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Latest report   November 2022

Safety Observer 194

ICH E19 Guideline on optimization of Safety Data Collection finalised and subsequently adopted by EMA for Europe.

Released 08-Nov-2022

Pages 36
Highlights

Past Reports

Safety Observer 193
The FDA has published the final guidance on RWD and RWE Documents Submissions for Drugs and Biological Products.
Clear
Highlights
Safety Observer 192
A new FDA draft guidance explains how generic sponsors will be able to submit electronic Safety Reports to FAERS.
Clear
Highlights
Safety Observer 191
The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies.
Clear
Highlights

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  • For many years, my company has subscribed to Safety Observer

    It is a very valuable and structured tool. It is keeping us up to date with new and updated regulatory requirements so we can take appropriate actions to ensure compliance.
    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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