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Education Center of Excellence in Regulatory Science …

Details: Admission into Ph.D. programs. For more information, view the program website or contact Sharese Essien, Program Manager, MS in Regulatory Science at (410) 706-7241. Individuals who wish to learn more about the MS in Regulatory Science program at the University of Maryland, Baltimore and the Certificate program at the University of Maryland

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Non-Degree Graduate Program Center of Excellence in

Details: Education Non-Degree Graduate Program The science-driven Regulatory Science degree and non-degree programs are focused on drug and biologics product development and regulation, including aspects of diagnostics, devices, nutritional products, and worldwide regulatory principles.

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Workshops Center of Excellence in Regulatory Science and

Details: July 23-24, 2020. Topical Drug Development: Evolution of Science and Regulatory Policy II. November 12-14, 2019. Clinical Investigator Training Course: Regulatory Education for Industry. October 2, 2019. Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) September 23-25, 2019.

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Clinical Investigator Training Course Center of

Details: Nov 2017. The Clinical Investigator Training Course is designed for physicians, nurses, pharmacists and other healthcare professionals involved in clinical trials. Lectures are presented by senior FDA experts as well as guest lecturers from industry and academia explore …

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An Introduction to the Science of Clinical Outcomes

Details: The objective of the proposed project is to develop and deliver an online COA continuing-education (CE) series that provides an introduction to COA fundamentals in an accessible format. The COA CE series will be geared toward working professionals who seek …

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M-CERSI Scholars Center of Excellence in Regulatory

Details: M-CERSI Scholars. The M-CERSI Scholars program promotes doctoral candidates and postdoctoral fellows who seek to amplify their knowledge in regulatory science while completing training at the University of Maryland. In addition to their doctoral or postdoctoral training experience, M-CERSI Scholars benefit from participating in M-CERSI events

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Research Center of Excellence in Regulatory Science and

Details: Research. M-CERSI creates new mechanisms for scientific exchange, education and training, as well as regulatory science research. The center brings together diverse thoughts and ideas around emerging technologies and methodologies for regulatory science. The sum of these interwoven activities is a vibrant, cutting edge center that stimulates

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Regulatory Education for Industry Clinical Investigator

Details: Regulatory Education for Industry Clinical Investigator Training Course Below are slides from the Clinical Investigator Training Course held November 12-14, 2019, in Silver Spring, Maryland. To be alerted when registration for the 2020 course opens, please email [email protected] gov .

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Clinical Investigator Training Course: 2018 Center of

Details: Education; Clinical Investigator Training Course; Clinical Investigator Training Course: 2018; Clinical Investigator Training Course: 2018. Target Audience. This activity is intended for physicians, pharmacists, nurses, researchers and others who are responsible for the conduct of clinical trials.

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FDA Resources Center of Excellence in Regulatory Science

Details: FDA Resources. FDA's Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between FDA and academic institutions to advance regulatory science through innovative research, education, and scientific exchanges. Learn More.

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Regulatory Education for Industry Clinical Investigator

Details: Continuing Education SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

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Monthly Lectures Center of Excellence in Regulatory

Details: Vence Bonham, J.D. National Institute of Health Education and Community “Reducing Racial and Ethnic Health Disparities: Is Genomic Medicine the Path?" May 3, 2013 (86) Curtis Klaassen, Ph.D., University of Kansas Medical Center “New and Future Mechanisms of …

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Current State and Future Expectations of Translational

Details: experience in formulation development and biopharmaceutics through her education and training at the Food and Drug Administration (FDA, 2013-present); Virginia Commonwealth University (Ph.D. in Pharmaceutical Sciences, 2009-2013); Sun Pharmaceutical Advanced Research Company (Research Assistant in Formulation Development, 2006-2008), and Gujarat

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Research Projects Center of Excellence in Regulatory

Details: An Introduction to the Science of Clinical Outcomes Assessment (COA) A-COA Online Continuing- Education Series. The science of clinical outcomes assessment (COA) is of growing interest and has become important to medical product development. COA involves understanding the patient’s view of illness and treatment, and gathering how the patient

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Clinical Investigator Training Course: 2017 Center of

Details: Education; Clinical Investigator Training Course; Clinical Investigator Training Course: 2017; Clinical Investigator Training Course: 2017. Target Audience. This activity is intended for physicians, pharmacists, nurses, researchers and others who are responsible for the conduct of clinical trials.

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Events Center of Excellence in Regulatory Science and

Details: Featured Event Drug Permeability: Best Practices for BCS-based Biowaivers Monday, December 6, 2021 8:30 a.m.-4:15 p.m. Collaborative workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA) Biopharmaceutics Classification System (BCS) is a well-established scientific framework

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Regulatory Education for Industry (REdI) and CERSI Workshop

Details: Regulatory Education for Industry (REdI) and CERSI Workshop Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls September 23-25, 2019 College Park, MD

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Hacking Tomorrow's Tech World Center of Excellence in

Details: So does Ganesh, who feels it’s important to her engineering education and the education of her peers—both women and men—to see more women in the room. Technica is more than an extracurricular. “It provides a safe place to pursue your passion,” she says.

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Current State and Future Expectations of Translational

Details: SOCRA (The Society of Clinical Research Associates) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

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Barriers to Pediatric Clinical Trials: Patient/Caregiver

Details: Patient Education. Foundation’s Research on Clinical Trial Participation • Understand attitudes, knowledge, and beliefs regarding participation in an IBD clinical trial • Create resources to increase awareness, education, and support of clinical trials • Support enrollment and retention

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Collaborating to Advance Health Equity for Diabetes and

Details: community health education from University of Maryland, and a Master of Public Health from The George Washington University. Richard Knight, MBA President of the American Association of Kidney Patients (AAKP) Board of Directors Richard A. Knight is a former hemodialysis patient who received a

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Medical Device Innovation in Maryland: from Technology to

Details: dation for Advanced Education in the Sciences (FAES). Prior to joining Epidarex, he was the Program Manager for the Georgetown University Center for Drug Discovery. Mr. Miessau holds an M.S. in biotechnology and a B.S. in biochemistry from Georgetown University. Anita Nosratieh Food and Drug Administration, Center for Devices and Radiological

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FDA-Supported Center to Improve Drugs and Medical Device

Details: "Maryland's CERSI will draw from University of Maryland expertise on both the College Park and Baltimore campuses and create new mechanisms for scientific exchange, education and training, and regulatory science research," said William Bentley, the Robert E. Fischell Distinguished Professor of Engineering and founding chair of the Fischell

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Collaborating to Advance Health Equity for Diabetes and

Details: Access to culturally tailored diabetes education materials 36% 96% Adult weight management programs 19% 76% Nutrition services for children and youth 65% 90% Community-based physical activity programs for children and youth 13% 85% Physical activity programs for school-age youth 9% 83% 25.

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SPEAKER BIOGRAPHIES

Details: Education Center in Ethnogeriatrics to gain experience with developing educational programs to equip health care professionals to address the health care needs of culturally diverse older adults. Her practice, teaching and research expertise include geriatric pharmacotherapy, chronic …

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M-CERSI Final Report from Degree Programs in Regulatory

Details: and developed. Prior to the availability of a formal education in this field, regulatory training took place primarily “on the job,” was often narrowly focused, and left significant knowledge gaps. USC’s International Center for Regulatory Science is located on the Health Sciences campus along with the Keck medical school,

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In Vitro Dissolution Profiles Similarity Assessment in

Details: References: 1 Sandra Suarez-Sharp, M. Cohen, F. Kesisoglou, et. al. Applications of Clinically Relevant Dissolution Testing. AAPS J. 2018 Apr 9;20(3):60. 2 U.S. Department of Health and Human Services - Food and Drug Administration; CDER, Guidance for Industry - Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls; In Vitro

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Publications Center of Excellence in Regulatory Science

Details: 2017. Gaitonde P, Bozzi L, Shaya FT, “ Factors Associated with Use of Disease Modifying Agents for Rheumatoid Arthritis in the National Hospital and Ambulatory Medical Care Survey .”. Under review in Seminars in Arthritis and Rheumatism Semin Arthritis Rheum. 2017 Oct 18. pii: S0049-0172 (17)30463-8. doi: 10.1016/j.semarthrit.2017.10.011.

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BIOE Seminar: Ji-Xin Cheng Center of Excellence in

Details: Professor Cheng has been recognized by Fellow of Optical Society of America (2018), SPIE Translational Research Awards (2018, 2016, 2014), Purdue University College of Engineering Research Excellence Award (2016), Craver Award from Coblentz Society (2015), Chang-Jiang Scholar from Chinese Minister of Education (2015), Fellow of American

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Good Clinical Practice (GCP) Key Concepts

Details: • Should be qualified by education, training, and experience (and state licensure where relevant) • Must meet protocol specific requirements – A qualified Physician (or dentist) should be responsible for trial-related medical decisions and care – Recommend maintaining a list of qualified individuals and their delegated tasks www.fda.gov

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Research Capabilities Center of Excellence in Regulatory

Details: Research Capabilities. M-CERSI includes the College Park and Baltimore campuses of the University of Maryland. The Baltimore campus is focused on health, law, and human services. Six professional schools and a Graduate School confer the majority of health care professional degrees in Maryland each year. The College Park campus is a preeminent

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3D Cell Culture Models for Drug PK, Safety, Efficacy

Details: 3D Cell Culture Models for Drug PK, Safety, Efficacy Assessment. Cells; Cell Culture; Drugs; FDA; CERSI; The U.S. Food and Drug Administration (FDA) and the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) co-hosted the virtual “3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment” workshop on August 14, 2020.

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MSE Seminar Series: Megatrends for Materials Science and

Details: The 2016 Bernard Gordon Prize for Innovation in Engineering Education was awarded to WPI (Recipients: D. Apelian, K. Wobbe, A. Heinricher and R. Vaz). With his colleagues and students, he has founded 6 companies: Materials Strategies; Battery Resourcers; Melt Cognition; Kinetic Batteries, Solvus Ventures, and Solvus Global. www.mindyourmetal.com

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Sixth Annual Talent Competition Highlights Student

Details: Sixth Annual Talent Competition Highlights Student Innovation in Regulatory Science. regulatory science; cancer therapy; pharmacy; Pharmacy students Nam Nguyen and Laetitia N'Dri took top prize in this year's "America's Got Regulatory Science Talent" Competition, hosted by M-CERSI.

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Patient Advocacy Organizations as Partners in Clinical Trails

Details: Education •Mailing •Social media •Survey based recruitment •Client hand off to ensure connection. Clinical Trial #3. 168 participants: Took over a year to recruit Trial terminated 2200 participants: 1850 retained and in a 5 year follow up. Recruitment target reached. 2 arms:

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Analgesic Clinical Trial Designs, Extrapolation, and

Details: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Under Age 2. Wednesday, October 13, 2021 10:00 a.m.-2:00 p.m.

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"America's Got Regulatory Science Talent" Competition

Details: "America's Got Regulatory Science Talent" Competition. Friday, January 15, 2021 9:00 a.m.-11:00 a.m. Virtual via WebEx Ann Anonsen [email protected]

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Directory Center of Excellence in Regulatory Science and

Details: Gullapalli, Rao. Professor. Diagnostic Radiology and Nuclear Medicine. Core for Translational Research in Imaging at Maryland. Center for Metabolic Imaging and Therapeutics. University of Maryland, Baltimore. [email protected]

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Innovation Awards Center of Excellence in Regulatory

Details: Innovation Awards. In 2013-2014, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) awarded two Innovation Awards, and five Innovations in Minority Health Awards. M-CERSI Innovations in Minority Health Awards are similar to Innovation Awards and additionally aim to address racial and ethnic health

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Advancing the Development of Pediatric Therapeutics (ADEPT

Details: Advancing the Development of Pediatric Therapeutics (ADEPT 7) Wednesday, September 1, 2021 Ann Anonsen [email protected] Advancing the Development of Pediatric Therapeutics (Adept 7) Complex Innovative Trial Design

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Polli, James E. Center of Excellence in Regulatory

Details: Co-PI, M-CERSI Health Sciences Facility II Room 623, Baltimore, MD 21201 410-706-8292 [email protected]

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