ICH S5 (R3) guideline on reproductive toxicology

Europe – ICH S5 (R3) guideline on reproductive toxicology

The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
ICH E9 statistical principles for clinical trials

Europe – ICH E9 statistical principles for clinical trials

This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development....
Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation

Europe – Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP)...

Sponsors (holders of the OMP designations) are advised to provide to the European Medicines Agency the following supporting information with their application for the...
European Commission DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs

Europe – European Commission DG Health and Food Safety and European Medicines Agency Action...

The term “advanced therapy medicinal products” (“ATMPs”) is used to designate gene therapies, somatic cell therapies and tissue engineered products. In the EU, these products...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee : 10-13 February 2020

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee : 10-13 February 2020

PRAC recommends restrictions in use of cyproterone due to meningioma risk Following a review of the risk of meningioma (a rare tumour of the membranes covering...
”Blue – Box” requirements

Europe – ”Blue – Box” requirements

Additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC as amended is outlined...
UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

UK – UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials...
Ph. Eur. Supplement 10.2: CEP holders are invited to update their applications

Europe – Ph. Eur. Supplement 10.2: CEP holders are invited to update their applications

Supplement 10.2 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be...
NICE refuses Keytruda, Inlyta cancer combo

UK – NICE refuses Keytruda, Inlyta cancer combo

NICE already routinely commissions various drugs for first-line treatment of RCC, including Aveo’s Fotivda (tivozanib), Pfizer’s Sutent (sunitinib) and an Opdivo (nivolumab) Yervoy (ipilimumab)...
CAT monthly report of application procedures, guidelines and related documents on advanced therapies

Europe – CAT monthly report of application procedures, guidelines and related documents on advanced...

The Committee for Advanced Therapies (CAT) held its 122nd meeting on 22 – 24 January 2020. The CAT Monthly Report includes statistical data on CAT...

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