With the nomation of Christine Hirt, EXTEDO is now part of the ISO IDMP standardization process of medicinal products for human use. We are exited to be able to take part in shaping tomorrow’s regulatory standards landscape.
Ottobrunn, Munich/Germany (PRWEB UK) 28 August 2014
EXTEDO, a key Regulatory Information Management solutions provider for life sciences firms, today announced that Christine Hirt, Managing Consultant at EXTEDO, has been nominated as the German delegate to the Medical Standards Committee (NAMed) at the DIN (Deutsches Institut für Normung e.V./German Institute for Standardisation).
EXTEDO’s key operational focus is on optimizing clients’ eRegulatory business processes. Next to providing cutting edge technology to industry and authority customers, EXTEDO is commited to advancing industry standards. More than a few employees are involved in organizations, committees, and working groups where they dedicate time and knowledge to developing and advancing the regulatory standards world.
The Medical Standards Committee at DIN is responsible for the national standardization work and represents the German standardization interests at both the European and the international level in the areas medical devices; transfusion, infusion and injection; laboratory medicine and clinical chemistry; sterilization, disinfection, sterile supply; medical microbiology and immunology, technical aids for disabled persons, and health informatics. This mandate covers the development of standards in the mentioned areas with the objective of establishing a high quality level for the standardized products and procedures and thus making an important contribution to patient safety.
Christine Hirt has been appointed delegate to the Working Group WG6 (Pharmacy) for the ISO IDMP standard. ISO IDMP (International Organization for Standardization Identification of Medicinal Products) is an international standard for the electronic transmission of medicinal product information. It has been developed by initiative of ICH (International Conference on Harmonization) in a joint collaboration with ISO and HL7 (Health Level Seven International), in course of implementing the pharmacovigilance regulations. It enables the unique identification of medicinal products at international level, wherever required e.g. in Pharmacovigilance or Risk Management.
“With the nomation of Christine Hirt, EXTEDO is now part of the ISO IDMP standardization process of medicinal products for human use”, said Martin Schmid, CEO for EXTEDO. “It is our mission to redefine regulatory information management. With this nomination we have taken a further step towards accomplishing our goals. We are exited to be able to take part in shaping tomorrow’s regulatory standards landscape.”
Next to DIN, EXTEDO also participates in BPI (Bundesverband der Pharmazeutischen Industrie e.V./German Pharmaceutical Industry Association), DIA (Drug Information Association), HL7 and IRISS (Implementation of Regulatory Information Submission Standards).
EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). EXTEDO’s focus is on optimizing clients’ eRegulatory business processes. The company’s enabling technology, the EXTEDOsuite, is unique in that it covers the complete regulatory landscape including: product registration planning & tracking (IDMP), submission publishing & lifecycle management, pharmacovigilance management and document management. Today, EXTEDO serves over 700 customers in 60 countries, including the EMA and more than 25 regulatory authorities worldwide.
For more information visit http://www.extedo.com.