The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations
Why Should You Attend:
In the recent past, there have been several high-profile patient injuries and deaths in phase 1 human clinical trials. Investigational drugs and biologics must be manufactured per current good manufacturing practices (CGMPs). Although it is understood that as product development proceeds from early to late stage clinical trials, the stringency with which CGMPs must be followed increases, sterile drugs must be proven sterile before clinical trials may begin, and for biologic products, the aseptic processing and necessary viral clearances, etc. must also be proven before introducing the product into people.Areas Covered in the seminar:
Regulatory requirements to manufacture investigational drugs and biologics for the U.S. and European Union:- Highlights of recent FDA guidance documents
- Recommendations in earlier FDA guidance documents
- Practical issues
- Where you can get more information; recommended resources and clinical trial material groups
Who Will Benefit:
This session will benefit industry professionals, managers, and scientists working in:- Quality assurance/quality control
- Research and development
- Manufacturing
- Process development
- Regulatory affairs
- Clinical operations
Course Provider
Barbara Immel,
