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MEETINGS AND SYMPOSIA REGISTRATION

Payment:

The three options for payment are as follows:

  1. Credit card payment online
  2. Payment via cheque
  3. Third-party payment via cheque or credit card

If paying by cheque, you will need to print the confirmation and mail it to us with payment. Further instructions and the mailing address will be provided in the confirmation email.

Please note: Under the new incorporated CAPRA, credits for meetings can no longer be issued. In order to attend a dinner meeting, payment must be received prior to the meeting (either by mail in advance of the meeting or in person at the registration desk). Please be advised that cheques should not be mailed less than a week prior to the meeting. Registrants for whom payment has not been received will be refused entry to the meeting.

Process:

Add the "Buy Tickets" option to your cart. After completing the checkout process, you will be provided with a link to the Event Registration form(s) where you can provide us with the details of the attendee(s). If you have registered for previous events, then you can simply confirm your previously submitted details, or make changes where needed.


Montreal Dinner meeting

Date: Tuesday, March 20, 2018
 
Place: Sheraton Montreal Airport Hotel, 
555 Boulevard McMillan, Dorval, Quebec
 
Time: Registration and reception: 5:30-6:00 pm 
Presentation: 6:00-7:15 pm 
Dinner: 7:15-8:30 pm

Dinner Meeting Title: Updates on Health Canada’s discretionary authority to disclose CBI under paragraph 21.1(3)(c) of the Food and Drugs Act and regulatory proposal to permit public release of clinical information.

Description: Health Canada currently treats information provided by manufacturers in drug submissions and medical device applications as confidential business information (CBI). This includes the clinical data that is used to assess the safety and efficacy of a drug in humans, and the safety and effectiveness of medical devices.  International norms on clinical data transparency have evolved significantly over the past decade and include initiatives lead by manufacturers as well as those lead by other regulators (mainly EMA and US FDA). 

 This presentation will focus on Health Canada’s two recent data sharing initiatives:

1.            New authority under the Food and Drugs Act that gives the Minister of Health discretionary authority to disclose CBI to eligible persons for the purpose of protecting or promoting human health or the safety of the public (paragraph 21.1(3)(c)).

2.            Health Canada’s regulatory proposal to permit public release of clinical information in drug submissions and medical device applications.

Speaker: Marcin Boruk, Senior Policy Analyst, RMOD, Health Products and Food Branch

Marcin Boruk is a senior policy analyst in the Resource Management and Operations Directorate, Health Canada working on the projects related to clinical data transparency.
Prior to working in the Resource Management and Operations Directorate, Marcin was senior policy analyst in the Office of Legislative and Regulator Modernization where he worked on projects to modernize the Canadian Food and Drugs Act and corresponding regulatory frameworks.

 

Date:Tuesday, March 20, 2018
Place:Sheraton Montreal Airport Hotel
555 Boulevard McMillan
Dorval, Quebec
Time:Registration and reception: 5:30-6:00 pm
Presentation: 6:00-7:15 pm
Dinner: 7:15-8:30 pm
Registration Deadline: Thursday, March 15, 2018 4pm
Reservations or cancellations cannot be accepted after the deadline.