Konexio Biotech launches a webinar on non-industrial manufacturing drugs by the Spanish Agency of Medicines and Medical Devices (AEMPS)

On November 8, the AEMPS published a new section on its website dedicated to non-industrially manufactured medicines (Advanced Therapies Medicines and Radiopharmaceuticals).

For this reason, Konexio biotech decided to opt for a webinar to address the steps and regulatory documentation necessary to comply with Regulation (EC) No. 1394/2007 and Royal Legislative Decree 1/2015, of July 24, which transposes the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code on medicinal products for human use.

During the webinar, our colleagues Abi Pérez and Marta Valverde, Heads of the Quality and Clinical Trials areas, respectively, resolved the main doubts about this update under the direction of our CEO, Andrea Romero Head of the Regulatory Area.

Thus, last Wednesday, January 24, Konexio managed to bring together more than a hundred professionals from the business, hospital and research network in 1 hour to discuss the application and interpretation of this new section and its impact on each field.