Its contribution applies especially in relation to medical device regulatory pathways within pharmaceutical companies with drug device combination products.
One of the key growth areas in the industry is Drug/Device combination products. The new Medical Device Regulation, which came into effect in May 2017 and has a transition period of three years, requires pharmaceuticals and biopharmaceuticals companies with combination products to comply with the act.
Currently, the knowledge of the act and the associated standards to which the medical device industry have to comply is lacking in the pharma and biopharma industries. Also, bearing in mind the long development timelines for bio/pharmaceuticals, an increasing number of which are combination products, compliance at the time of regulatory submission requires compliance with the up-to-date version of the standards.
To enhance this knowledge Dr Behizad suggested the publication of a regular article with the purpose of updating both bio/pharma and medical device industries with the development stages of key applicable standards in the TOPRA monthly publication, The Regulatory Rapporteur. Since the beginning of 2017 three such articles have been published and have been generally well received by both the Medical Devices and the Bio/pharma industries. It is intended that the publication of these articles will continue.