RIS.WORLD

MEDICAMENTS

International

International – ICH guideline M13A on bioequivalence for immediate-release solid oral...

RIS.WORLD - 08/02/2023

ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...

USA – DSCSA: New interoperability ‘blueprint’ released

07/02/2023

Europe – Actions to support the development of medicines for children

07/02/2023

Europe – Public consultation on a multi-stakeholder platform to improve clinical...

07/02/2023

USA – FDA releases FY 2022 generic drug research summary

07/02/2023

DISPOSITIFS MEDICAUX

Europe

Europe – EMA to launch scientific advice pilot for high-risk devices...

RIS.WORLD - 08/02/2023

The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...

As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – 37 ème organisme notifié au titre du Règlement 2017/745

31/01/2023

USA – Lasers: FDA publishes guidance on surveying, leveling and alignment...

31/01/2023

USA – Authorization of Emergency Use of Certain Medical Devices During...

23/01/2023

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – Dealing with certification gaps (MDCG 2022-18)

23/01/2023

SANTE PUBLIQUE

Santé Publique

France – Le Snof, la Cnam et l’ordre des médecins obtiennent...

RIS.WORLD - 08/02/2023

PARIS (TICsanté) - L'assurance maladie, l'ordre des médecins et le Syndicat national des ophtalmologistes de France (Snof) ont obtenu le blocage d'un site internet...

France – La dotation pour 2023 du Health Data Hub fixée...

08/02/2023

International – World Health Organization releases new road map for breast...

07/02/2023

Breaking down “universal,” “inclusive,” and “accessible” medical device design

France – Syndrome de CLOVES : 1ère mondiale à l’hôpital Necker

30/01/2023

New guidance on biologics affects authorized generics

USA – FDA proposes easing blood donor requirements

28/01/2023

FORMATIONS

Formations

WEBINAR – DM Numériques et Intelligence Artificielle

RIS.WORLD - 14/03/2023

Intervenant : Professeur Jean-Gabriel GANASCIA Spécialiste d’intelligence artificielle (EurAI Fellow – European Association for Artificial Intelligence https://www.eurai.org/), d’apprentissage machine et de fouille de données, Jean-Gabriel GANASCIA est Professeur d’informatique...