The DIA 2012 48th Annual Meeting convened an unprecedented panel that included Dr. Margaret Hamburg, FDA Commissioner; Paul Glover, Assistant Deputy Minister, Health Products & Food Branch, Health Canada; and Dr. Guido Rasi, Executive Director, European Medicines Agency (EMA).
The three regulatory heads discussed ways to harmonize technical requirements under the ICH; establish confidentiality arrangements; collaborate on inspection pilots; exchange working level scientific and regulatory policies, procedures, and reports; and implement technical level "clusters" of agency reviewers.
Dr. Hamburg stressed the importance of streamlining and modernizing regulatory science, which brings together many supporting sciences (statistics, chemistry, etc.) and assembles them to support final regulatory judgment.
“In the interests of our own mission, we need to create a much more explicit framework for collaboration with our global partners,” she explained.
Mr. Glover explained the two foundational theses and three basic priorities for Health Canada: to remain true to the evidence as a science-based organization and to become more transparent in operating upon that premise. Its priorities are to employ the brightest minds to keep up with changes in science and industry; operational excellence; and regulatory modernization, which he further broke down into two aspects, proportional oversight and moving from being a domestic to an international agency.
Dr. Rasi noted that the challenges he and Mr. Glover face are substantially the same. He summarized his view of regulatory collaboration in two key words: trust and role.
According to Dr. Hamburg, all three agencies face the same economic restraints, operate in political systems, and deal with global products from complicated and geographically dispersed supply chains.
“We share a common goal throughout our work: to advance human health and safety,” she said. “Clearly, we need to create a broader integration of global regulatory activities.”
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China. www.diahome.org
Contact: Joe Krasowski