DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally for The Well-Being of the Patient

The session’s objectives is to present the challenges of using the statistics from the drug development plan across the lifecycle of the product. Clinical development plans are geared towards product approval in a given region and are based on the health authorities’ requirements and international standards. In Canada, these statistical measures will be used to demonstrate the benefit of the drug to various decision-makers at the national and provincial level and also with prescribers. In large multinational companies these data may (or may not) fit the needs of the Canadian environment in the pre-market and post-market phase. The speakers will include a Health Canada perspective on evaluating statistical evidence generated at an international level to a Canadian context, an industry talk on interfacing with the various stakeholders to ensure alignment of need for informed decision-making, and from an advertising review agency on how best to use the stats you have to communicate the benefits of the drug to a healthcare professional.