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Introduction to Pharmaceutical Development
Employees perform more effectively when they understand the context of their jobs and their contributions to the pharmaceutical or biotechnology development and/or marketing processes.
Our customized programs can teach you:
- The role of nonclinical development to the overall pharmaceutical and biotechnology product development processes
- The four phases of clinical development
- The role of manufacturing in the development process
- The role of FDA and other regulatory agencies
- Regulatory requirements for the clinical phases of development
- Regulatory submissions: INDs, NDAs, and other regulatory documents
- Meeting with FDA or other regulatory agencies
- The role of ICH in the development process in the US and abroad
- Other skills and topics as needed
We can also provide additional services such as:
- Pre-course “needs assessments” to identify the training and development needs of your organization or group
- Pre- or post-course consulting to address specific situations with your group or organization
- Follow-up interviews or assessments
- Summary reports of any assessments performed
Additional formats:
- We offer a number of different formats for customization of this topic, including abbreviated (e.g., half-day) and extended (e.g., two-day) formats, and shorter speeches and keynotes.
Please contact us to discuss how we could create a program to meet your needs.
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