CAPRA Dinner Meetings, Webinars and Symposia Schedule

Date/Location Speakers/Topics

Tuesday, March 20

Sheraton Montreal Airport Hotel
555 Boulevard McMillan
Dorval, Quebec

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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.


May 15 – 16

Regulatory Review of Drugs & Devices – R2D2 Workshop

MARK YOUR CALENDARS for May 15 & 16, 2018! 

CAPRA will host a two day consultation workshop to provide an update from Health Canada on the substantial regulatory reform initiatives underway. The proposed topics include: health care system needs concept, health technology assessment collaboration, use of foreign reviews/decisions, stop the clock and release of clinical information regulations/guidance. Further, there will be the option to attend concurrent sessions on medical device projects related to building better access to digital health technologies and the provision of early scientific advice for medical devices.

The event format will include presentations followed by breakout sessions to address specific questions posed by Health Canada and plenary sessions to present the feedback received.

This event will be of interest to Regulatory Affairs and Market Access professionals. Please share the news of this event within your organization.

 Save these dates, May 15 & 16, 2018 and plan to attend this important event.  Registration details and agenda will follow soon!