In life sciences, our future is heavily governed by the actions of the major regulatory agencies in the world. To get a better view into the future of 2015, we carefully listened to the information heard at conferences, published in official channels on the web and gleaned from our colleagues within the life sciences community. I’d like to share with you the important topics that may have a critical impact on your business. These topics should be on your radar for 2015.
Let’s start with what I mean by “radar.” Radar was a term that was invented in the beginning of World War II (1940) by the US Navy and it stands for the detection of objects using radio waves. Early on, the military was interested in ships and planes. More so, they were interested in whose ships and planes were in motion and where are they going. They wanted to know if these objects were a threat.
A more current use of the metaphor can be found in the tremendous complexity of airport traffic control and the vast number of objects in motion. In Life Sciences, we not only need to listen to government agencies and standards organizations that govern this regulated business but we also pay attention to what experiences sponsors are having and what the vendors are seeing as well. Timelines for implementation are considered for priority. Conditions of non-compliance are the threat. As in times of war, not all threats can be considered equal.
One of the regulatory initiatives that has emerged from Europe over the past several years is IDMP, and its predecessor XEVMPD. IDMP stands for Identification of Medicinal Products, and is a set of standards whereby safety events can be consistently linked to a particular product anywhere in the world. On the surface, the association of an Adverse Event to a product is elementary. But it’s not so simple. The company identifies its products differently in different markets of the world. Implied within these standards is a requirement to correlate all Continue reading