Sessions Will Focus on Ways to Embrace the Evolving Drug Development and Regulatory Environment
DIA will host the Annual Canadian Meeting: New Realities/New Frontiers from Oct. 29 to 30 at the Ottawa Marriott Hotel, bringing together worldwide leaders in regulation, industry, research and patient advocacy to discuss how the progress being made in patient-centered care can be translated into change in the drug development pipeline and regulatory processes.
Sessions will be devoted to the challenges faced by industry and regulators, the impact of global collaboration, and the need to provide patients and clinical professionals with increased access to drug information.
“New advancements such as novel products and technologies and personalized medicine models and cell therapies call for innovations in Canada’s regulatory landscape to maximize benefit to the patient,” said Barbara Lopez Kunz, global chief executive of DIA. “The meeting will explore how patients, health care professionals, industry and regulators can embrace these changes while placing patient safety and greater access to drugs at the forefront of their work.”
Kathryn McDade, assistant deputy minister of Health Canada’s Health Products and Food Branch, will deliver the opening remarks, followed by the plenary debate, “International Regulatory Cooperation: Trends and Impacts.” The session will focus on the impact of international cooperation on public policy and drug regulation, and highlight key initiatives that encourage interagency collaboration.
The Annual Canadian Meeting sessions include:
- Stakeholder Perspective,Oct. 29, 11 a.m.: As the industry seeks to bring products to global markets with a unified approach to research and development, companies face national laws and diversified regulatory requirements. The session will provide insight into the involvement of stakeholders in the regulatory harmonization process. Chanez-Narimene Kebache, manager of pharmacovigilance in Canada for Mallinckrodt Pharmaceuticals, will lead the session with key representatives from Health Canada and AstraZeneca, as well as patient advocates.
- IT Modernization, Oct. 30, 8:30 a.m.: Chaired by Paul Litowitz, associate director of the Bureau of Metabolism, Oncology and Reproductive Sciences, Therapeutic Products Directorate, Health Canada, the session will present the overall features of information technology modernization in the areas of website, e-signature and other electronic gateway platforms for market authorization and clinical trials.
- It’s BIG and It’s Coming, Oct. 30, 1 p.m.: Presented by Karen Feltmate, president of Redstone Health Group Inc., and representatives of Health Canada’s Therapeutic Products Directorate, the session will address significant imminent changes for the industry and regulators alike, focusing on topics such as strategic risk management, class-action lawsuits and patient home care.
To find out more about the event and to register, visit DIA’s Annual Canadian Meeting website
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org