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New SPIOMET4HEALTH

The Polycystic Ovary Syndrome the most common endocrine-metabolic disorder among women of reproductive age, affecting 5-10% of women worldwide. This syndrome is the most frequent cause of anovulatory subfertility, and it is also … See more

Actived: 3 days ago

URL: https://www.asphalion.com/news/spiomet4health-project-kick-off/

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 …

Category: Medical 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

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

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

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 EVENT 2nd BIOEQUIVALENCE WORKSHOP

WebThe workshop will provide a platform for an exchange of views between industry, regulators and academia. Join our expert, Lidia Cánovas, at the 2 nd …

Category: Health Go Health

Regulatory Operations: eCTD Publishing and eSubmissions Service …

WebAt Asphalion, we have been at the forefront of electronic submission of regulatory information since the introduction of eCTD. As a result of our flexible support and …

Category: Health Go Health

Global Regulatory Agencies Directory

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

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 standards …

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

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

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 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

The EU Regulatory Environment of Medical Device Software

WebA comprehensive list of the currently available standards and guidance documents recommended to be followed by MDSWdevelopers to achieve compliance with …

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 comprehensive …

Category: Food 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

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

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