Articles

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DOA gets closer! What does it mean? What changes? The requirements for clinical evaluation applies also for Class I Medical Devices. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the

The pharmaceutical industry is facing several changes that will challenge the skills of us experts. The Medicines Verification System was introduced in February, and Brexit, the separation of Great Britain from the European Union, will give us a lot to

NOTE! The event is conducted in Finnish. OHJELMA 8:30   Hyvän Olon aamiainen 9:00   Tervetuloa! 9:10   Kokemuksia lääkevarmennusjärjestelmän käyttöönotosta   Lääkevarmennus eri apteekkijärjestelmissä. Miltä hälytykset näyttävät ? Kehittämispäällik

Summer holiday season is nearby. We would kindly remind you that we are available the whole summer season and our back-up system is in place. To ensure fluent and smooth information flow during holiday season, please use our common mailboxes whenever a

NOTE! The event is conducted in Finnish. OHJELMA Klo 8:30  Hyvä olon aaminen Klo 9:00  Tervetuloa! Kuinka markkinoille saattamisen jälkeinen seuranta ja kliininen arviointi nivoutuvat yhteen? Miten lääkinnällisten laitteiden MDD:n mukaisia CE-sertifika

  NOTE! The event is conducted in Finnish. OHJELMA 8:30 Hyvän Olon aamiainen 9:00 Tervetuloa! 9:10 Keskusteluaamun aiheet Viimeisimmät kokemukset lääketurvatarkastuksista Kokemuksia lääketurvatarkastuksen sisällöstä myyntiluvan haltijan   näkökulm

According to the bulletin published on 8 November 2018 by the Finnish Medicines Agency Fimea, the summaries of product characteristics (SmPCs) of both human and veterinary medicines shall in the future be provided also in Swedish. This change is a part

EMA’s and HMA’s representatives brought interesting thoughts about the future priorities and presented the common strategy for European medicines regulatory network to 2020. The key priorities and challenges in addition to the global situation were sub

You are warmly welcome to Medical Device discussion event at Biocodex on 1st of November.   Topic of the event: New EU Regulation of Medical Devices – What do these changes mean and how will they affect your company? WHERE| Biocodex Oy, Trio-talo.

You are warmly welcome to Medical Information discussion event at Biocodex on 6th of November.   Topic of the event: How should GDPR be considered in the company’s medical information tasks? How to develop pharmaceutical information services suppo

In this issue we’ll take a step towards autumn. PHAME will provide inspiring and interesting trainings also during this autumn. Stay tuned and check the preliminary info of the trainings from PHAME newsletter.   You can subscribe our newsletter by

You are warmly welcome to a whole-day seminar organized by our excellent experts in Good distribution practice (GDP) and Pharmacovigilance / Regulatory Affairs (PV/RA). Time: Tuesday 4th of September from 9.30 until 16.00 Location: Park Inn by Radisson

You are warmly welcome to a whole-day seminar organized by our excellent experts in Good distribution practice (GDP) and Pharmacovigilance / Regulatory Affairs (PV/RA). Time: Tuesday 4th of September from 9.30 until 16.00 Location: Park Inn by Radisson

What is data integrity in Pharmaceutical industry? Learn this and many more from the latest summer issue of PHAME newsletter. Stay updated and subscribe PHAME newsletter from our website Next PHAME newsletter will be published on August. In the meanwhi