adelage

Discipline

Droit (17) Sciences de l'information et de la communication (5) Economies et finances (4) Sociologie (2) Education (2) Histoire, Philosophie et Sociologie des sciences (1)

Type de document

Autres (31) Billets de blog (31)

Date

Source

ELSIBI (31)

Mot-clé

information (13) Will (9) Will (9) Manufactures (8) sécurité (6) santé (6) Regulations (6) Regulations (6) Medical instruments and apparatus (6) Health (6) January (6) Health (6) Process (Law) (5) Drugs (5) puits (4) technologie (4) industrie (4) Treatment (4) Technology (4) Patients (4) Medical care (4) Industries (4) Evaluation (4) Technology (4) Practice (4) Patients (4) Quality (4) industrie pharmaceutique (3) inspection (3) document (3)

Documents écrit par adelage (31) | parle de adelage (1357)

International Conference on Harmonisation (ICH) - ICH M11 updated Technical Specification document and Step 2 presentation now available

adelage (2025)

Federal Commission for the Protection Against Health Risks (COFEPRIS) - COFEPRIS issues updated Good Manufacturing Practice (GMP) guidelines

adelage (2025)

Pharmaceuticals and Medical Devices Agency (PMDA) - PMDA notice

adelage (2025)

Medicines and Healthcare products Regulatory Agency (MHRA) - Implementation of medical devices future regime

adelage (2025)

MHRA Scientific Advice: advance notice of changes

adelage (2025)

A National Institute for Health and Care Excellence (NICE) - New guidance on the use of surrogate endpoints in cost-effectiveness analysis for use in Health Technology Assessment (HTA)

adelage (2025)

European Medicines Agency (EMA) - Q&A clinic on web-based electronic Application Form (eAF) functionalities for centrally authorised products (CAPs) and non-CAPs variations

adelage (2025)

Pharmacovigilance risk assessment committee (PRAC): Work plan 2025

adelage (2025)

Food and Drug Administration (FDA) - Recommendations to reduce the risk of transmission of mycobacterium tuberculosis (Mtb) by human cells, tissues, and cellular and tissue-based products (HCT/Ps)

adelage (2025)

FDA - Considerations for the use of artificial intelligence to support regulatory decision-making for drug and biological products

adelage (2025)

FDA - Considerations for complying with 21 CFR 211.110

adelage (2025)

FDA - Communications from firms to health care providers (HCPs) regarding scientific information on unapproved uses of approved/cleared medical products: questions and answers guidance for industry

adelage (2025)

FDA - Study of sex differences in the clinical evaluation of medical products

adelage (2025)

Combined FDA and sponsor oncologic drugs advisory committee briefing document

adelage (2025)

FDA - Considerations for including tissue biopsies in clinical trials

adelage (2025)

International Council for Harmonisation (ICH) - The ICH E6(R3) Guideline reaches Step 4 of the ICH Process

adelage (2025)

Catapult's Network established to identify opportunities for regulation to support innovation within advanced therapies

adelage (2025)

Medicines and Healthcare products Regulatory Agency (MHRA) - MHRA implements new regulatory framework on decentralised manufacture

adelage (2025)

MHRA releases safety communications guidance for medicines, medical devices and other healthcare products

adelage (2025)

A National Institute for Health and Care Excellence (NICE) - NICE recommends lisocabtagene maraleucel for treating people with large B-cell lymphoma

adelage (2025)

Human Tissue Authority (HTA) - HTA publishes operational data

adelage (2025)

European Commission (EC) - International Coalition of Medicines Regulatory Authorities (ICMRA) publishes collaborative hybrid inspection pilot (CHIP) summary report

adelage (2025)

European Directorate for the Quality of Medicines (EDQM) EDQM On Air – The evolution of biologicals in the European Pharmacopoeia

adelage (2025)

European Medicines Agency (EMA) - ACT EU launches new clinical trial map in the EU

adelage (2025)

EMA recommends first topical gene therapy for dystrophic epidermolysis bullosa

adelage (2025)

EMA – Publication of an Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

(26 mars 2025)

EMA – Draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Revision 1

(26 mars 2025)

EMA – Twelfth Industry Standing Group (ISG) meeting

(26 mars 2025)

UK – MHRA drafts mRNA cancer immunotherapy guidance

(26 mars 2025)

Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products

(26 mars 2025)

UK – Decision tree for navigating nanotechnology-based products for medical application

(26 mars 2025)

UK – Access, new active substance and biosimilar work sharing initiatives

(26 mars 2025)

UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

(26 mars 2025)

UK – NICE approves Vertex’s Casgevy one-time gene therapy for sickle cell disease

(26 mars 2025)

Europe – European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines

(25 mars 2025)

EMA – Publication of the Consolidated 3-year work plan for the Emergency Task Force (ETF)

(25 mars 2025)

EMA – Publication of the presentation materials and the video recording of the European medicines agencies network strategy (EMANS) to 2028 webinar held the 13 February 2025

(25 mars 2025)

HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling the safe and responsible use of AI held the 5 November 2024: Publication of the report and the video recording of the event

(25 mars 2025)

EMA - New EU rules for health technology assessments become effective

(25 mars 2025)

USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing

(25 mars 2025)