Devices and IVDs

In-house & bespoke training

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

Rated by attendees to the public programme

Typically presented by Anne Jury (bio) , Karen Pearson (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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Post-Market Surveillance and Vigilance of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

In-house & bespoke training

Learn the essential regulatory requirements for post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance of digital health technologies, ensuring product safety, compliance, and continued value creation throughout the product lifecycle

Typically presented by Catarina Carrao (bio)

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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Practical Requirements of the Arab Pharmacovigilance Guidelines

In-house & bespoke training

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP)

In-house & bespoke training

A comprehensive comparison between the importance Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) in drug safety.

Typically presented by Alina Panourgia (bio)

Typical duration: Half-day days
Pricing from £350 per attendee
Delivery: collaborative classroom

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Signal Detection and Regulatory Expectations

In-house & bespoke training

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £1,000 per attendee
Delivery: collaborative classroom

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Signal Detection: A Comprehensive Introduction

In-house & bespoke training

A comprehensive introductory guide to signal detection in pharmacovigilance, covering its history, regulations, processes, and safety assessments.

Typically presented by Graeme Ladds (bio)

Pricing from £500 per attendee
Delivery: collaborative classroom

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Understanding Pharmacovigilance Regulations in APAC

In-house & bespoke training

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Rated by attendees to the public programme

Typically presented by Jan Clarise G. Macalalad (bio)
and 6 more leading experts

Typical duration: 1 day
Pricing from £500 per attendee
Delivery: collaborative classroom

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Very competent.

Jesper Bergwik, Regulatory Affairs Associate, Bioglan AB

Loved it. Great content, great presenter/instructor. He was engaging and explained things clearly, answering questions along the way. I particularly liked the way he brought the content to life and gave greater insight through sharing examples of his personal experiences. Great course, would recommend.

Kishori Amatya, PV and MI officer, Jenson R+

EXCELLENT - worth the time and money. I hoped to gain additional knowledge in Pharmacovigilance/show me areas where I may be lacking. I did not want the training to be a waste of time out of the office...[it was] definitely not — I would highly recommend
the speaker and the course. 5/5 overall.

Nicky Höll, Pharmacovigilance Manager, Eurolab (Pty) Ltd

Overall, 5* - Excellent. I learnt a lot of things in detail. Now happily I can implement those with my current job. All the sessions very helpful for me. Excellent speaker, explained very well and in detail for every question.

Vijaya Laxmi-Tunakala, QA Officer, Pharmacare Premium Ltd

I enjoyed the webinar and the content, presentation and speaker was great.

Shelley Browning, Regulatory and PV Manager, Weleda

An excellent webinar, delivered by a very knowledgeable person in an impactful way by great use of analogies and first hand experiences that brought the learning to life. First experience and a very pleasant one.

Lee Gittings, Country Manager, Biofrontera UK Ltd

Very good seminar which covered all important points around the production and maintenance of the PSMF. The speaker was excellent with a profound knowledge of the topic.

Marie-Christine Klös, Global PV Specialist, Boehringer Ingelheim Vetmedica GmbH

The webinar is very good. [I particularly liked] real life examples from audits faced and conducted.

Bharati Perumalla, PV QA Manager, ALPHAMED FORMULATIONS PRIVATE LIMITED

The content, presentation and speaker were very interesting and clear. They will enable me to improve the management and content of the company's vigilance agreements.

Diarra Ndour , , Innothera Corporate Services – Groupe Innothera

[Speaker] has a really large and great experience and knowledge on all areas of PV. Overall good.

Dorte Jensen, QPPV Deputy, 2care4 Generics ApS