Clinical Pharmacology Considerations for Novel Therapeutic Modalities - Webinar
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Clinical Pharmacology Considerations for Novel Therapeutic Modalities - Webinar
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FDA CDER Small Business and Industry Assistance (SBIA)
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Clinical Pharmacology Considerations for Novel Therapeutic Modalities - Webinar
FDA CDER Small Business and Industry Assistance (SBIA)
FDA CDER Small Business and Industry Assistance (S...
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Category Selection:
Select any categories from those you have selected for your main listing. If you wish to include more categories, add them to your main listing first and after doing so, they will appear below.
Clinical Research *
Clinical Reporting
10
Abstract & Poster Development
3
Clinical Study Report Writing
8
Manuscript Development
1
Product Development
223
Analytical Methods Development
3
Clinical Research
133
Clinical Research Network Development
1
Clinical Trial Material Supply
3
Clinical Trials
85
Show More (4)
Document Management
7
Drug Product Manufacturing
4
Formulation Development
1
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Show Less (4)
Real World Data Research
36
Analytics Methods Development
10
Data Standardization & Curation
11
Evidence Prioritization
1
Late Phase Data Curation
7
Lifecycle Evidence Generation
2
Show More (2)
Observational Research
14
Real World Evidence
0
Show Less (2)
Study Operations & Management
114
Patient Recruitment
21
Site Contracting & Payments
2
Site Identification & Activation
11
Site Relationship Management
2
Study Tracking & Analytics
79
Show More (1)
Trial Implementation
1
Show Less (1)
Trial Design & Planning
67
Data Management Planning
7
Enrollment Analytics
3
Patient Recruitment Planning
43
Protocol Feasibility Planning
8
Software
2
Show More (1)
Statistical Analysis Planning
6
Show Less (1)
Commercialization *
Brand Planning & Activation
14
Brand Vision & Positioning
7
Campaign Concept Testing
1
Multi-Channel Campaign Launch
6
Customer Engagement
45
Omnichannel Optimization
13
Patient Engagement
3
Patient Facing Solution Design
16
Patient Journey Analysis
6
Retention Program Effectiveness
9
Show More (1)
Strategic Account Management
1
Show Less (1)
Finance & Investment *
Financial Services
7
Billing & Reporting Operations
3
Internal Audit Support
0
Investment Performance Analytics
3
Revenue Forecasting & Planning
1
Investment Banking
6
Buy & Sell Side Advisory
3
Capital Raising & Financing
4
Investor Relations
0
Market Access & Policy *
Global Market Access
56
Launch Sequencing
1
Payer Evidence Generation
2
Payer Relationship Management
16
Pricing Strategy
2
Reimbursement Consulting
39
Government Policy
1
Advocacy Management
1
Legislative Monitoring
1
Medical Affairs *
Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
1
Evidence Generation
102
Clinical Trial Concepts
15
Health Economics Modeling
60
Internal Medical Education
21
Patient Journey Mapping
3
Research Gap Analysis
5
Scientific Communications Development
10
Market Access Advisory Panels
3
Payer Advisory Board Strategy
9
Strategic Communications Planning
32
Competitive Publications Analysis
5
Publication Planning
4
Scientific Platform Planning
24
Strategic Stakeholder Engagement
70
Advisory Board Strategy
43
KOL Relationship Management
10
Stakeholder Influence Mapping
29
Pharmacovigilance *
Risk Management
19
Risk Evaluation & Minimization
16
Risk Management Evaluation
4
Safety Communications
3
Safety Systems
83
Safety Data Analytics
35
Safety Data Intake & Triage
33
Safety Signal Evaluation
23
Quality & Mfg *
Facilities & Equipment
13
Calibration & PM Programs
1
Deviation Investigations
0
Equipment Maintenance
0
Facility Maintenance Programs
8
Facility Security Management
4
Production & Supply Chain
53
Clinical & Commercial Production
28
Labeling & Packaging
17
Storage & Distribution
21
Quality Management
80
Corrective Action Verification
51
Deviation Investigation
8
Quality Process Governance
23
Testing & Release
16
Batch Release Testing
2
Raw Material Testing
12
Stability Program Testing
3
Regulatory *
Compliance
152
Agency Meeting Support
45
Dossier & Application Development
20
eCTD Publishing & Validation
10
Pre-Submission Advisory Meetings
1
Regulatory Compliance
88
Labeling & Promotions
2
Core Data Sheet Management
1
Labeling Strategy Development
1
Maintenance & Renewals
9
Post-Approval Safety Reporting
4
Promotional Material Compliance
4
Variations & Supplements
3
Transparency & Disclosure
4
Clinical Disclosure
2
Clinical Transparency
3
Technology & Operations *
Automation & Efficiency
10
Clinical Data Automation
6
Lab Automation Systems
1
Supply Chain Automation
3
Data & Analytics
96
Advanced Analytics
46
Artificial Intelligence
7
Data Curation
11
Data Visualization
44
Digital Health Solutions
85
5G Infrastructure
3
Blockchain Applications
1
mHealth Applications
10
Patient Portals
25
Telemedicine Platforms
24
Show More (1)
Wearables & Sensors
29
Show Less (1)
Early Development
9
Clinical Supply Chain Automation
3
Clinical Trial Management Systems
7
Informatics Infrastructure
75
Cloud Computing Systems
50
Data Security Solutions
18
Data Storage Platforms
8
Operations
64
Communications
4
Communications & Corporate Affairs
1
Content Creation & Development
7
Human Resources & Talent Acquisition
26
Management Consulting
2
Show More (7)
Marketing
25
Medical Information Services
1
Medical Writing
1
Operations Management
0
Other
3
Product/Service
0
Public Relations
1
Show Less (7)
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This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. Our FDA subject matter experts will also address the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity.
Register here ➡️ Clinical Pharmacology Considerations for Novel Therapeutic Modalities - 12/04/2024 | FDA
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