Verordening (EU) Nr. 536/2014: aanvraagdossier initiële aanvraag en substantiële wijziging

In de bijlagen I en II van Verordening (EU) Nr. 536/2014 is terug te vinden welke vereiste documentatie en informatie moet worden opgenomen in het aanvraagdossier voor een initiële aanvraag en voor van een substantiële wijziging.

Rennes 15 januari 2016, Frankrijk (BIA 10-2474)

Richtlijnen en een selectie van in het nieuws en de media verschenen berichtgeving:


Continue reading Rennes 15 januari 2016, Frankrijk (BIA 10-2474)

Operante conditionering

“Operant conditioning (also, “instrumental conditioning”) is a learning process in which behavior is sensitive to, or controlled by, its consequences. For example, a child may learn to open a box to get the candy inside, or learn to avoid touching a hot stove. In contrast, classical conditioning causes a stimulus to signal a positive or negative consequence; the resulting behavior does not produce the consequence. For example, the sight of a colorful wrapper comes to signal “candy”, causing a child to salivate, or the sound of a door slam comes to signal an angry parent, causing a child to tremble.”


BF Skinner Foundation – Pigeon Turn

Clicker Training a Cat to Ring a Service Bell

Pecan the cat, rings bell for treats

Transforming Healthcare for Children and Their Families | Doug Dietz | TEDxSanJoseCA 2012

“As a principal designer for GE Healthcare, Doug had been designing diagnostic imaging equipment for more than 20 years when he realized that young patients’ actual experience of this cutting — edge technology was, well, awful. Children were often so terrified by the prospect of lying alone inside the huge, noisy machine that they often had to be sedated just to get through the experience. Doug put together a team of experts to solve this problem, including staff from a local children’s museum, kids and hospital staff. The result was an innovative, design-driven solution that utterly transformed the experience for children. … “

– TEDxSanJoseCA 2012 (May 21, 2012)