Biosimilar development: FDA, HC and EMA
Speaker: Patricia Smith, PhD, Regulatory Affairs Manager, US Strategic Regulatory Services, Optum Insight
Montreal: 5 Dec 2013 6:00 Novotel Montréal Aéroport, 2599 Boul. Alfred-Nobel, St. Laurent H4S 2G1.
Learning objectives: 1.Understand the different requirements for the regulatory agencies 2.“Flip” European biosimilar submissions for Canada and the US 3.Interact with the regulatory agencies with regard to biosimilars
Ograniser: Clinical Research Association of Canada
Cost of dinner meetings (buffet included):
CRAC Members / Students (w/ ID): $50
Please register online at: http://www.craconline.ca/meeting.php
Students: When registering, in Company field type Student + School Name + ID number, choose Pay at the door (do not chose PayPal) and bring your payment and Student ID to be shown at the desk.
Free shuttle bus available from the airport to the hotel. Contact CRA School for carpooling transport arrangements.