Welcome to a seminar with Toxicology Knowledge Team Sweden (TKT). Speakers are Karin Svens, PhD, ERT, Consultant, and Carl-Johan Zettervall, PhD, ERT, Consultant.
The seminar aims to provide information on the scientific principles and the regulatory guidelines that govern the development of pharmaceuticals and medical devices (with regards to the non-clinical development), but with also a practical touch. Embarking on a “First in Human” developmental path, or the CE marking process for a medical device, is a major project step for any small biotech enterprise, and it is peppered with many business-critical decisions. Using our experience as toxicology consultants in many such projects, we will describe some of these potential risks and hurdles and point out how to de-risk where possible. In addition, for medical devices, there is a new regulatory landscape emerging in Europe, with the Medical Device Regulation (MDR) being implemented. The changes of the regulatory demands on the European market with regards to required documentation/data, and possible implications for a small company in the field, will be discussed.
Venue: Your computer.
Date and time: May 11th, 10:00-11:00.