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 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
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 ten 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.

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 expand their knowledge in pharmacovigilance 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

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
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 content and great detailed presentations.

Michele Power, Global Pharmacovigilance Alliance Manager, Otsuka

Very helpful, practical and of high quality.

Delphine Decrouy, Regulatory affairs Manager, Axience

Great webinar, content and speaker

Janine Gavin, Director, Collaborative Pharma Ltd

The webinar was great!!!

Miguel Angel Ramirez Arredondo, Regulatory Affairs Manager, Sanfer Salud Animal

Informative webinar. Recommend to those wanting to know/validate current industry practices/thinking.

Alesia Mitchell, Associate Director, Global AH PV and RA Quality Standard, Boehringer Ingelheim Animal Health

It was excellent.

María Jesús Bermejo San Román, , Pharma Mar, S.A.

Very detailed and informative.

Antonella Fusco, PV Medical Function, ALFASIGMA SPA

I enjoyed all parts of the webinar. Sharing of information throughout made the webinar engaging.

Alesia Mitchell, Associate Director, Global AH PV and RA Quality Standard, Boehringer Ingelheim Animal Health

Great presentation and I found Declan to be very engaging.

Janine Gavin, Director, Collaborative Pharma Ltd

In general, I was very satisfied with this webinar, I learned a lot.

Jasmina Roca, QPPV deputy, Isdin