CATALONIA.HEALTH, organizes the 10th edition of the Hard Reg Cafe. This event will provide a general overview of the ISO IDMP (Identification of Medicinal Products) regulatory framework, a global standard designed to harmonise and standardise drug information in a unique and unambiguous way, thus improving safety, transparency and decision-making for all parties involved.   

In the European Union, the implementation of these standards is led by the European Medicines Agency (EMA). This session will introduce the strategy and the current state of its implementation in the EU, as well as some key use cases that illustrate its practical application in various areas such as pharmacovigilance, helping in regulatory decision-making, having data available for the management of supply problems or cross-border electronic prescription. 

This event will be an excellent opportunity to understand its scope and impact, as well as the challenges that remain to be addressed and that will allow an application of the standard at European and global level. 

Speaker: 

• Blanca Pérez, senior technician in the Division of Procedures for the Registration of Medicines for Human Use, Spanish Agency of Medicines and Health Products (AEMPS). As a member of the AEMPS, she has participated in the development of the European guide for the implementation of ISO IDMP standards in the European Union and in the adaptation and development of the AEMPS database and systems for the implementation of ISO IDMP standards and SPOR domains in full. 

For: researchers and product development managers, regulatory managers, consultants and advisors from biotech, medtech, pharma and digital health companies. 

Language: Spanish 

Registration: 

• CATALONIA.HEALTH members: free 

• Non-members: €40 (VAT not included) 

Questions: Laura Iglesias (Business Development Manager) laura.iglesias@cataloniabioht.org 

Date and time: Wednesday, November 27th, 2024, 11:00 - 13:00 h 

Site: online 

With the support of