The pharmaceutical (and/or medical device) Global Development Plan (GDP) is your company’s roadmap to successful product development. The GDP contains key components of all the disciplines that will impact your project: early stage development, pre-clinical research, clinical trials, regulatory, manufacturing, CMC, quality, and IP to name a few. Generally, one person is charged with developing this plan; however, all disciplines feed into this important document. Therefore, collaboration among the different groups within your company is essential to produce a high quality plan. Companies with good, organized communication during this process set themselves up for success. Those that don’t are much more likely to fail.
This webinar will look at the different components of a development plan and review the information needed to capture the essence of your project. Additionally, this course will enable you to have an appreciation and understanding of the processes and the various facets associated with planning for successful drug development.
This interactive, 90-minute webinar will cover the following salient areas of a Development Plan:
- Summary of Development Strategy
- Product Profile
- Marketing Overview
- Non-Clinical Overview
- Clinical Development Strategy
- Regulatory and Risk Management Strategy
- Intellectual Property
- Manufacturing Strategy
- Back-up, Follow-up and In-licensing of compounds