As Director of the Phase 1 Unit of the Clinical Pharmacological Research Center at Peking Union Medical College, Dr. Pei Hu has been a driving force in advancing model-based drug development in China. Dr. Hu discusses recent changes impacting clinical research in China and her service as co-chair of our 10th DIA China Annual Meeting in Beijing.
The US Centers for Disease Control and Prevention estimates that the annual "economic burden" from prescription opioid abuse–including the costs of healthcare, lost productivity, addiction treatment, and criminal justice–is $78.5B. Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), US National Institutes of Health, discusses opportunities to turn back this tide and previews the Keynote Address she will deliver at our DIA 2018 Global Annual Meeting this June.
Dr. Shahid Hanif, Head of Health Data & Outcomes for the Association of the British Pharmaceutical Industry, discusses the IMI Big Data for Better Outcomes initiative in advance of the session Has the Time for Big/Real World Data Finally Arrived? which he will chair at DIA Europe 2018.
Patrick Brady, Vice President for Regulatory Policy & Intelligence at Bayer, discusses the impact of artificial intelligence on clinical and regulatory science professionals. Mr. Brady will moderate the panel discussion Exploring the Use of Artificial Intelligence: Trust in Technology, or Trust in Each Other? at DIA Europe 2018.
Dr. J. Vijay Venkatraman, India Regional Editor for Global Forum and Managing Director & CEO for Oviya MedSafe Private Limited (India), discusses the Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products in India, which came into effect January 2018, and the Pharmacovigilance Programme of India (PvPI).
Harmonizing clinical trial assessment and supervision in the EU through the portal and database established by the new EU Clinical Trial Regulation, and maintained by the EMA, is not the only change rippling through clinical trials in Europe, explain Dr. Mireille Muller, Regulatory Policy Director for Novartis A-G in Switzerland; and Dr. Greet Musch, Director-General for Pre-Authorisation at the Federal Agency for Medicines and Healthcare Products of Belgium. Dr. Muller and Dr. Musch will help lead discussions on this topic at DIA Europe 2018.
Maryll Toufanian, JD, Acting Director, US FDA Office of Generic Drug Policy, discusses the US FDA’s Drug Competition Action Plan, why US consumers can feel safe taking generic drugs, and how generic drugs can help reduce costs for healthcare patients and systems. Learn more at our Complex Drug-Device Generic Combination Products conference.
The World Health Organization recently estimated that, worldwide, more than 15 million people suffer from opioid dependence and roughly 69,000 people die from opioid overdoses each year. In this Global Forum podcast, Professor Edward Bilsky, an expert in opioid pharmacology and early-stage drug development who serves as the Provost and Chief Academic Officer at Pacific Northwest University of Health Sciences, discusses the importance of patient engagement in opioid pain management.
Dr. Ellen V. Sigal, Chairperson and Founder of Friends of Cancer Research, discusses the advocacy organization’s role in the Breakthrough Therapy designation in this Global Forum podcast. Dr. Sigal is also Chair of the Board of Directors of the Reagan-Udall Foundation, serves on the Board of the Foundation for the National Institutes of Health, and serves on the Cancer Moonshot Blue Ribbon Panel established by Vice President Joe Biden.
In this Global Forum podcast, Dr. Julie Gerberding (Chief Patient Officer and Executive Vice President for Policy, Communications, and Population Health, Merck) discusses the evolution of patient engagement and her service as former Director for the US Centers for Disease Control and Prevention, as an executive sponsor of the Merck Women’s Network, and as honorary co-chair for DIA Global 2018 in Boston.