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  1. PHAME
30 May 2018

PHAME’s Discussion Event for Pharmacovigilance and Regulatory Affairs

In April, PHAME held a discussion event for pharmacovigilance and regulatory affairs specialists.

Takeda’s senior regulatory affairs manager Terhi Koivumäki gave a presentation about the company core safety information (CCSI) / company core data sheet (CCDS) process from the view of pharmacovigilance and regulatory affairs. PHAME would like to thank Terhi for the excellent presentation and the illustrative real-life examples.

In addition, PHAME’s experts Eveliina Nylund and Kati Leppänen challenged the listeners on the issue of the smoothness of the cooperation between pharmacovigilance and regulatory affairs, and their interfaces. The topics covered were periodic safety updates, product information and marketing authorization permit updates, pharmacovigilance file updates, the risk management plan, and the application of risk minimisation measures to Finnish practices.

Experiences were shared widely among the participants during the discussion. One of the main take-home messages was that people working in pharmacovigilance and regulatory affairs should share their knowledge and keep each other updated on the current affairs.

The participants agreed that it is good to keep the communication channels open between pharmacovigilance and regulatory affairs team, because the communication in the pharmacovigilance and regulatory affairs interface is important for the predictability, as well as for the business in general.

All in all, it was a great pleasure to share experiences together, and to notice how many shared interfaces there are between pharmacovigilance and regulatory affairs.

PHAME´s future discussion events will continue later on in our new premises in Spektri Business Park.

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