| DATE / TITLE | MEETING HOST | REGISTERED | ATTENDED |
|
November 16, 2018 Pediatric Inflammatory Bowel Disease (IBD) Event Materials |
Dr. James Polli | ** | ** |
|
October 3-4, 2018 Predictive Immunogenicity for Better Clinical Outcomes Event Materials |
Dr. James Polli | ** | ** |
|
October 27, 2017 Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design and Endpoints Event Info & Registration |
Dr. James Polli | ** | ** |
|
May 15-17,2017 Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development  Final Report |
Dr. James Polli | 250 | 281 (3 days) |
|
April 17, 2017 MAMNA 2017 Symposium-Small Sensors Going Big Places Final Report (.pdf) |
Dr. Didier Depireux | 80 | 72 |
|
March 7, 2017 Medical Device Innovation in Maryland Program (.pdf) | Final Report |
Dr. William Bentley | 135 | 118 |
|
January 27, 2017 America's Got Regulatory Science Talent Competition Final Report |
Dr. James Polli | 25 | 25 |
|
December 5, 2016 Protein Aggregation Measurement in Biotherapeutics: Established and Emerging Techniques Final Report (.pdf) |
Dr. Bruce Yu Dr. Ewa Marszal |
130 | 94 |
|
September 23, 2016 Pediatric Master Protocols Final Report (.pdf) |
Dr. Jill Morgan Dr. Gil Burckart |
276 | 499* |
|
June 8 & 9, 2016 Formulation Science and Strategy to Facilitate Development of Pediatric Drug Products Final Report (.pdf) |
Dr. James Polli Dr. Jian Wang |
85 | 75 |
|
June 1, 2016 Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics Final Report (.pdf) |
Dr. Lily Mulugeta | 800 | 702 |
|
March 25, 2016 Material Advantage: Pioneering Devices Enabled by Material Breakthroughs Final Report (.pdf) |
Dr. Didier Depireux | 75 | 71 |
|
March 24, 2016 Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness Final Report (.pdf) |
Dr. Fadia Shaya Dr. Gregory Pappas |
213 | 153 |
|
February 5, 2016 "Americas Got Regulatory Scient Talent Competition" Final Report (.pdf) |
Dr. William Bentley Dr. James Polli |
29 | 29 |
|
September 11, 2015 Exploring Mobile and Social Media Informatics for Regulatory Decision-making: Methods, Opportunities and Challenges Final Report (.pdf) |
Dr. Ritu Agarwal | 118 | 84 |
|
August 21, 2015 Evidentiary Consideration for Integration of Biomarkers in Drug Development, Co-sponsored with Critical Path Institute (C-Path) Final Report (.pdf) |
Dr. Shashi Amur Dr. Ruth Barratt Dr. Jia Bei Wang |
521 | 329 |
|
June 5, 2015 Mass Spectrometry Imagery Analysis System for Medical Applications Final Report (.pdf) |
Dr. David Kilgour Dr. Michael Boyne |
54 | 37 |
|
May 4, 2015 Using Big Data to Inform Drug Safety and DER: Novel Solutions to Reduce Confounding in Administrative Databases Final Report (.pdf) |
Dr. Fadia Shaya Judy Staffar Simone Pinheiro Dr. Efe Eworuke |
162 | 263 |
|
April 6, 2015 Low Budget/High Payoff: Techniques and Resources for Innovative Micro/Nano Research Johns Hopkins Final Report (.pdf) |
Dr. Didier Depiereux | 78 | 69 |
|
March 9, 2015 Patient Focused Drug Development Final Report (.pdf) |
Dr. Eleanor Perfetto Elisabeth Oehrlein Theresa Mullin Ashley Slagle Pujita Vaidya Dr. Sara Eggers |
228 | 162 |
|
January 30, 2015 “America Got Regulatory Science Talent” competition |
Dr. James Polli | 24 | 23 |
|
January 22, 2015 Pediatric Drug Development: How can Exposure Matching and Exposure-Response be Utilized to Improve Pediatric Study Programs? Final Report (.pdf) |
Dr. Jill Morgan Dr. Lily Mulgeta Robert Nelson Kevin Krudys Jian Wang |
218 | 437 |
|
December 13-16, 2014 2014 TERMIS-Americas (TERMIS-AM) Conference & Exhibitions: TERMIS-AM Industry Committee One-Day event with the FDA |
Dr. John P. Fisher | 900 | 850 |
|
December 2, 2014 The Role of Standards and Regulatory Science in the Characterization of Biopharmaceuticals Final Report (.pdf) |
Dr. Marueen Kane Dr. David Goodlett Dr. Michael Boyne Ann Gray Waters |
50 | 45 |
|
June 20, 2014 Top Down Analysis of Antibodies Final Report (.pdf) |
Dr.Young Ah Goo Dr. David Goodlett |
80 | 64 |
|
May 21, 2014 Standards for Phantoms for Optical Medical Imaging Final Report (.pdf) |
Dr. Yu Chen | 69 | 58 |
|
May 12, 2014 Questioning the Bioequivalence Standards for Antiepileptic Drugs: Implications for Regulations of Narrow Therapeutic Index Drugs Final Report (.pdf) |
Dr. Tricia Ting | 76 | 82 |
|
May 5, 2014 Innovative Approaches to Pediatric Drug Development and Pediatric Medical Counter Measures: A Role for Physiologically-Based PK? Final Report (.pdf) |
Dr. Thomas Dowling Dr. Jian Wang Dr. Gilbert Burckart |
98 | 245 |
|
April 8, 2014 MALDI Mass Spectrometry Imaging of Drug Metabolism Final Report (.pdf) |
Dr. Maureen Kane | 61 | 53 |
|
March 6 & 7, 2014 AIMBE/NIH Workshop on Validation and Qualification of New in Vitro Tools and Models for the Pre-clinical Drug discovery Process Final Report (.pdf) |
Dr. William Bentley | 300 | 250 |
|
March 10, 2014 Regulatory Aspects of Micro/Nanosystems Technologies Applied Away from the Central Lab Final Report (.pdf) |
Dr. Ian White | 95 | 73 |
|
February 11, 2014 Leveraging Big Data II-What does it Mean for Improving Product Development and Health Care? Final Report (.pdf) |
Dr. Eleanor Perfetto | 95 | 80 |
|
January 30, 2014 “America Got Regulatory Science Talent” competition UMB Final Report(.pdf) |
Dr. James Polli | 25 | 23 |
|
September 12, 2013 Leveraging Big Data in Support of Outcomes Research: A Community Focus on the Potential for Medicine Final Report (.pdf) |
Dr. Eliot Siegel | 45 | 32 |
|
September 5, 2013 CERSI Day Year 2 Final Report (.pdf) |
Dr. William Bentley Dr. James Polli |
182 | 85 |
|
September 3, 2013 Regulatory Issues in Personalized Medicine and Pharmacogenomics Final Report (.pdf) |
Dr. Alan Shuldiner | 106 | 81 |
|
August 26, 2013 Human Reliability Analysis Applied to Medical Device Use-Related Hazards Final Report (.pdf) |
Dr. Monifa Vaughn-Cooke | 35 | 15 |
|
May 23, 2013 Control Strategies for Pharmaceutical Manufacturing: Real Time Release Testing (RTRT) and Design Space Determination Final Report(.pdf) |
Dr. Stephen Hoag | 65 | 51 |
|
May 21, 2013 Topical Bioequivalence and Bioavailability Summit Final Report (.pdf) |
Dr. Audra Stinchomb | 64 | 50 |
|
May 8, 2013 Workshop on Improved Characterization of Mesenchymal Stem Cell for Clinical Trials Final Report (.pdf) |
Dr. Curt Civin Dr. Steven Bauer |
121 | 115 |
|
April 15, 2013 Degree and Educational Programs in Regulatory Science or Regulatory Affairs Final Report (.pdf) |
Dr. Dr. Keith Herold Dr. James Polli |
49 | 35 |
|
March 14 & 15, 2013 AIMBE/NIH Workshop on Validation and Qualification of New In Vitro Tools and Models for The Pre-clinical Drug Discovery Final Report (.pdf) |
Dr. William Bentley | 170 | |
|
December 17, 2013 CERSI Scientific Exchange Meeting |
Dr. William Bentley Dr. James Polli |
50 | 40 |
|
September 2012 CERSI Day Year 1 Final Report (.pdf) |
Dr. William Bentley Dr. James Polli |
173 | 145 |
Total Attendees: 5103
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