Safety Observer

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Latest report   September 2023

Safety Observer 203

The Australian TGA sets new requirements for the reporting of Safety Issues.

Released 07-Sep-2023

Pages 44

Past Reports

CIOMS has published the draft report of Working Group XII on Benefit-Risk Assessment..
The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) has entered the public consultation period..
The European Commission published proposals for the largest reform of the pharmaceutical legislation in over 20 years..

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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
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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

    Lisa Skintemo, Pharmacovigilance Director at a small European-based Biotech company 01-July-2022
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    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
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    Local Drug Safety and Medical Information Manager of the French Affiliate of an EU-based Pharmaceutical company 04-July-2022
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    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.  

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    Synergy Research, Inc 01-August-2022

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