Impact of Pre-Clinical to Clinical Risk Assessment

California State University Fullerton
Fullerton, Garden Grove, Irvine, California, United States

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' Detecting key safety signals during the clinical trial phase in product development is critical for pharmaceutical companies during pre-clinical programs. This class will examine integrating risk management and clinical development plans to align with the overall program objectives of product safety. You will gain an understanding of the methodologies used in identifying drug safety risks and the clinical effects in product development. Class discussions will also explore pharmacovigilance planning, incorporating pre-clinical and clinical data into the risk assessment process and the potential impact on the clinical development process.
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Elements of this syllabus are subject to change.

Phone:714.278.2611

School Address:

California State University Fullerton College Park, Suite 100
2600 Nutwood Ave. (corner of Nutwood and Commonwealth)
Fullerton, CA 92834-6870 USA


Jobs & Resumes: Fullerton, Garden Grove, Irvine
Houses & Roommates: Fullerton, Garden Grove, Irvine
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Project Presentations
Forming a California Nonprofit Tax-Exempt Corporation
Human Resource Management for Nonprofit Organizations
Planning and Budgeting Process for Nonprofit Organizations
Legal and Financial Aspects of Fund Raising
Financial Management and Reporting
Grant Proposal Preparation
Pharmaceutical Risk Management
Risk Management Applications in the Product Development Lifecycle
Process Engineering in the Pharmaceutical Industry
Biotechnology and Bio-Processes
Facilities Design and Maintenance
Validation and Verification
Regulatory Affairs and Quality Assurance in the Pharmaceutical Industry
Navigating the Public Sector
Leadership in Public Administration
Embracing Change in Public Organizations
Strategic Thinking & Decision Making in the Public Sector

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