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Changes in Medical Device Regulations: Navigating the New …

WEBIntroduction. The ever-evolving world of medical devices is not just limited to technological advancements; medical device regulations are constantly adapting to …

Actived: 3 days ago

URL: https://www.asphalion.com/changes-in-medical-device-regulations-navigating-the-new-landscape/

Global Regulatory Agencies Directory

WEBGlobal Regulatory Agencies Directory. In a globally connected healthcare environment, understanding the various pharmaceutical regulatory agencies is of …

Category:  Health Go Health

New MDR & IVDR Language requirements for manufacturers

WEBThe European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has recently released a key document that provides a …

Category:  Food Go Health

New SPIOMET4HEALTH Ongoing clinical trials on Polycystic …

WEBAn international clinical trial is underway to evaluate on a large scale the effects of the first specific treatment for Polycystic Ovary Syndrome, a condition that …

Category:  Health Go Health

What you need to know about Health Canada

WEBCookie Duration Description; _ga: 1 year 1 month 4 days: Google Analytics sets this cookie to calculate visitor, session and campaign data and track site usage for …

Category:  Health Go Health

Joining BHH to boost technological & digital innovation in …

WEBAsphalion has signed an agreement to be part of Barcelona Health Hub (BHH), the international digital health institution aiming to promote innovation in digital …

Category:  Health Go Health

PRESS RELEASE SPIOMET4HEALTH

WEBSPIOMET4HEALTH is a new Horizon 2020 health project whose main objective is to study, in a multi-centric phase II clinical trial, a new treatment for PCOS in adolescent girls and …

Category:  Health Go Health

New ACCESS CONSORTIUM New Promise Pilot Pathway

WEBThe Access Consortium is a collaborative initiative between five Health Authorities: Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), …

Category:  Health Go Health

New SPIOMET4HEALTH

WEBSPIOMET4HEALTH is an EU-funded health project whose main objective is to study, in a multi-centric phase II clinical trial, a new treatment for Polycystic Ovary …

Category:  Health Go Health

New Barcelona Health Innovation Week 2024 Regulatory tips for …

WEBFor the second year in a row, Barcelona will celebrate a week devoted to innovation, acceleration, technology and transformation in healthcare, showcasing the …

Category:  Health Go Health

Digital transformation and pharmacovigilance: technology update

WEBSeptember 17, 2019. | Archive. Today, our experts Núria Romero, Sonia López, Nuria Cabello and Bernat Autonell participated in the workshop “Digital transformation and …

Category:  Health Go Health

News & Events

WEBThrough a fun-filled scavenger hunt to collect the necessary parts and then getting them assembled by the different teams! At Asphalion, we are a committed …

Category:  Health Go Health

New Health Canada: New Deadline for DMF in eCTD Format

WEBIn May 2018, Health Canada proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) …

Category:  Health Go Health

New PROJECT ORBIS PARTNER Faster access to treatment

WEBProject Orbis Partner facilitates the current submission and review of oncology products which can help cancer patients access those drugs faster and easier. This …

Category:  Cancer Go Health

New DMFs in Health-Canada

WEBFrom 1 st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the …

Category:  Health Go Health

New Implementation of the Canadian Labeling in XML format

WEBHealth Canada is committed to enhance the access to approved regulatory health information by developing a consistent solution using XML format, data …

Category:  Health Go Health

New Health Canada: Regulatory Enrolment Process (REP)

WEBJune 15, 2021. | Regulatory Operations: eCTD and Submissions. As of October 1st, 2020, the use of the Regulatory Enrolment Process (REP) is mandatory for pharmaceutical, …

Category:  Health Go Health

New Health Canada: reg activity types scope for eCTD

WEBSupplement to an Abbreviated New Drug Submission (SANDS). From 1st June 2019, Health Canada will also request the Remainder of Division 8 activities and …

Category:  Health Go Health

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