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Latest report July 2025

Safety Observer 224

A new draft of the EU Variations Guideline has been published, which will apply from 15-Jan-2026.

Released 08-Jul-2025

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Clear

Past Reports

Safety Observer 223

CIOMS Working Group XII issues Final Report on Benefit-Risk Balance..

Safety Observer 222

The EMA has corrected the guidance regarding the reporting of non-compliance issues with pharmacovigilance obligations..

Safety Observer 221

The EMA has updated the information on reporting of non-compliance issues..

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November 30, 2023

Time for change !!

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May 4, 2023

Reform of EU Pharmaceutical Legislation

By Thierry Hamard

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EU-QPPV, Director of a Nordic-based pharmaceutical company 15-July-2022
Safety Observer serves as our company’s primary source for Regulatory PV updates.
All PV employees have access and the comprehensive content in each issue is discussed on a monthly “Safety Observer Meeting”.

EU-QPPV at a US-based biotech 30-June-2022
The Regulatory Intelligence Reports received monthly allow us to be more efficient in our regulatory monitoring
The reports contain all the information necessary to meet our requirements. The summaries and links contained for each item make it a clear and practical document, allowing us to save a lot of time.

Expanscience Laboratoires 30-June-2022
Our Safety Observer monthly review is part of our company’s safety specific Regulatory Watch process to ensure that changes in the regulatory landscape are captured and internal SOPs updated accordingly

Lisa Skintemo, Pharmacovigilance Director at a small European-based Biotech company 01-July-2022
For five years now I have been reading the Safety Observer and will continue to do so.
Even newsletters from large Pharmaceutical Associations cannot rival the in-depth coverage of such a long list of salient PV topics, as does the Safety Observer. The information contained is up-to-date, relevant to all decision makers in PV – and presented in a no-nonsense style that does not need precious time to understand the changes made: Succinct and relevant.

Dr. Renald Hennig, Managing Director at SCRATCH Pharmacovigilance GmbH & Co. KG (and EU QPPV for a number of clients) 04-July-2022
As one of its earliest subscribers, I can testify of the high level of completeness and quality of this regulatory screening.
Each month, it provides in one look all the necessary updates I require to perform my daily activities.

Local Drug Safety and Medical Information Manager of the French Affiliate of an EU-based Pharmaceutical company 04-July-2022
I have discovered Safety Observer in 2016 and since then I am the most loyal fan of it.
This magazine is able to replace the entire regulatory intelligence department in your organization. Subscription to Safety Observer is the easiest and most efficient way to keep up with the speed of safety regulation changes on a global level

Associate Director of Medical Affairs, middle size CRO 11-July-2022
Subscribing to the Safety Observer has given me relevant updates in a concise, accurate and easy manner in order to be kept up to date in my day to day Quality Assurance activities internally and externally.
The format has enabled easy understanding and the accessibility to the source document has made it easier to document my self training. I am extremely pleased with the service provided.

Associate Director at a Global QA Service Provider 30-June-2022
Safety Observer is an effective and essential link in our regulatory intelligence,
particularly in the constantly changing clinical research environment

S.Laghouati, Head of the Pharmacovigilance Unit, Clinical Research Division, Gustave Roussy 18-July-2022
Safety Observer has proven to us to be a reliable and reputable resource allowing us to remain current on new regulatory guidance.
Safety Observer has also been instrumental in alerting us to crucial Drug Safety Signal Detection publications and literature, which have had a direct impact on improving and bolstering the attentiveness of our pharmacovigilance activities.

Synergy Research, Inc 01-August-2022

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Regulatory Intelligence,
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New reading platform

Safety Observer 224

Past Reports

Free alerts

Latest news

The New Pricing

Browser Privacy settings

The new Reading Platform !!

Time for change !!

Reform of EU Pharmaceutical Legislation

Let’s hear
What they say

For many years, my company has subscribed to Safety Observer

Safety Observer serves as our company’s primary source for Regulatory PV updates.

The Regulatory Intelligence Reports received monthly allow us to be more efficient in our regulatory monitoring

Our Safety Observer monthly review is part of our company’s safety specific Regulatory Watch process to ensure that changes in the regulatory landscape are captured and internal SOPs updated accordingly

For five years now I have been reading the Safety Observer and will continue to do so.

As one of its earliest subscribers, I can testify of the high level of completeness and quality of this regulatory screening.

I have discovered Safety Observer in 2016 and since then I am the most loyal fan of it.

Subscribing to the Safety Observer has given me relevant updates in a concise, accurate and easy manner in order to be kept up to date in my day to day Quality Assurance activities internally and externally.

Safety Observer is an effective and essential link in our regulatory intelligence,

Safety Observer has proven to us to be a reliable and reputable resource allowing us to remain current on new regulatory guidance.

Supporting the global Pharmacovigilance community since 2005

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Regulatory Intelligence, at your fingertips

New reading platform

Safety Observer 224

Past Reports

Free alerts

Latest news

The New Pricing

Browser Privacy settings

The new Reading Platform !!

Time for change !!

Reform of EU Pharmaceutical Legislation

Let’s hearWhat they say

For many years, my company has subscribed to Safety Observer

Safety Observer serves as our company’s primary source for Regulatory PV updates.

The Regulatory Intelligence Reports received monthly allow us to be more efficient in our regulatory monitoring

Our Safety Observer monthly review is part of our company’s safety specific Regulatory Watch process to ensure that changes in the regulatory landscape are captured and internal SOPs updated accordingly

For five years now I have been reading the Safety Observer and will continue to do so.

As one of its earliest subscribers, I can testify of the high level of completeness and quality of this regulatory screening.

I have discovered Safety Observer in 2016 and since then I am the most loyal fan of it.

Subscribing to the Safety Observer has given me relevant updates in a concise, accurate and easy manner in order to be kept up to date in my day to day Quality Assurance activities internally and externally.

Safety Observer is an effective and essential link in our regulatory intelligence,

Safety Observer has proven to us to be a reliable and reputable resource allowing us to remain current on new regulatory guidance.

Supporting the global Pharmacovigilance community since 2005

Sign up for alerts

Register today!

Close

3-Month Plan

Starts at 180 €

1-Year Plan

Starts at 600 €

Stay in the loop

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