+1 (514) 840-1234 info@cra-school.com

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

Non-members: $75

Please register online at:  http://www.craconline.ca/meeting.php

Members: please log in to Members Only Area and then register for the meeting.
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.
1)  To register, go to http://www.craconline.ca/meeting.php, scroll to the bottom of the page and  check for the meetings list, right now there is only 1 meeting for Montreal – Press on Register
2) Scroll again to the bottom of the page – fill in the fields – where it says Company Name – enter “CRA-School and Student ID Number”   If you don’t know your Student ID Number, you can just put in the School name.

Free shuttle bus available from the airport to the hotel. Contact CRA School for carpooling transport arrangements.