WS-03 - Big Data in Health and Bioethics: A Call for a Comprehensive, Multi-disciplinary, ISPE Position
Location: WS-03
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Monday, Aug 23rd
1:45 PM - 3:30 PM US Eastern Time
OP-22A - Risk of Myocardial Infarction, Stroke or Death in New Users of Intravitreal Aflibercept versus New Users of Intravitreal Ranibizumab: A Nationwide Cohort Study
Location: OP-22
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
8:30 AM - 10:00 AM US Eastern Time
PLEN-2 - Plenary Session: Communicating COVID-19 Pharmacoepidemiological Research to Patients: Why Is It Important? How Can We Do It? what Are the Implications Now and for the Future?
Location: PLEN-2
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
1:45 PM - 3:30 PM US Eastern Time
OP-25D - Jak Inhibitors and the Risk of Cardiovascular and Venous Thromboembolism Events Among Patients with Rheumatoid Arthritis: A Network Meta-analysis of Clinical Trials
Location: OP-25
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04A - A Scoping Review of Key Use Cases for Artificial Intelligence to Reduce the Frequency of Adverse Drug Events
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04B - Awareness of Isotretinoin Use and Saudi FDA Pregnancy Prevention Program in Riyadh, Saudi Arabia: A Cross-sectional Study Among Female Patients
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04C - Evaluating Physician Knowledge of Risks and Safe Use of Rivaroxaban
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04E - Efficacy and Safety of Isoniazid Preventive Therapy (IPT) in People Living with Hiv: A Systematic
review and Meta-analysis
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04F - Effectiveness of Direct Healthcare Professional Communication for Concentrated Insulin Lispro (U-200 Kwikpen) in France, Germany, and Sweden
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04G - Dermatologists Awareness and Compliance with Saudi FDA Isotretinoin Pregnancy Prevention Program in Saudi Arabia: A Cross-sectional Study
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04H - Saudi Fda-approved Risk Minimization Measures: A Descriptive Overview
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP04J - Longitudinal Evaluation of U.S. REMS Program Modifications (2008–2020)
Location: SP04
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
3:30 PM - 4:45 PM US Eastern Time
SP05C - Non-interventional Post-authorization Safety Studies and Post-authorization Effectiveness Studies for Oncology Drugs: A Systematic Review
Location: SP05
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
5:15 PM - 6:30 PM US Eastern Time
SP14H - Prenatal Exposure to Teratogenic Medications in the Era of Risk Evaluation and Mitigation Strategies (REMS)
Location: SP14
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
6:45 PM - 7:45 PM US Eastern Time
L-3A - Gender Differences in Valproic Acid Use for Approved Indications in the United States (2017-2018) – an Opportunity for Risk Mitigation?
Location: L-3
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
6:45 PM - 7:45 PM US Eastern Time
L-3B - Missingness in Real World Data Submitted for Regulatory Decision-making: Eastern Cooperative Oncology Group Performance Status Case Study
Location: L-3
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
6:45 PM - 7:45 PM US Eastern Time
L-3C - Association of Statin Use with Dry Eye Disease
Location: L-3
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Tuesday, Aug 24th
8:00 PM - 9:30 PM US Eastern Time
PLEN-2B - REPEAT: Communicating COVID-19 Pharmacoepidemiological Research to Patients: Why Is It Important? How Can We Do It? what Are the Implications Now and for the Future?
Location: PLEN-2B
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Wednesday, Aug 25th
3:00 PM - 4:30 PM US Eastern Time
OP-8A - Impact of Fda’s Regulatory Actions on the Quality of REMS Survey Methodology Protocols (2007 – 2020)
Location: OP-08
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Wednesday, Aug 25th
3:00 PM - 4:30 PM US Eastern Time
OP-8C - Preferences Concerning Drug Safety Communication of Hospital-based Specialist in the Netherlands
Location: OP-08
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Wednesday, Aug 25th
3:00 PM - 4:30 PM US Eastern Time
OP-8D - Regulatory Approval of Phentermine/topiramate for Obesity Management and Off-label Use of Topiramate: A Fairytale for Drug Repurposing and a Maze for Risk Mitigation
Location: OP-08
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
Wednesday, Aug 25th
3:00 PM - 4:30 PM US Eastern Time
OP-8E - What Matters to Patients When Considering Treatments for Prevention of Rheumatoid Arthritis: A Preference Study in the United Kingdom, Germany, and Romania
Location: OP-08
Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
