Meeting Highlights: Global Regulatory Sessions
Regulatory Affairs Around the World: Map Your Sessions at DIA 2017
Monday, June 19
The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India11:00AM-12:15PM
Panelists will use a case-study format and present the risk-based approach used to select sites for inspection and discuss the role of FDA’s international offices in facilitating inspections and engaging with regulatory counterparts in country.
This session will provide an overview of CFDA regulatory reform and an update on key important initiatives.
Tuesday, June 20
Panelists will provide an overview of how the Center for Biologics Evaluation and Research (CBER) works to advance the development of biological products such as vaccines, live biotherapeutics, and cellular and gene therapies.
Regulatory agencies from major East Asian countries including Japan, Singapore, and Taiwan, together with the industry representation, will give an overview of the recent regulatory environment changes in each country.
Learn how regulators have and are demonstrating a willingness to find new and pragmatic ways of working together with industry with the ultimate goal of providing health care solutions which are in high-demand by society.
PMDA’s executive staff will discuss progress made towards achieving the goals outlined in its “PMDA International Strategic Plan 2015”, as well as other initiatives currently underway and new initiatives to further PMDA’s contributions to global health.
Gain an overview of the current state of play of the political process from a UK as well as an EU perspective.
Wednesday, June 21
Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.
A panel of experts will discuss the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.
FDA and Health Canada will highlight their work under RCC Phase 2 and request stakeholder input on their current initiatives.
The expert panel will continue the discussion on the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.
Thursday, June 22
EMA and FDA leadership will engage in a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines.