In-house Educational Training Programs

Strategic Planning for CMC Development
IND/CTA/NDA and FDA Regulatory Issues
Clinical Research - Clinical Supplies Interactions
Good Manufacturing Practices
CTM Issues
CMC Issues
New Topics for 2006

CMC Issues

1. Advanced CMC Basics
This presentation covers the API, analytical, preformulation and formulation development activities that are prudent to conduct in early development.  The coordination among these disciplines and their progress is key to other groups, e.g., toxicology studies and clinical manufacturing.  Here's how to avoid placing any of these CMC disciplines on the critical path.

2. CMC Development Plans
A development plan is a road map that defines the coordinated efforts of multiple CMC disciplines enabling each to appreciate the upstream and downstream activities and challenges their colleagues will face. This dynamic document can also be used to define a project facilitating effective proposals from contract organizations.

3. CMC for Biologics - Same or Different from Small Molecules?
There are several key differences between small molecule CMC development and the development of biologics.  This discussion includes dosage form approaches, analytical "tools" needed, specifications for early and late development and CMC regulatory differences.

4. Stability and Expiration Dating
Stability studies are conducted to ensure (for mature products) or to project (for early stage investigational products) an expiry date for a drug product.  The appropriate conduct of stability studies early in development is discussed and how the small amount of data can be interpreted to project expiration dates.  This topic also includes issues surrounding placing the expiration date (or use date or re-test date) on the labels of investigational products.

5. Coordinating and Managing Multiple CMC Contract Organizations
Many large firms and all smaller, emerging pharmaceutical and biotech companies use CMC contractors.  Discussed here are some of the critical issues in conducting due diligence assessments, GMP audits, directing versus monitoring contractor efforts and choosing wisely.  In the end, the best output is a function of the best direction and communication and examples of each will be provided.

6. Change Control for R&D
There are many regulations that touch on post-approval changes and how they are to be handled.  This session uses the concepts of these regulations and guidance documents to define and interpret a common sense change control approach for R&D and clinical supply operations.

7. Pharmaceutical Development Reports
In the Common Technical Document, Module 3, section P2 requests a development history.  This session describes the intent of this section and discusses how to create this summary document by using development reports throughout development.