Pidämme yhdessä Innokas Medicalin kanssa ilmaisen webinaarin laite-lääke yhdistelmätuotteista ensi viikolla 4.11.2020 klo 13-14. Lue lisää aiheesta ja rekisteröidy webinaariin tästä!
Lääkeyrityksillä on velvollisuus seurata ja valvoa tuotteidensa turvallisuutta ja hyöty-haittasuhdetta yhdessä viranomaisten kanssa. Lääkkeiden haittavaikutusten tai muiden lääkkeisiin liittyvien ongelmien havaitsemista, arviointia, ymmärtämistä ja ehk
Biopankit ovat pankkeja, joihin talletetaan ihmisistä kerättyjä biologisia näytteitä. Näytteet voivat olla esimerkiksi verta, kudospaloja tai ulostetta. Lisäksi biopankkiin tallennetaan myös näytteisiin liittyviä terveystietoja, kuten näytteiden antaja
1800-luvun tiedemiehet tekivät uraauurtavia tutkimuksia, ja joskus löydöksiä jopa sattuman kautta. Modernissa mikrobitutkimuksessa ei luoteta tuuriin. Ranskalainen tiedemies, Louis Pasteur (1822-1895), on yksi kuuluisimpia pioneerejä mikrobiologian ala
The Medical Device Regulation is significantly changing the regulatory framework for medical devices in Europe. One of the new major challenges is the increased focus on post-market surveillance. This forces pharmaceutical companies to be more proactiv
On-site audits can be replaced by well-organized remote auditing. There is a need for frequent auditing in Pharma business. Most of these audits can be carried out remotely. Document reviews and interviews can easily be conducted remotely. When remote
CE marking is an indicator of a medical device’s compliance with EU legislation. CE mark on a medical device is an indication of the manufacturer’s verification that the device complies with all relevant and essential requirements (such as safety and p
Webinars take place every Thursday at 14:00 – 15:00 (EEST) starting from 28th May until 18th June 2020. Why to Join? The purpose of this webinar series is to give oversight of the updated medical device regulation, including the latest updates. To Whom
Tervetuloa keskustelemaan COVID-19 pandemian vaikutuksista lääkkeiden hyviin jakelutapoihin (GDP) Torstaina 14.5.2020 klo 11:00 – 12:00 Toteutustapa: Microsoft Teams webinaari Keskustelutilaisuuden aiheena COVID-19 tilanteen hallinnointi GDP:n
Medical Devices and upcoming new regulations on Thursday 14.5.2020 at 14:00 – 15:00 (GMT+3) Why to Join? The purpose of this webinar series is to give oversight of the updated medical device regulation, including the latest updates. To Whom? This serie
Medical writing requires specific expertise Medical writing involves writing scientific documents of different types, which include but are not limited to, regulatory and research-related documents, drug-related educational and promotional literature,
Medical Device Services draw on Biocodex’s long and extensive experience and leading expertise in pharmaceuticals and medical services. Currently, Biocodex provides expert services to over 130 pharmaceutical companies in the Nordic and Baltic countries
Jenni Kononoff (PhD, MPharm) has been appointed as Medical Manager and Jonas Hinkkanen as Head of Regulatory Affairs for Biocodex Pharmaceutical and Medical Services (PhaMe). Jenni Kononoff is an experienced researcher and pharmacologist, who has a tot
Biocodex PhaMe employees will be out of office on 10th April 2020 due to Good Friday and on 13th April on the Second Easter Day. During the holidays, we would like to remind you to contact us by using our common mailboxes whenever applicable: Pharmacov
Check out our new position Regulatory Affairs Specialist and apply soon! Updated 24th of March 2020: The application for Regulatory Affairs Specialist is now closed and we thank all the applicants for their interest in the position. Candidates w
