Which regulatory pathway should a Sponsor follow to conduct a clinical investigation in the pilot stage (i.e. first in human, early feasibility) in accordance with the Regulation (EU) 2017/745 (MDR)? The MDR describes different types of clinical investigations that follow different regulatory pathways. The choice of the appropriate regulatory pathway...
What are the general differences and improvements related to clinical investigations under the new Regulation (EU) 2017/745 (MDR) as compared to the Directives 93/42/EEC and 90/385/EEC? Regulation (EU) 2017/745 (MDR) will progressively replace both Directives (93/42/EEC and 90/385/EEC) and their transpositions in national law. The first difference is regarding the...
20th of May is celebrated as International Clinical Trials Day. The date of May 20 was chosen to commemorate the day James Lind began his study to determine the causes of scurvy – a study considered the first randomized clinical trial. It all began in May 1747, when British...
We would like to thank you for very interesting time and welcome you during two exciting days of meetings at Outsourcing in Clinical Trials conference in Barcelona. After a break of 3 years, it was a great pleasure to meet live, freely, without technology. Our Booth #10 has been visited...