News & Events
News & Events
June 22, 2018
2018 Clinical Outcome Assessments in Cancer Clinical Trials WorkshopWHAT: 2018 Clinical Outcome Assessments in Cancer Clinical Trials Workshop WHEN: June 22, 2018 WHERE: FDA White Oak Campus, Silver Spring, MD CONTENT: This full day workshop is sponsored by the FDA Oncology Center of Excellence and will consist of four panels made up of international regulatory, payer, academic, patient, industry and policy leaders. Initial agenda planning is...
April 25, 2018
Ninth Annual Patient-Reported Outcome Consortium WorkshopWHAT: Ninth Annual Patient-Reported Outcome Consortium Workshop WHEN: April 25-26, 2018 WHERE: Sheraton Silver Spring, Silver Spring, MD CONTENT: The Ninth Annual Patient-Reported Outcome Consortium Workshop will be on Wednesday, April 25 and Thursday, April 26, 2018 at the Sheraton Silver Spring, in Silver Spring MD. A detailed agenda and logistics are currently being developed and...
April 11, 2018
2018 Annual International Neonatal Scientific WorkshopYou are cordially invited to participate in the 2018 Annual International Neonatal Scientific Workshop at the Bethesda North Marriott Hotel and Conference Center on April 11th and 12th, 2018. Workshop participants will consider the role for ‘Real-World Evidence’ on medical product development for neonates, examine the regulatory implications of nutritional influences on outcomes of preterm...
March 14, 2018
Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin
Patel N, Hatley O, Berg A, Romero K, Wisniowska B, Hanna D, et al. Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin. AAPS J. 2018 May 1;20(3):47.
March 8, 2018
Quantitative Approach for Cardiac Risk Assessment and Interpretation in Tuberculosis Drug Development
Polak S, Romero K, Berg A, Patel N, Jamei M, Hermann D, et al. Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development. J Pharmacokinet Pharmacodyn. 2018 Mar 8;1–11.