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自定义现场

• Adaptive Design in Clinical Trials: When and How to Apply

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• Advanced GCP Study Monitoring

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• Advanced Signal Management - Detection, Evaluation, and Decision-Making

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• Art of Writing a Clinical Overview

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• Benefit-Risk Assessment and Management Across the Lifecycle

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• Change Management, Issues Management, and Escalation Management

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• Clinical Project Management

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• Clinical Statistics for Nonstatisticians

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• Developing Standard Operating Procedures

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• Development of a Clinical Study Report

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• Drug Safety and Pharmacovigilance Across the Product Lifecycle

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• Electronic Submissions: The Next Era of Electronic Submissions

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• Enterprise Resource Management

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• Essentials of Project Management

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• Essentials of Safety Medical Writing

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• EU Regulation of In-Vitro Diagnostics

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• European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

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• Fundamentals of Clinical Research Monitoring

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• Fundamentals of Project Management for the Nonproject Manager

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• Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets

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• Good Clinical Practices for the Clinical Research Professional

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• High Performance Biopharm Teams

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• How to Prepare for a Safety Inspection

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• Innovative Statistical Approaches for Clinical Trials

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• Introduction to Computer Systems Validation

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• Introduction to Portfolio Management and Performance Metrics

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• Introduction to Signal Detection and Data Mining

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• Medical Affairs Training

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• Medical Devices: Regulation and Lifecycle Management

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• Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)

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• Navigating Chemistry, Manufacturing and Controls through the Drug Development Process

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• New Drug Product Development and Lifecycle Management

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• Oversight of Clinical Monitoring: Trends and Strategies

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• Overview of Drug Development

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• Overview of Drug Development in Japan

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• Premarketing Clinical Safety and Pharmacovigilance

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• Preparing for a US FDA Advisory Committee Meeting

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• Project Risk Management

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• Proven Strategies for Creating an Effective Clinical Research Program

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• Regulatory Affairs for Biologics

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• Regulatory Affairs: The IND, NDA, and Post-Marketing

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• Safety Risk Communication for Medical Products

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• Safety Risk Management: A Focus on EU RMPs and US REMS

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• Signal Management in Pharmacovigilance

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• Strategies for Good Clinical Practice Audits

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• The Pharmacovigilance Quality Management System

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