Call for Applicants

Call for Applicants: Industry Task Force on Real-World Data for Post-Market Drug Evaluations

About the Post-Market Drug Evaluation Program

The Post-Market Drug Evaluation (PMDE) Program provides evidence to federal, provincial, and territorial decision-makers about drugs that have been approved and are broadly available to people in Canada. For additional information, please refer to the PMDE Program Overview.

Real-world evidence is a pillar of the post-market pharmaceutical space and may contribute to drug evaluations, particularly for drugs with limited clinical trial evidence available (e.g., drugs for rare diseases). Drug manufacturers collect real-world data (RWD), and many have expressed interest in sharing these data with health technology assessment (HTA) agencies and decision-makers. However, substantial work is needed to effectively operationalize the use of industry-collected RWD.

PMDE Industry Task Force

We are establishing a time-limited PMDE Industry Task Force to identify opportunities and barriers for using industry RWD in our PMDE Program, which will build on the recently released Guidance for Reporting Real-World Evidence. This group will be task-oriented and work collaboratively to develop an options paper for us that will advise on best practices and potential approaches for using industry RWD and identify ways to mitigate risks and barriers.

This task force will consist of 8 to 10 pharmaceutical industry delegates (including the PMDE Advisory Committee’s industry representatives), supplemented with representatives from Health Canada and us. The group will report directly to the multistakeholder PMDE Advisory Committee. Additional industry representation will come from recommendations provided by Innovative Medicines Canada (IMC) and BIOTECanada (4 to 6 members) and 2 others not affiliated with these 2 associations identified through this public call for applications.

Involvement Opportunity

We are currently recruiting these 2 representatives of pharmaceutical companies that are not currently affiliated with IMC or BIOTECanada to be part of this industry task force aimed at identifying ways to mitigate the risks and barriers for using industry RWD in the PMDE Program.

It is a time-limited opportunity; members will meet monthly for 90 to 120 minutes over the course of 5 months, with the possibility of extension. Members of the task force will be unpaid because they will be representing the industry that employs them. Applicants must be available for the following dates and times. Additional meeting dates will be discussed if needed.

• Meeting 1: September 26, 2023 (2:00 p.m. to 4:00 p.m. ET)
• Meeting 2: October 24, 2023 (2:00 p.m. to 4:00 p.m. ET)
• Meeting 3: November 28, 2023 (2:00 p.m. to 4:00 p.m. ET)
• Meeting 4: January 16, 2024 (2:00 p.m. to 4:00 p.m. ET)

Industry representatives who meet the requirements and bring experience within some of the following areas of expertise are encouraged to apply.

Requirements:

• Currently employed by a pharmaceutical company with presence in Canada that holds Canadian data
• Minimum of 10 years’ experience in the health care landscape with at least 3 years of experience in a pharmaceutical company
• Not employed by an organization that is affiliated with IMC or BIOTECanada

Areas of expertise:

• Familiarity with regulatory affairs, health policy, and health technology assessment
• Experience in the execution of evidence-generation projects, including methodology, protocol design, RWD collection and analysis, and reporting
• Understanding of research governance, laws, and ethics
• Well-connected within their organizations (locally and globally) and externally with strategic partners.

To apply, send your CV to [email protected] by August 31, 2023.