July 2013

I am available for organising and presenting onsite or off-site trainings for employees of pharmaceutical companies in Europe on all aspects fo the new pharmacovigilance legislation and guidance, and of course share some 20+ years of pharmacovigilance experience. This training can consist of one to three adjacent training days, or one to five separate training…

Under the new legislation pharmacovigilance systems should be audited regularly. For the regulators a cycle time of 2 years has been specified. It can be expected that inspectors will be looking at a roughly similar audit cycle for parts of or the whole pharmacovigilance system of a pharmaceutical company. I can do pharmacovigilance audits of…

Writing new or updating existing European risk management plans, or even simply reviewing draft risk management plans, is a significant internal resource drain and cost factor for companies. I offer these activities as a service. Assuming the company can provide me with relevant underlying data, such as frequency tables of suspected adverse reactions, recent periodic…