DIA: Driving Insights to Action
Science:Life Sciences
Growing globalization of supply chains, patient recruitment and clinical trials has made cooperation among the world’s regulatory agencies more important than ever. In this exclusive Global Forum podcast, Dr. Sandra Kweder, Deputy Director in the FDA Office of International Programs’ Europe Office, and FDA’s Liaison to the European Medicines Agency, discusses regulatory collaboration in the modern health care product ecosystem. “My role specifically is to bring our two agencies together. That’s my job,” she explains. “My job operates at many levels. One is to provide someone onsite at EMA to help EMA understand FDA. We do the same things but our systems could not be more different. At the same time, my job is to observe EMA and try to translate EMA back to my FDA colleagues. Simply because we have arisen from different roots, we often approach the same thing from different angles.” Dr. Kweder will be featured speaker in several DIA 2017 Global Annual Meeting sessions.
Innovative Partnering Models and Outsourcing Strategies
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
Trends in Pharmaceutical Quality
Innovative Technology in Clinical Development
Interview with DIA Annual Meeting Co-Chair Dr. Michael Rosenblatt
Innovation in Vaccine Development
Implementing Innovation- Globally Conducive Regulatory Policies
Availability of Medicinal Products: Drug Shortages
Medical Devices and Combination Products
Pharmacovigilance in 2015- Poised for convergence of innovation
Spiros Vamvakas on Early Dialogue with Regulators
Detlef Niese on Translational Medicine
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