Bilateral Meeting Program

Therapeutic Products Directorate
Health Products and Food Branch
Bilateral Meeting Program

The Therapeutic Products Directorate (TPD) hosts regular bilateral meetings with a number of national stakeholder organizations to discuss and consult on regulatory issues of mutual interest, exchange information, share expertise and, when appropriate, responsibilities. These organizations include those whose business is directly impacted by the regulation of pharmaceuticals and medical devices, e.g. industry and pharmacy associations.

The Bilateral Meeting Program supports TPD’s strategic commitment to build collaborative relationships and the Health Product and Food Branch’s key strategy to improve transparency, openness and accountability. If you wish to access the Records of Decisions please use this link:  Association Meetings.

Participants

TPD schedules regular meetings (1 to 2 times each per year) with the national stakeholder organizations listed below. Stakeholder groups interested in joining the BMP should submit a written request to the Director General.

Bilateral Meeting Program

  • Canada’s Medical Technology Companies (2)
  • Canadian Generic Pharmaceutical Association (2)
  • Groupement provincial de l’industrie du médicament (2)
  • Innovative Medicines Canada (2)
  • National Association of Pharmacy Regulatory Authorities (1)

BMP meetings often require participation from other HPFB Directorates as the regulatory system for evaluating and monitoring the safety, efficacy and quality of pharmaceuticals and medical devices covers a range of activities that fall under the responsibility of various Directorates. TPD strives to provide BMP stakeholder participants with a single window access to HPFB, and when required, other Health Canada organizations. Representation at BMP meetings is determined by the issues identified on the agenda.

Reporting Structure

The TPD Bilateral Meeting Program is managed by the  Office of Planning, Performance and Review Services (OPPRS) on behalf of the Director General.

Administration

Chair - Meetings are co-chaired by TPD's Director General or a delegate and a representative of the visiting stakeholder organization.

Meeting Schedule - A schedule of meetings for the calendar year is prepared each fall in coordination with the participating stakeholder organizations.

Secretariat - Secretariat functions are provided by TPD’s External Stakeholder Services and Contracting Unit (ESSCU), OPPRS.

Roles and Responsibilities

ESSCU

TPD’s Bilateral Meeting Program is administered by the External Stakeholder Services and Contracting Unit (ESSCU), OPPRS.

Responsibilities

  1. Liaise with HPFB and TPD BMP Networks and contact for each stakeholder organization
  2. Be the HPFB BMP Network contact for TPD
  3. Manage and circulate the yearly BMP Calendar and internal weekly updates
  4. Coordinate agenda development
  5. Determine the organizational leads responsible (i.e. TPD Bureau/Office, HPFB Directorate) for proposed agenda items
  6. Coordinate responses to agenda items
  7. Collect and distribute meeting documentation (i.e. agenda, agenda item summaries, supporting documents) for TPD preparatory and actual meetings
  8. Coordinate participation at meetings
  9. Provide logistical support for meetings
  10. Draft, finalize and post meeting notes on the Health Canada website
  11. Track BMP action items and provide progress updates to TPD Management Committee and stakeholder organizations

TPD BMP Network

The TPD BMP Network facilitates cross-Bureau/Office communication and coordination of bilateral meetings with stakeholder organizations. The Network consists of staff who serve as the primary point of contact for their respective Bureau/Office.

Responsibilities:

  1. Liaise with TPD's ESSCU
  2. Circulate the BMP Calendar within their Bureau/Office
  3. Distribute meeting documentation within their Bureau/Office
  4. Review agenda items to determine if their Bureau/Office's participation is required
  5. Identify Agenda Item Leads for items that fall within their Bureau/Office's responsibility
  6. Canvass their Bureau/Office for agenda items
  7. Coordinate their Bureau/Office's response to agenda items
  8. Coordinate their Bureau/Office's participation at meetings
  9. Coordinate their Bureau/Office's review of draft meeting notes
  10. Track and report their Bureau/Office's progress on action items

HPFB BMP Network

The HPFB BMP Network facilitates cross-Directorate communication and coordination of bilateral meetings with stakeholder organizations. The Network consists of staff who serve as the primary point of contact for their respective Directorate.

Responsibilities:

  1. Liaise with TPD's ESSCU
  2. Circulate the BMP Calendar within their Directorate
  3. Distribute meeting documentation within their Directorate
  4. Review agenda items to determine if their Directorate's participation is required
  5. Identify Agenda Item Leads for items that fall within their Directorate's responsibility
  6. Canvass their Directorate for agenda items
  7. Coordinate their Directorate's response to agenda items
  8. Coordinate their Directorate's participation at meetings
  9. Coordinate their Directorate's review of draft meeting notes
  10. Track and report their Directorate's progress on action items

Stakeholder Organization Contact

The stakeholder organization contact coordinates their organization's participation in BMP meetings.

Responsibilities:

  1. Liaise with TPD's ESSCU
  2. Circulate their BMP schedule within their organization
  3. Canvass their organization for agenda items
  4. Coordinate their organization's preparation of agenda items
  5. Distribute meeting documentation within their organization
  6. Coordinate their organization's participation at meetings
  7. Coordinate their organization's review of draft meeting notes
  8. Track and report their organization's progress on action items

Agenda Item Sponsor and Lead

The Agenda Item Sponsor is the person adding an item to the agenda. The Agenda Item Lead is the person operationally responsible for the agenda item. For HPFB, this would typically be a director or manager.

Responsibilities:

  1. Liaise with TPD's ESSCU Unit and, for HPFB Agenda Item Sponsors or Leads, with their BMP Network contact
  2. If applicable, collaborate with others involved in the agenda item and coordinate a response
  3. Complete an Agenda Item Summary (AIS), Section 1 for a Sponsor, Section 2 for a Lead (Appendix 1)
  4. Attend or send a delegate to the meetings (preparatory and actual) and be prepared to discuss and respond to the agenda item
  5. Review the draft meeting notes for their agenda item
  6. Follow-up on action items

Meeting Process

  1. Eight to ten weeks before the scheduled meeting, TPD requests the stakeholder organization to submit their proposed agenda items and list of meeting participants. For each agenda item, the Agenda Item Sponsor completes Section 1 of the Agenda Item Summary. Completed AISs with supporting documentation such as correspondence and reportsFootnote *, are provided to TPD four weeks before the meeting date. The status on any outstanding action items from the previous meeting is also provided at this time.

  2. TPD reviews the AISs for clarity and completeness. The stakeholder organization may be requested to provide additional information. Based on the AISs, the draft Agenda (Appendix 2) is prepared.

  3. Two weeks before TPD's prescheduled preparatory meeting, the draft Agenda and AISs are sent to the BMP Networks. Additional agenda items are also solicited at this time. For each agenda item, the relevant Agenda Item Lead reviews the AIS and completes Section 2. The stakeholder organization may be requested to provide additional information.

  4. One week before TPD's preparatory meeting, the BMP Networks provide TPD's ESSCU with the completed AISs (revised and new), the status on any outstanding action items from the previous meeting and a list of participants.

  5. Approximately two days before the preparatory meeting, TPD's ESSCU provides the BMP Networks with the draft Agenda, AISs and any supporting documentation.

  6. Two weeks before the meeting with the stakeholder organization, TPD holds a preparatory meeting with the Director General (or a delegate) and the Agenda Item Leads and Sponsors to discuss the draft Agenda and AISs, add or removeFootnote 1 agenda items, review any outstanding actions from the previous meeting, and confirm the participants for the meeting.

  7. Following the preparatory meeting, the stakeholder organization may be requested to provide additional information. AISs may need to be revised or created by Agenda Item Leads or Sponsors.

  8. The final AgendaFootnote 2 and AISs with supporting documentation are distributed to all confirmed participants and the BMP Networks no later than three days before the meeting.

  9. Within six weeks after the meeting, the meeting notes are prepared by TPD and posted on the Health Canada website. The meeting notes provide a summary of the issue and discussion but more importantly capture any agreed upon actions. Action items should indicate what is to be done, who is to do it and by when it is to be completed. The process includes three weeks to draft the meeting notes and have Agenda Item Leads validate that they accurately reflect the discussion and action items; one week to seek validation from the stakeholder organization; one week for translation and a review by HPFB's Access to Information (ATI) Office against the conditions of the ATI Act; and, one week to obtain approval from TPD's Director General, distribute to all participants and request website posting.

  10. On an on-going basis, TPD's ESSCU tracks all action items in the BMP Actions Report and provides progress updates to the stakeholder organizations and BMP Networks. Stakeholder organizations are responsible for providing TPD with progress updates on their actions. The report highlights outstanding actions and is provided quarterly to TPD's Directorate Management Committee.

Definitions

BMP Agenda Item Summary -
aims to provide clarity on agenda items; help identify the appropriate agenda item lead; assist with preparing a response in advance of the meeting; facilitate the meeting discussion; and, improve overall meeting management.
BMP Actions Report -
is a roll-up of all actions resulting from meetings with stakeholder organizations. The report improves tracking and accountability on commitments.
Stakeholder -
an individual, group, or organization that is affected by or interested in an issue or policy. Stakeholders, interested parties, and affected parties are segments of the public. Stakeholders may include health professionals, academia, industry, and patients.
Openness -
is inviting, hearing, considering and sharing of information in the conduct of the Health Product and Food Branch's business.
Transparency -
is facilitating access to and understanding of the information and processes the Health Products and Food Branch uses to conduct its business. 

Sample Agenda Item Summary

Therapeutic Products Directorate
Health Products and Food Branch
Bilateral Meeting Program

  • Agenda Item Summary - Item #
  • Association:
  • Agenda Item Title : [insert agenda item title]
  • Time Required: [time required for presentation and discussion]
  • Meeting Date:
  • Check one:
    • For update
    • For information
    • For direction
    • For decision

Section 1 - To be completed by organization tabling the agenda item

  • Agenda Item Sponsor : [insert name and title of person tabling agenda item]
  • Presenter(s)/Attendees : [insert name of person(s) who will present agenda item on behalf of or with the agenda item sponsor]
  • Issue/Background : [describe the issue(s) and provide any relevant background information]
  • Supporting Documents: [list documents (references or attachments) that support this agenda item - may be provided by either organization]
  • Desired Outcome: [provide what the expected result is from the discussion of this agenda item - e.g. to obtain or provide update, direction, clarification, decision, raise awareness on...]

Section 2 - To be completed by organization responding to the agenda item

  • Agenda Item Lead: [insert name, title, office of person(s) responsible for this agenda item - for Health Canada, this would be the director or manager]
  • Respondent(s)/Attendees : [insert name of person(s) who will respond to the agenda item on behalf of or with the agenda item lead]
  • Status: [provide the draft response or update to facilitate preparatory and actual meeting discussions for this agenda item]

Section 3 - Discussion Notes & Action

MAKE SURE EVERYONE IS CLEAR ON ANY RESULTING ACTIONS - what is to be done, who is doing it and by when it is to be completed.

Sample Draft Agenda

Therapeutic Products Directorate
Health Products and Food Branch
Bilateral Meeting Program

  • Draft Agenda
    • Association
    • Location
    • Date
    • Start Time
    • End Time
  • Time
  • Item number
  • Agenda Item Title
  • Type
  • Sponsor(s)

Agenda Item # 1: Welcome and introductions, Type**, Sponsor(s)

Agenda Item # 2: Review of agenda, Type**, Sponsor(s)

Agenda Item # 3: Review of previous action items (dated…), Type**, Sponsor(s)

Type**: A - Administration, U - Update, I - Information, Dir - Direction, Dec - Decision

  • Future Agenda Items
    • Agenda item title (sponsor's name)
  • Health Canada Participants
    [list names]
  • Association Participants
    [list names]

TPD's Bilateral Meeting Program Process

Text Description - Therapeutic Products Directorate’s (TPD's) Bilateral Meeting Program Process

Bilateral Meeting Program Meeting Calendar

8-10 weeks before meeting

(6-8 weeks before TPD prep meeting)

TPD External Stakeholder Services and Contracting Unit (ESSCU) requests Agenda Item Summaries (AISs) and participant list from stakeholder organization.

4 weeks before meeting

(2 weeks before TPD prep meeting)

Stakeholder organization submits Agenda Item Summaries

ESSCU reviews Agenda Item Summaries for quality and clarity. Stakeholder organization may be requested to provide more information.

ESSCU sends Agenda Item Summaries to Therapeutic Products Directorate and Health Products and Food Branch Networks for completion by Agenda Item Leads, calls for new agenda items and preparatory meeting participants.

3 weeks before meeting

(1 week before TPD prep meeting)

Bilateral Meeting Program (BMP) Networks return completed Agenda Item Summaries (revised and new) and provide status on previous meeting’s actions toESSCU.

2 weeks before meeting

Therapeutic Products Directorate holds preparatory meeting with Agenda Item Leads to review agenda, Agenda Item Summaries and status of outstanding actions; identify new agenda items; confirm meeting participants.

Stakeholder organization may be requested to provide more information and/or final supporting documentation, confirm participants.
Agenda finalized and Agenda item Leads revise Agenda Item Summaries as needed, stakeholder organization notified of any changes in agenda.

3 days before meeting

ESSCU sends meeting documentation to stakeholder organization, confirmed Therapeutic Products Directorate / Health Products and Food Branch participants and Bilateral Meeting Program Networks.

Bilateral Meeting Program held

6 weeks after meeting

ESSCU has drafted meeting notes and had them reviewed by all participants* and Health Products and Food Branch Access to Information Office (ATI), translated, approved, distributed and posted on Health Canada website.

*Stakeholder organization (Stakeholder Organization Action) has also reviewed draft notes.

On-going

ESSCU tracks all Bilateral Meeting Program action items and provides progress updates to stakeholder organization, Bilateral Meeting Program Networks, and Therapeutic Products Directorate Management Committee. Stakeholder organization tracks their Bilateral Meeting Program Action items and provides progress updates to Therapeutic Products Directorate.

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