Publications and Online Training
Principles of the General Data Protection Regulation, online training, 2018. www.brookwood4dataprotection.eu
Guide to Data Protection, The EU general Data Protection, 2018, Canary Ltd.
Essential Pharmacovigilance, handbook in PV, 2018, Canary Ltd. www.canarybooks.com
PV for ALL, online safety reporting training, Brookwood Academy, 2017. www.brookwoodtraining-online.net
Know PV, online training in what pharmacovigilance is all about, Brookwood Academy, 2017.
PV for Local Safety Contacts and QPPVs, online pharmacovigilance training, Brookwood Academy, 2017
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
PATENTS:
EP1011673: Novel NIDDM Regimen
EP0776217: A method of preventing or reducing the formation of Factor VIII inhibitory antibodies in patients with Haemophilia A.