All posts tagged: Regulations

FDA Public Meeting: Rare Disease Day 2022

February 14, 2022
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FDA will host a virtual public meeting on March 4, 2022 to join the global observance of Rare Disease Day. The theme for FDA’s Rare Disease Day is “Sharing Experiences in Rare Diseases Together.” Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development.

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CAC2 Webinar–The Role of the IRB in Clinical Trials: What Patients and Families Need to Know — SLIDE DECK

September 22, 2017
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In this month's All-Member webinar, Joanne Salcido of the Pediatric Brain Tumor Foundation introduced and hosted Dr. Marjorie Speers of the WCG Foundation.  The slide deck from the presentation is linked below. Dr. Speers's presentation described the clinical trial process and the role of the IRB in phase 1 – 4 clinical trials. During her webinar, she explained the differences between academic and independent IRBs and the challenges IRBs face when they review multi-site trials. She also described the revised regulations that are likely to go into effect in 2018 and how they should help to reduce the time it takes for an [...] Read more

CAC2 Webinar–Basics of a Clinical Trial in Pediatrics: A Sponsor’s Perspective

August 19, 2016
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In this All-Member and all-community webinar for August 2016, CAC2 welcomes Drs. Michael Trigg, Brigid Bradley-Garelik, and Greg Plautz from Bristol-Myers Squib, speaking on the clinical trial process. These three esteemed industry experts provided an overview of the clinical trial process, particularly from an industry-sponsored trial perspective and cover topics such as clinical trial designs, different required FDA phases of drug development, data monitoring committees, general principles of pediatric trials and special considerations of pediatric trials, industry obligations to pediatrics and personalized medicine. This presentation was not recorded. Read more
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