The New European pharmacovigilance legislation with Ralph Nies, Astellas Pharma Europe

Next week we will be releasing the Drug Safety Europe e-book, but for now here is a preview of when we spoke to Ralph Nies, Vice President Drug Safety & Pharmacovigilance, Astellas Pharma Europe R&D.

New European pharmacovigilance legislation


How is your company identifying new sources of product safety data with the current intense focus on drug safety & risk management by regulatory agencies?

At our company, we have a policy that all information that might impact the safety profile of our product is forwarded to the PV Department

How will the new European pharmacovigilance legislation shape your company's safety activities and work structure in the next 6 months? And what do you see as the main difficulties?

We have currently a global project ongoing for the implementation of the new EU Legislation, sponsored by the CEO of the company. The main challenge is to ensure cross-functional gathering of safety relevant information in the right format for the PV System Master File. Pharmacovigilance has to be lived by the entire corporation, PV Department is only a steward of Safety


Prof Guido Rasi, the new Executive Director of the EMA, has expressed his support for the idea of staggered approvals (or adaptive licensing) whereby new drugs can make it to the market faster while safety data is being collected. With this in mind, how do you see the role and capabilities of post-marketing monitoring of medicines changing in the near future?

In order to allow this staggered approval there need to be robust systems that allow for risk and benefit evaluation almost real time to ensure that appropriate action to protect patient safety can be taken. Also a scientifically sound and well accepted method to measure benefit-risk balance needs to be established in order to come to an objective outcome

Ralph Nies will be speaking on Legislative requirements for the pharmacovigilance system with focus on the Pharmacovigilance System Master File in September.

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