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Pharmacovigilance is a key part of the core business of every pharmaceutical company. Their business depends upon, and their responsibility is to, ensuring patients in need have optimal access to the right medicines, that use in the wrong patients is avoided as much as possible, through optimizing the benefit risk balance of their products. To…

Read More Pharmacovigilance: A primary business processes for pharmaceutical companies
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I have 20 years experience at the national and European level in pharmacovigilance within regulatory authority and industry. I am currently available for short term, interim or permanent positions in Netherlands, Belgium, Germany, Switzerland or the UK (and in consultation of course also elsewhere in Europe) as Qualified Person for Pharmacovigilance (QPPV), as global safety…

Read More Senior medical advisor pharmacovigilance available / Senior medisch adviseur pharmacovigilantie beschikbaar
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It took a bit of time, but after an unanticipated computer failure perspektivo.nl is up again under updated software. The prolonged transition was due to the fact that the old software was outdated and no longer supported. Thus testing of various alternatives was needed. This resulted in a choice for a single underlying content management…

Read More Perspektivo.NL website is up again after computer failure and switch to a new environment
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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…

Read More Pharmacovigilance training
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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…

Read More Pharmacovigilance audits
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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…

Read More Writing or reviewing European Risk Management Plans
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As of 1 March 2010 Perspektivo pharmacovilance is open. We can provide general pharmacovigilance consultancy services, pharmacovigilance training, aggregate report writing, audit and inspection preparation, and issue management support. A short CV of Arthur P. Meiners, owner of Perspektivo and Perspektivo-Aerfoto can be found here on LinkedIn: http://www.linkedin.com/profile?viewProfile=&key=42798337 Of course Perspektivo-Aerfoto continues to be a…

Read More Perspektivo pharmacovigilance consulting services open
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De Naam Perspektivo komt uit het Esperanto en betekent perspektief, maar heeft ook een PV (PerspektiVo) klank, symbolisch duidend op PharmacoVigilantie. Perspektivo-Aerfoto, een tweede bedrijfs-naam, betekent luchtfoto perspektief, wat zeker duidt op een ander perspektief. De reden om te kiezen voor Esperanto is eenvoudig: we zochten een naam die en makkelijk te onthouden was, makkelijk…

Read More De naam Perspektivo en het logo / The name Perspektivo and the logo