Association Meetings: Biologic and Radiopharmaceutical Drugs Directorate
The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) hosts 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 biologics, radiopharmaceuticals, etc. (e.g. industry associations).
The Bilateral Meeting Program (BMP) supports BRDD's strategic commitment to build collaborative relationships and the Health Product and Food Branch's (HPFB) key strategy to improve transparency, openness and accountability.
Records of Decisions are available upon request from the BRDD at: hc.brddbmp-prbdmbr.sc@canada.ca
Participants
BRDD schedules meetings with the national stakeholder organizations listed below. Stakeholder groups interested in joining the BMP should submit a written request to the Director General.
- BIOTECanada Biologics Regulatory Affairs Group (BRAG)
- BIOTECanada Vaccine Industry Committee (VIC)
- Nuclear Medicine Alliance (NMA)
Canadian Association of Nuclear Medicine – Canadian Association of Radiopharmaceutical Scientists (CANM-CARS) - Biosimilars Canada
- Canadian Biosimilars Forum
- Blood Establishments (Non Commercial)
- Blood Establishments (Commercial)
BMP meetings often require participation from other HPFB Directorates as the regulatory system for evaluating and monitoring the safety, efficacy and quality of drugs covers a range of activities that fall under the responsibility of various Directorates. BRDD strives to provide stakeholder participants with a single window access to HPFB, and when required, other Health Canada organizations. Representation at bilateral meetings is determined by the issues identified on the agenda.
Reporting Structure
The BRDD Bilateral Meeting Program is managed by the Director of the Business Integration (OBI) on behalf of the Director General.
Administration
- Chair - Meetings are co-chaired by BRDD's Director General or a delegate and a representative of the visiting stakeholder organization.
- Meeting Schedule - A schedule of meetings is prepared each spring and fall in coordination with the participating stakeholder organizations.
- Secretariat - Secretariat functions are provided by the Office of Business Integration (OBI).
Contact Information:
Bilateral Meeting Program
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Email: hc.brddbmp-prbdmbr.sc@canada.ca