Curated Resources

TECHNICAL

Explore additional resources to support your learning and capability development.

Clinical Operations

Clinical Trials and Clinical Research: A Comprehensive Review

Patient Centricity in Clinical Trials

Regulations: Good Clinical Practice and Clinical Trials

Recalls, Corrections and Removals (Devices)

Drug Discovery & Development

The Drug Development Process

The Pathway from Idea to Regulatory Approval

Drug Design and Discovery: Principles and Applications

Drug Safety

Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

The Many Paths of Diversity in Clinical Trials

7 Things You Can Do to Avoid Drug Interactions

GMP

Current Good Manufacturing Practice (CGMP) Regulations

Wegovy Maker Novo Nordisk Rebuked by Watchdog Over Failure to Disclose Payments to UK Health Groups

Limitations of Current Digital Validation Tools

What are GxPs and How Do They Shape the Quality of Your Pharmaceutical Product?

GxP

Pragmatic GXP Compliance: Successfully Navigating the Often Complex and Maddening World of Regulatory Inspections, Inspection Readiness, and Knowing What’s Important

The Differences Between GCP, GLP and GMP Audits

Data Integrity and Compliance with GxP: A Pragmatic Approach

Healthcare Compliance

Determinants of Regulatory Compliance in Health and Social Care Services: A Systematic Review Protocol

Process Modeling and Conformance Checking in Healthcare: A COVID-19 Case Study

Semi-Automated Checking for Regulatory Compliance in e-Health

Healthcare Economics

Industry Influence in Healthcare Harms Patients: Myth or Maxim?

Key Considerations When Launching A Product in Today’s Healthcare Environment

Payment and Payer-Based Strategies

Disease Mongering and Drug Marketing

Market Access

A New Era for Market Access: Organizing the Function’s Broader Strategic Role

The Market Access of Innovation in Healthcare: Insights from EC-funded Research

Networked Devices Help Head Off Medical Woes and Speed Recovery

The Future of Integrated Evidence Planning in Biopharma

The Impact of Marketing Strategies in Healthcare Systems

Preparing for Commercialization

What Do You Need to Know about Health Economics and Outcomes Research (HEOR) in Pharma

Different types of HEOR Studies & their Objectives

Primer on Health Equity Research in Health Economics and Outcomes Research: An ISPOR Special Interest Group Report

Why Healthcare Market Segmentation is Invaluable to Providers

The US Healthcare Market Segmentation

Preparing for IND

What Are the Key Components of an IND Application?

Preparing an IND Application: 5 Best Practices from the Field

Overview of eCTD Submission Modules and Format

Phase 0 Clinical Trials

Phase 0 Clinical Trials: Conceptions and Misconceptions

An Overview of the Optimal Planning, Design, and Conduct of Phase I Studies of New Therapeutics

Phase 0/Microdosing Approaches: Time for Mainstream Application in Drug Development?

5 differences between Phase 0 and Phase 1 in Drug Development

Preparing for Phase 2

Understanding the Clinical Trial Phases

The Road to Approval: Navigating the Clinical Drug Development Process

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

An Overview of Phase 2 Clinical Trial Designs

Product Lifecycle Management

Mastering Product Lifecycle Management: A Comprehensive Guide

Product Managers Role at Each Stage of Product Life Cycle

The Inherent Difference and Connection Between CRM/PLM/SCM/MES and ERP

Product Lifecycle Management (PLM) Case Study: Process Optimization and Roadmap

Regulatory Affairs 101

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

Postmarketing Requirements and Commitments: Searchable Database

Special FDA designations for Drug Development: Orphan, Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy

Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries

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