EMA Management Board – highlights of March 2020 meeting

Europe- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021

First monthly summary safety report for COVID-19 vaccine Comirnaty Starting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports submitted monthly by marketing authorisations holders...

Europe – Cyberattack on EMA – Update

The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines have been...

UK – NICE backs GSK’s Zejula in advanced ovarian cancer

In the UK, around 7,500 women are diagnosed with ovarian cancer each year – 60% of which will be diagnosed at a late stage,...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medicines and Medical Devices Bill: overarching documents

The impact assessment evaluates the measures in the Medicines and Medical Devices Bill and gives an overarching assessment of the impact they will have. The illustrative statutory...

USA – COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting...

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic....
EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list

Europe – EMA offers parallel Article 58, centralized authorization reviews

The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Certification ISO 9001:2015 de l’EDQM maintenue

Le certificat ISO 9001:2015 de la Direction européenne de la qualité du médicament et soins de santé (EDQM) a été maintenu suite au second...

Europe – Treatments and vaccines for COVID-19: post-authorisation

The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety...

Europe – Treatments and vaccines for COVID-19: authorised medicines

EMA's Committee for Medicinal Products for Human Use (CHMP) has evaluated these medicines and issued a scientific opinion on their use in patients with COVID-19...

Europe – Treatments and vaccines for COVID-19: medicines under evaluation

EMA is assessing all applications for COVID-19 medicines under the minimum timeframe necessary to allow a thorough evaluation of the medicine’s benefits and risks, in accordance with its usual standards for quality, safety and effectiveness...

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