Emmanuelle Voisin, Founder and CEO of Voisin Consulting Life Sciences, will present at the 15th Shanghai International Forum on Biotechnology & Pharmaceutical Industry BIO-FORUM and Bio-Med Exhibition May 29-31, 2013 in Shanghai, China.
Emmanuelle’s presentation, entitled “Forthcoming changes in medical devices & In-Vitro Diagnostics regulations in the European Union”, will comment on the evaluation and anticipated concentration of Notified Bodies, and the change of regulatory approval route for high-risk medical devices. In regards to IVDs, Emmanuelle will detail the anticipated creation of a 4-level classification of product-related risks, and the subsequent higher regulatory scrutiny that is expected for this type of healthcare products.
Emmanuelle will also chair a session on Latest Administrative Regulations: covering topics on Regulation and Policies of New Drug Approval, Medical Insurance and Market Access in China, EU and USA; and present a 20” overview on Current Developments in European Regulations.
Contact us if you wish to meet with Emmanuelle.