European Medicines Agency
IDMP Compliance — Get Ready
March 26 by Pharmaceuticals & Biotechnology EditorIDMP regulations (Identification of Medicinal Products) are currently being finalised by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). These regulations will b...
Global Regulatory Leadership from European Medicines Agency
September 29 by Mollie Shields-UehlingI'm an American who has lived in Paris, London, and numerous other countries around the globe. It's atypical for my generation. The experience has helped me appreciate the best ideas and policies, whe...
European Medicines Agency Publishes Final Advice from Clinical Trial Advisory Groups
May 02 by Pharma IQ NewsThe European Medicines Agency (EMA) has published the final advice from the advisory groups that have been set up to inform the EMA in drafting its policy on proactive access to clinical-trial data....
European Medicines Agency Receives Interim Decisions of the General Court of the EU on Access to Clinical and Non-Clinical Information
May 02 by Pharma IQ NewsThe European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by...
Newly Published Draft Guideline on Similar Biological Medicinal Products
May 01 by Pharma IQThe European Medicines Agency (EMA) published draft guidelines today, 2nd May 2013 on Similar Biological Medicinal Products. The guideline outlines the general principles to be applied for s...
European Medicines Agency's Fergus Sweeney: Increasing Inspection Coverage in the Wake of Globalisation
November 07 by Pharmaceuticals & Biotechnology EditorWherever you sit in the world as a regulator, most of the clinical trials you receive in marketing applictaions, most of the manufacturing that takes place for products is taking place in terrioties...
European Medicines Agency's Hans-Georg Eichler: Top Priorities to 2015
November 07 by Pharmaceuticals & Biotechnology EditorDr. Hans-Georg Eichler, Senior Medical Officer for the European Medicines Agency, talks to Andrea Charles from Pharma IQ, abut the Agency's growth, starting a common language between p...
European Medicines Agency's Sabine Brosch on EudraVigilance and International Standards in Pharmacovigilance
November 01 by Pharmaceuticals & Biotechnology EditorSabine Brosch, Business Lead EudraVigilance and International Standardisation in Pharmacovigilance at European Medicines Agency (EMA), speaks to Andrea Charles from Pharma IQ, about collecting adver...
DIA Presents 10 Global Awards
June 19 by Andrea CharlesThe DIA Global Award winners were announced this morning at the opening plenary session of DIA 2011. Recognised for a range of achievements the winners were:Distinguished Career Award...
Get Ready for PIM Migration
November 23 by Pharma IQWhen implemented, the European Medicines Agency's (EMA) Product Information Management (PIM) system is intended to provide greater consistency and quality in information provided with marketing author...
European Medicines Agency: Breaking Down the Firewalls between the Regulator and Payer Communities
March 28 by Hans-Georg EichlerHans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA), joins Pharma IQ to discuss the potential impact of the pharmaco-vigilance legislation, and the top priorities of th...