News

Updates to eAFs

06.02.2018 New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released. The main changes include the impl... Read More

Billev Pharma East experience from conference in London

05.02.2018 We recently attended a pharmacovigilance and regulatory conference which is organised annually by European stakeholder association Medicines for Europe whose member is also Billev Pharma East d.o.o.. ... Read More

FDA’s May 2018 eCTD deadline

30.01.2018 The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Rese... Read More

PhV and RA conference in London from 24th-26th of January

09.01.2018 Billev Pharma East will attend the 11th Pharmacovigilance Conference and the 17th Regulatory and Scientific Affairs Conference on 24th-26th of January in London. You can visit us on our booth and disc... Read More

SPOR going live 15 December 2017

14.12.2017 Billev Pharma East is ready for the first phase of SPOR implementation with first services to go live: OMS (Organisations management service) and RMS (Referentials management service). The portal is b... Read More

Let’s meet at the 11th Pharmacovigilance Conference

23.11.2017 Billev Pharma East will attend the 11th Pharmacovigilance Conference and lead a workshop on Management of Reference Safety Information which is a challenge for the pharmaceutical industry from detecti... Read More

NeeS is out from MRP (eCTD only for all submissions in EU procedures) from 1 January 2018

13.11.2017 We in Billev Pharma East are ready for many years. Pharmaceutical companies will no longer be able to submit MRP (mutual recognition procedure ) applications in the NeeS submission format, as outlined... Read More

Pharmacovigilance Conference

08.11.2017 Billev Pharma East will attend the 11th Pharmacovigilance Conference and lead a workshop on Management of Reference Safety Information which is a challenge for the pharmaceutical industry from detecti... Read More

BREXIT

16.09.2017 Billev Pharma East is prepared and up to date to support you with the regulatory and pharmacovigilance implications related to ‘hard’ BREXIT, being part of the task force. European Commission and ... Read More

CPhI Worldwide, Frankfurt

16.09.2017 Billev Pharma East will attend CPhI worldwide on 24 – 26 October 2017, Messe Frankfurt, Germany: https://www.cphi.com/europe/. Important event for pharmaceutical sector, where you can establish ... Read More