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Latest report November 2024

Safety Observer 216

The FDA has published the final guidance on Neurodevelopmental Safety Studies in Neonates.

Released 06-Nov-2024

Pages 39

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Past Reports

Safety Observer 215

India issues revised Pharmacovigilance Guidance for MAHs..

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Safety Observer 214

EMA issues revised version of GVP Module XVI on Risk Minimisation Measures..

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Safety Observer 213

ICH issued a revised Reflection Paper on RWD and RWE harmonisation..

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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
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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

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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.

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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
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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.

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Regulatory Intelligence,
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New reading platform

Safety Observer 216

Past Reports

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Latest news

Time for change !!

Browser Privacy settings

The new Reading Platform !!

Reform of EU Pharmaceutical Legislation

PhV Inspections: What’s New ?

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 216

Past Reports

Free alerts

Latest news

Time for change !!

Browser Privacy settings

The new Reading Platform !!

Reform of EU Pharmaceutical Legislation

PhV Inspections: What’s New ?

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 €

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Starts at 600 €

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