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 £450 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 £450 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 £1,200 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 £800 per attendee
Delivery: collaborative classroom

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An Essential Overview of Medical Information

In-house & bespoke training

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
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 £450 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)

Delivery: collaborative classroom

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European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

In-house & bespoke training

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

Typically presented by Graeme Ladds (bio)

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.

*INCLUDES: Interactive workshop and discussion sessions*

Rated by attendees to the public programme

Typically presented by Declan O'Rourke (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmacovigilance

In-house & bespoke training

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Rated by attendees to the public programme

Typically presented by Shelley Gandhi (bio)
and 3 more leading experts

Typical duration: 3 days
Pricing from £1,200 per attendee
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 £800 per attendee
Delivery: collaborative classroom

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Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

In-house & bespoke training

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

Typically presented by Graeme Ladds (bio)

Typical duration: 3 days
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 £800 per attendee
Delivery: collaborative classroom

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

In-house & bespoke training

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.

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

Typical duration: 1 day
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 £800 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 £800 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.

Typically presented by Param Dayal (bio)
and 4 more leading experts

Typical duration: 6 days
Delivery: collaborative classroom

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Excellent speakers and very experienced.

Joanna Jakubowicz, Deputy QPPV, Ovelle

All of the speakers were absolutely great, the talks were very interesting, informative and on a high level.

Yulia Buberman, PVG , Kamada LTD

The content of the course was comprehensive and the speakers gave a good oral presentation.

Markus Wollenweber, Owner, Wollenweber GMP/GDP-Services

This was a very good course; interesting and relevant content, good presentation and very competent speakers.

Ellinor Eliasson, Senior Quality Consultant, Scandinavian Regulatory Services AB

Yes the trainer was very good! I think that we have received a lot of new information.

Styliani Katsarou, Quality Consultant, Scandinavian Regulatory Services

Excellent speakers, comprehensive explanation, clear understanding... Very much recommendable

Anežka Staňková, SDEA Manager, ZENTIVA

It was very enlightening. The speakers spoke very calmly and with good diction.

Vivian Stefani, PV analyst, Eurofarma Laboratórios

Excellent and engaging content using some 'real life' examples which offered context for greater insight, delivered by an experienced presenter who was able to provide additional depth when further questions were asked.
I thoroughly enjoyed it thank you!

Claire Francis, LRRP and Regulatory Affairs Officer, Vetoquinol UK Ltd

The speakers were both excellent.

Nuria Cabello, PV Manager and QPPV, Farmaprojects SAU

Overall, the speaker was very competent and added a lot of real-world examples and thus enabled better understanding of the theory/regulatory requirements presented. He is an excellent trainer.

Daniela Bausewein, Associate Director Clinical Safety Management, BioNTech SE