Public release of clinical information - stakeholder meetings and engagement activities

The table below lists meetings between Health Canada officials and stakeholders concerning the proposal for public release of clinical information. The documents listed in the table are available to members of the public upon request, for the sole purpose of ensuring greater transparency. The disclosures made as part of this new policy are not part of the consultation process. Health Canada is therefore not seeking any feedback on any of these documents. To request a copy send your request by email, citing the meeting number, to: hc.rmod.stakeholders-intervenants.dgro.sc@canada.ca. Oral or written communication for the purposes of making simple enquiries or requests for information and that do not have any relevance, in Health Canada's view, to the development of policies related to the public release of clinical information will not be published. Learn more about how Health Canada makes information, data, publications and reports available to Canadians.

Stakeholder meetings and engagement activities
Meeting number for document requests Date Topic Organization(s) Type of Interaction Purpose Health Canada Office(s) Document(s) shared
1 2017-04-10 Bilateral meeting with Canadian Pharmacists Association (CPhA) & Canadian Society of Hospital Pharmacists (CSHP) on PRCI proposal Health Canada, CPhA & CSHP Stakeholder-initiated meeting To solicit early feedback and respond to stakeholder input regarding the published proposal for PRCI. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Agenda Item Summary (English)
2 2017-04-26 Technical Briefing on PRCI for stakeholders Various drug and medical device manufacturers, health professionals, academic researchers, and patient organisations Health Canada-initiated meeting/event To clarify Health Canada's regulatory proposal for public release of clinical information, and to address early stakeholder feedback. Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division
  1. Presentation (English)
  2. Presentation (Francais)
3 2017-04-28 Follow-up - PRCI for stakeholders Health Canada, Drug Safety Canada Stakeholder-initiated teleconference To clarify Health Canada's regulatory proposal for public release of clinical information, and to respond to specific stakeholder feedback. Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division n/a
4 2017-06-01 Follow-up - PRCI for medical devices industry stakeholders Health Canada, MEDEC representatives Stakeholder-initiated meeting To address elements of MEDEC's response to the public consultation on the White Paper. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Meeting Summary (English)
  2. Speaking points (English)
5 2017-06-20 Follow-up - PRCI for industry stakeholders Health Canada, representatives for Johnson & Johnson and subsidiary (Janssen) Stakeholder-initiated meeting To elaborate on stakeholder comments submitted during the White Paper's public consultation period Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division
  1. Stakeholder Presentation - EMA Data Disclosure Roadmap (English)
  2. Stakeholder Presentation - Janssen Comments: Public Release of clinical information in drug submissions and medical device applications (English)
  3. Stakeholder Presentation - Johnson & Johnson Medical Device Comments: Public release of clinical information in drug submissions and medical device applications (English)
6 2017-09-05 Follow-up - PRCI for stakeholders Health Canada, Health Law Institute - Dalhousie University Stakeholder-initiated teleconference To clarify Health Canada's regulatory proposal for public release of clinical information, and to respond to specific stakeholder feedback. Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division n/a
7 2017-09-08 Follow-up - PRCI for stakeholders Health Canada, University of Toronto St. Michael's Hospital Stakeholder-initiated teleconference To clarify Health Canada's regulatory proposal for public release of clinical information, and to respond to specific stakeholder feedback. Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division n/a
8 2017-09-13 to
2017-09-15
Clinical Trial Disclosure and Data Transparency Conference, Drug Information Association (DIA), Rockville, MD, USA Drug Information Association (DIA), and various member organisations including Health Canada Stakeholder community event For an individual panelist (representative of Health Canada) to update other members/stakeholders on current status of PRCI at HC. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Presentation (English)
9 2017-09-27 An Office of the Privacy Commissioner of Canada (OPCC) research project on data transparency for clinical trial patient data Health Canada and OPCC contractors (researchers) Stakeholder-initiated teleconference To inform HC of the OPCC's ongoing research project on clinical trial data transparency in Canada & establish contacts for reference or further consultation. Resource Management and Operations Directorate, Information Sciences and Openness Division n/a
10 2018-02-21 Follow-up - PRCI for industry stakeholders Health Canada, representatives for Johnson & Johnson and subsidiary (Janssen) Stakeholder-initiated meeting To elaborate on stakeholder comments submitted during the draft regulations’ public consultation period Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division
  1. Presentation: “J&J Experience with EMA Policy 0070” (February 2018)
11 2018-03-23 Follow-up - PRCI for industry stakeholders Health Canada, representatives for IMC (Innovative Medicines Canada) Stakeholder-initiated correspondence To elaborate on stakeholder comments submitted during the draft regulations’ public consultation period Assistant Deputy Minister’s Office (HPFB), Resource Management and Operations Directorate, Director General's Office, & Information Sciences and Openness Division
  1. IMC letter to HPFB-ADM (March 19, 2018)
  2. HPFB-ADM response to IMC (March 23, 2018)
12 2018-04-13 Technical Briefing on the draft Guidance document for PRCI for stakeholders Various drug and medical device manufacturers, health professionals, academic researchers, and patient organisations Health Canada-initiated meeting/event To clarify Health Canada's draft Guidance document for public release of clinical information, and to address early stakeholder feedback. Resource Management and Operations Directorate & Information Sciences and Openness Division
  1. Presentation (English)
  2. Webex Participant List
13 2018-04-26 Follow-up - PRCI for industry stakeholders Health Canada, MEDEC representatives Stakeholder-initiated correspondence Update on Public Release of Clinical Information Director General's Office, Resources Management and Operations Directorate
  1. Meeting Summary (English)
14 2018-05-10 Follow-up - PRCI for industry stakeholders Health Canada, representatives for IMC (Innovative Medicines Canada) Stakeholder-initiated meeting Update on Public Disclosure of Clinical Information HPFB Bilateral Meeting Program
  1. Agenda Item Summary for IMC’s update
  2. IMC submission on amendments to Food and Drug Regulations
  3. IMC submission on amendments to Patented Medicine Regulations
  4. IMC submission on the White Paper (PRCI)
Stakeholder Reference Group (SRG) meetings:
SRG1 2017-10-13 SRG1 - Implementation of PRCI - Launch of Stakeholder Reference Group Health Canada, HPFB's Stakeholder Reference Group for Implementation of PRCI (representative body of various stakeholder sectors) Health Canada-initiated meeting Launch of the stakeholder engagement process on technical issues related to PRCI implementation: introduce members, clarify purpose & operations of group, provide additional feedback on earlier consultation, and discuss proposed forward agenda for the group. Resource Management and Operations Directorate, Information Sciences and Openness Division; Office of the Chief Regulatory Officer
  1. Agenda (English)
  2. Presentation deck (English)
  3. Record of Discussion (English)
SRG2 2017-11-24 SRG2 - Implementation of PRCI - Overview of Operations and key implementation issues Health Canada, HPFB's Stakeholder Reference Group for Implementation of PRCI (representative body of various stakeholder sectors) Health Canada-initiated meeting To present an overview of the proposed operational framework and seek stakeholder reference group comments on key issues. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Agenda (English)
  2. Presentation deck (English)
  3. Record of Discussion (English)
SRG3 2018-01-11 SRG3 - Implementation of PRCI - protection of personal information Health Canada, HPFB's Stakeholder Reference Group for Implementation of PRCI (representative body of various stakeholder sectors) Health Canada-initiated meeting To discuss the proposed approach to protecting personal information within clinical information (e.g. obligations under the Privacy Act) and seek stakeholder reference group comments on related issues Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Agenda (English)
  2. Presentation deck (English)
  3. Record of Discussion (English)
SRG4 2018-02-15 SRG4 – Implementation of PRCI – specifying clinical information & safeguards against commercial use Health Canada, HPFB’s Stakeholder Reference Group for Implementation of PRCI (representative body of various stakeholder sectors) Health Canada-initiated meeting To introduce the proposed approach to applying regulations to specify the information that ceases to be confidential and can be publically released, and seek stakeholder reference group member comments on related issues. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Agenda (English)
  2. Presentation deck (English)
  3. Record of Discussion (English)
SRG5 2018-04-13 SRG5 - Implementation of PRCI – public release options and health system impacts Health Canada, HPFB’s Stakeholder Reference Group for Implementation of PRCI (representative body of various stakeholder sectors) Health Canada-initiated meeting To present options under consideration for the public portal for release of clinical information, as well as for monitoring and evaluating broader health system impacts, and to seek stakeholder reference group comments on related issues. Resource Management and Operations Directorate, Information Sciences and Openness Division
  1. Agenda (English)
  2. Presentation deck (English)
  3. Record of Discussion (English)

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