Skip to main content Skip to search Skip to main navigation

New EMA Executive Director: Emer Cooke from Ireland

On 25 June 2020, the Management Board of the European Medicines Agency (EMA) selected the Irish pharmacist Emer Cooke as the new EMA Executive Director from a list of candidates prepared by the European Commission.

She is called upon to make a statement before the Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament on 13 July 2020. The appointment is to take place immediately afterwards.   

Emer Cooke has been Director of the Regulation and Prequalification Department at WHO in Geneva since 2016. In the 30 years of experience she has gained in the regulatory field, she  already worked for the EMA. There she was Head of the Department of Inspections and the Department of International Affairs.   

We think that with their election EMA has a competent director at its head! 


Source:

EMA: Emer Cooke nominated as new EMA Executive Director 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

EDQM: Revised Guidance on Sister File Applications

EDQM: Revised Guidance on Sister File Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised its Guidance on applications for “sister files” (PA/PH/CEP (09) 141). The revision is intended to support consistent application of the procedure and provide greater clarity on the classification and assessment of the corresponding CEP applications.
Read more
Swissmedic Clarifies Requirements for QR Codes on Medicinal Product Packaging

Swissmedic Clarifies Requirements for QR Codes on Medicinal Product Packaging

Swissmedic has revised its guidance document “Mobile technologies” and added two new entries to the related questions and answers. The update follows an increasing number of queries regarding the details and placement of URLs, the positioning of QR codes and their captions.
Read more
EMA: Withdrawal of an Application due to Missing Confirmation of a Manufacturing Site’s GMP Status

EMA: Withdrawal of an Application due to Missing Confirmation of a Manufacturing Site’s GMP Status

EMA reported that Scholar Rock Netherlands withdrew its application for Isembyld after evaluation had progressed through the final round of questions. EMA’s provisional view was that the medicine could not be authorised because the applicant had not provided confirmation that the manufacturing site complied with EU GMP requirements.

Read more
France: ANSM Launches Pilot Project to Extend the Shelf Life of Medicines

France: ANSM Launches Pilot Project to Extend the Shelf Life of Medicines

The French medicines agency ANSM has published an update on its “Longue vie aux médicaments” pilot project aimed at extending the shelf life of medicines. Fourteen pharmaceutical companies responded to the call for applications. The project covers a total of 73 medicines, including commonly used products containing paracetamol, levothyroxine, melatonin or lithium.
Read more
How is First Air Verified and Monitored During Aseptic Process Qualification?

How is First Air Verified and Monitored During Aseptic Process Qualification?

Here's the answer:
Read more
Outsourced Activities in the GDP Environment Part I: Supplier Management

Outsourced Activities in the GDP Environment Part I: Supplier Management

Supplier management is the systematic management of a company´s relationship with its suppliers. It encompasses supplier qualification and customer audits as described in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

Read more
Previous
Next