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
CTM Issues
1. The Investigational Supply Process
An overview of the entire drug development process with focus on the role of CMC groups and clinical supplies to support the clinical development program
2. Managing Differences Between Commercial and Clinical Products
During the evolution of a drug product, most every CMC aspect will require scientific investigation and development. While commercial (approved) products have standardized manufacturing and testing procedures, where specifications and packaging are fixed, investigational products will continually change. These changes reflect the ever-increasing body of knowledge and the ever-changing clinical development program. Here's what the differences are (and why different approaches to GMP are required).
3. Manufacturing, Packaging and Labeling of Investigational Medicinal Products
This is an introduction to the inter-relationship among numerous CMC disciplines and some of the issues that must be considered when embarking on a CMC program designed to produce investigational drug products.
4. Blinding of Positive Control Drugs (Comparators): Selection Criteria and Trade-offs
In 2000, the Declaration of Helsinki indicated concern about the ethics of placebo-controlled trials. Suggestions included conducting studies of investigational drugs against "best available therapy". This suggestion has been embraced by EMEA and more recently by FDA. The impact on preparing comparator (positive control drugs) products blinded to the investigational product will be discussed from a logistical, regulatory, and scientific perspective.
5. Incorporating Concepts of the EU Annex 13 for US Based Companies
In May 2004, the 25 member countries of the expanded EU placed into law the 2001/20/EC Clinical Trial Directive. The impact of these new and revised regulations (IMPD, CTA, EUDRACT database, EU Annex 13) will be described.
6. Defining the Clinical Supply Project - the MPL (Manufacturing, Packaging and Labeling Protocol)
The MPL is a definition document describing the manufacturing, packaging (primary and secondary), labeling, testing and distribution approaches and procedures are to be followed for a particular clinical supply project. The MPL is one form of a document used by the CMC group that parallels the clinical research protocol. Here's what to define and document.
7. Compliant Packaging and Maximizing and Measuring Patient Compliance in Clinical Trials
(see descriptions under Clinical Research - Clinical Supply Interactions)
8. Import and Export of Investigational Drugs
The rules for export of investigational drugs from the US into the EU are explained as well as the reverse (from the EU into the US).
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