2018_05_22_FAR_aemps

The CMDh member of the Division of management of Procedures and area of Standardization of the department of Medicines for Human Use of the Spanish Agency of Medicines and Health Products (AEMPS), Ana López de la Rica Manjavacas, participated in the meetings of the Master's Degree MIDI, where she explained how this institution works to provide guarantees to society on medicines, health products, cosmetics and care products staff, while promoting the scientific-technical knowledge and put it at the service of society.

As the expert revealed to the students at Master's Degree, AEMPS -which is part of the EU Regulatory Network-"plays a decisive role at the EU regulatory level. Many of its technicians are part of the official list of European experts, who also contribute to a high and active Spanish representation in the different committees of the European Medicines Agency (EMA) and in numerous groups of work". "Likewise," he continued, "it collaborates with the World Health Organization (WHO) by translating the guidelines for ATC classification and the assignment of DDD, in the translation of the International Nonproprietary Names (INNs) and participates in the biannual INN Consultations meetings".

New support office for the research

According to the directive, " arbitration, drug registration procedures, public reports on assessment, therapeutic positioning, etc., are also part of this exciting regulatory world". "AEMPS has also set up the Office for Innovation Support and knowledge on medicinal products, with the aim of integrating, coordinating and promoting the various activities and initiatives to support research innovation and to obtain additional knowledge on medicinal products on framework of the network European Medicines Agencies," he added.

Finally, Ana López de la Rica stressed that access to medicines in a reasonable time "can also be regulated through an adequate availability of medicines in exceptional circumstances; such as compassionate use, off-label use and foreign medicines, as well as through progressive adaptations of the Marketing Authorization of medicines".

The meetings at Master's Degree MIDI offer student the opportunity to learn about the latest trends and the most interesting topics in the sector, explained by the professionals who are implementing them. It is also an excellent opportunity to expand your contacts with the industry.