The safety of the subject in any clinical trial is of paramount consideration. First in Human studies are special in this case as no data is available on how the investigational product will react in the human body. Preclinical data needs to be adequate to allow translation into a clinical study complying with all medical, scientific, ethical and regulatory aspects. Historical cases have shown that bridging preclinical and clinical is not always been adequate. The gap first needs to be understood and then strategies need to be developed to enable a smooth translation of the preclinical data of “research in animals” to the clinical research with First in Human studies.
20 Apr 2018
The health care sector finds itself in the midst of a fundamental transformation. All elements in this ecosystem are on the move: new insights in science and technology are only accelerating, leading to a vast number of innovations as never seen before; the image of how a ‘total health care solution’ will look like, is becoming more and more concrete; regulatory bodies are reconsidering their regulations, trying to keep pace with the speed of the evolutions; private and public health care insurers are looking for new models; patients and patient communities claim their role as active stakeholder; Life Sciences companies are seeking for a new position in the playing field, faced with an expanding number of new entrants, competitors and collaboration partners, …
25 Sep 2018
26 Sep 2018
On 25 & 26 September 2018 the Business Developers Program (BDP) Course will take place at the EY office in Amsterdam. This BDP Course specifically aims at junior to mid-level BD professionals who are driven to expand their knowledge on the BD process and to strengthen their BD competences.