In-house Educational Training Programs

IND/CTA/NDA and FDA Regulatory Issues

1. Separating the Must-Have's from the Nice-to-Have's in IND CMC Sections
This session interprets the minimum FDA expectations for CMC sections of INDs to support phase 1 clinical studies and phase 2-3 studies as covered in their guidelines.  The session also explains the prudent CMC scientific studies that should be conducted in early development and how they should be summarized for a chemistry reviewer.  The session has recently been modified to include the depth of detail required for either a US IND or the EU CTA IMPD (Investigational Medicinal Product Dossier), and what information is required for both as well as in only one or the other submission. 

2. Regulatory Expectations for CTM
The FDA expects firms to comply with numerous regulations and guidelines as you progress through development.  Included here is a discussion of the IND requirements, the manufacturing GMP requirements and the GCP requirements.  Examples of data, procedures and practices (good and bad) will be used to illustrate these expectations. 

3. FDA Initiatives and their Impact on CMC Drug Development
This session will cover the FDA Initiatives for the 21st Century, illustrating the concepts of "design space", "pharmaceutical development" "quality by design", ICH Q8, Q9 and Q10. This is an overview session; for detailed topics, see the New for 2006 section below.

4. Meetings with FDA - CMC Issues
During the drug development lifecycle, companies have several opportunities to discuss their plans with the FDA; the pre-IND, EOP2 [end of phase 2] and pre-NDA meeting.  Here's what each meeting needs to cover.

5. The May 2004 EU Clinical Trial Directive - IMPD Issues Impacting US 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. The Common Technical Document - A Road Map of Detail to be Included in the QOS and Quality Module 3, Drug Substance and Drug Product
The CTD is about both format and content.  This presentation discusses the preparation of this regulatory submission with emphasis on the differences between the US NDA and the EU marketing approval. Examples of some of the less familiar sections (e.g., batch history, pharmaceutical development history) will be provided.

7. Preparing for PAI (Pre Approval Inspections)
The FDA PAI began in 1990 as a result of the generic drug scandal.  It's impact on CMC development in the 21st century is discussed, along with hints on what the PAI will cover and how to prepare for one.  Particular emphasis will be on how you can ensure your CMC contractors are prepared for the PAI.

8. Preparing for a QP or a EU Regulatory Inspection during Clinical Studies
In the EU, the QP (Qualified Person) must take personal responsibility for the quality of investigational medicinal products.  This involves a documentation review of the CMC drug product database and most often an audit of any US CTM manufacturer.