Publications and Online Training

Principles of the General Data Protection Regulation, online training, 2018.  www.brookwood4dataprotection.eu  

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Guide to Data Protection, The EU general Data Protection, 2018, Canary Ltd. 

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Essential Pharmacovigilance, handbook in PV, 2018, Canary Ltd. www.canarybooks.com 

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PV for ALL, online safety reporting training, Brookwood Academy, 2017. www.brookwoodtraining-online.net 

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Know PV, online training in what pharmacovigilance is all about, Brookwood Academy, 2017.

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PV for Local Safety Contacts and QPPVs, online pharmacovigilance training, Brookwood Academy, 2017

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QA expectations for pharmacovigilance in post-authorisation safety studies, CRAdvisor and CQAdvisor, 2012 - on the challenges of increasing expectations for PAS

New Trends in Pharmacovigilance, RAJ, September 2008 – on the emerging challenges for drug safety surveillance.

Drug Safety in Partnerships, CRAdvisor and CQAdvisor, 2008 – on the challenges in partnerships with shared pharmacovigilance obligations.

Pharmacovigilance Inspections, CRAdvisor and CQAdvisor, 2004 – on the first EU (UK MHRA) inspection of pharmacovigilance systems.

Users Guide to Computer Validation, Canary Publications, 2002 –handbook on how to handle validation of regulated e- systems

Japanese inspectors visit Europe, 1998. The Monitor, and CQA Advisor – article on the first GCP inspection in Europe done by Japanese Health Authorities

Adapting to a changing environment, Pharmavision 1995 – article on EU legislation challenges in plasma products registration

Doing Trials to ICH GCP with Glaxo, 1991– booklet on GCP for investigators, used in international trial programs

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PATENTS:

EP1011673: Novel NIDDM Regimen

EP0776217: A method of preventing or reducing the formation of Factor VIII inhibitory antibodies in patients with Haemophilia A.