概览

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This program will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and potentially minimize the risks associated with shepherding a new drug candidate through the development process. At the end of the program, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs in the US and Europe, and to expand the life cycle of in-line products.

The online program includes six self-paced modules that can be accessed 24 hours a day, 7 days a week. Modules do not have to be taken in one sitting; users can start/stop at any time and begin where they left off. Users will have one year to complete the modules and continuing education credits are offered. These six modules will take approximately 6.5 hours to complete.

精选主题

An expensive and risky proposition
Regulations
Functional areas
Workstreams
Timeline
Objectives and key players
The IND and CTA
Phase 1 studies
Phase 1 decisions
Regulatory activities
Clinical R&D and biostatistics activities
End of phase 2
Phase 3 activities
Safety reporting requirements
Regulatory review
The Common Technical Document
Objectives of phase 4 and lifecycle management
The product lifecycle
Post-approval activities and decisions
Lifecycle management
Case studies
Reviews

谁应该参加？

These modules are designed for individuals who are new to, or changing roles, in the pharmaceutical and biotech industries. These modules will also benefit professionals who work in the area of:

学习目标

Module 1: Introduction to Drug Development: Upon completion of this module, learners should be able to:
- Describe the use of a Target Product Profile (TPP) as a tool in designing a drug development program
- Describe the phases of drug development
- Identify the sources of drug development regulations
- List the functional areas involved in the drug development process
- Describe the workflow for bringing a new drug to market
Module 2: Discovery and Pre-Clinical Phases: Upon completion of this module, learners should be able to:
- List discovery activities
- Recognize how toxicology studies are conducted
- Identify drug substance production and drug product formulation activities
- Determine the functions of good manufacturing and laboratory practices
- Recognize how biomarkers and surrogate endpoints are used
Module 3: Drug Development Phase 1: Upon completion of this module, learners should be able to:
- Outline the key objectives of phase 1 studies
- Describe the regulatory submissions required for phase 1 studies
- List key activities that need to be completed before first-in-human clinical trials can begin
- Examine risk-return decisions involved in phase 1 studies
Module 4: Drug Development Phase 2: Upon completion of this module, learners should be able to:
- Outline the key objectives and activities of phase 2
- Describe the regulatory activities and decisions that occur during phase 2
- Examine risk-return decisions involved in phase 2
Module 5: Drug Development Phase 3 and Regulatory Review: Upon completion of this module, learners should be able to:
- Outline the clinical study activities of phase 3
- Explain safety reporting requirements
- Discuss the regulatory review process in the US and Europe
- Detail the components of the CTD
Module 6: Drug Development Phase 4 and Lifecycle Management: Upon completion of this module, learners should be able to:
- List the objectives of Phase 4 studies and lifecycle management
- Describe the stages of the product lifecycle
- Outline post-approval activities and decisions that can grow or maintain market share by capitalizing on product or patient characteristics

注册

Drug Development and Lifecycle Management eLearning Program

概览

精选主题

谁应该参加？

学习目标

获得信息并保持参与