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FDA's new automated system to assist in making import decisions for FDA-regulated products seems to shorten up processing time, according the agency. Learn more about the FDA Automated Commercial Environment/International Trade Data System.
The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.
Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.
The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.