The Essential Components of a Successful Pharmaceutical Development Team (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: May 25, 2011||End Date/Time: May 25, 2011|
A pharmaceutical development team consists of multiple scientific disciplines that must work together in harmony in order for the development process to function smoothly and in a timely manner. During development each discipline relies at any given time on one or more of the other disciplines in order to successfully perform their own functions. Having a thorough understanding of the intricacies of the development timeline is essential in order to avoid costly mistakes, and to minimize potential delays. In addition, CMC development activities also depend in part on functions outside of CMC, and these activities must also be managed by the pharmaceutical development team. Knowing what questions to ask and when, and knowing what data is needed from other disciplines, can be critical to preparing the CMC section of an IND.
Areas Covered in the Seminar:
- The pharmaceutical development timeline
- The purpose of the pharmaceutical development team
- The role of cGMPs in pharmaceutical development
- The scientific disciplines that comprise a CMC pharmaceutical development team
- Various activities and responsibilities for each of the scientific disciplines
- Interactions with disciplines outside of CMC
- Benefits of a knowledgeable pharmaceutical development team
- Problems arising from an inexperienced team
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