| Starts: | Monday November 09, 2009 at 8:00am |
|---|---|
| Ends: | Wednesday November 11, 2009 at 1:00pm |
| Event Type: | Training/Seminar |
| Region: | Washington D.C. Metro Area |
| Location: |
Hyatt Arlington Hotel Arlington, VA US |
| Price: | $1870 |
| Website: | http://www.peri.org/course_details.cfm?course=1959 |
| Industry: | pharmaceuticals |
| Keywords: | Nonclinical, Drug Safety, Package Label, Regulatory Affairs, Marketing, Drug Development, Basics, Clinical, Fda |
| Intended For: | Those new to drug development: Those in domestic or international pharmaceutical companies who are new to pharmaceutical development or other interested individuals who desire a comprehensive overview of the pharmaceutical development process. This cours |
| Organization: | PERI |
This course will provide an overview of the process and issues common to all new molecular entity (NME) development projects. The course will focus on the decisions that need to be made throughout the pharmaceutical development process and the criteria influencing these decisions. The faculty for this Gold Standard course are selected as experts in their field. Each speaker presents information and insights on the area of pharmaceutical development in which he/she excels.
Key Topics: • Overview of Decision Points in Pharmaceutical Development • Drug Discovery • Selection of Development Candidates • Strategic Plans and Project Management • Active Pharmaceutical Ingredient • Pharmaceutical Dosage Form Development • Nonclinical Drug Safety Evaluation • Pharmacokinetics/Pharmacodynamics • Clinical Development and Operations • Regulatory Review Processes: IND & NDA • Workshop: Developing a Package Label • Safety Surveillance • International Regulatory Affairs: Global Development • Role of Marketing Input in Pharmaceutical Development • Exclusivity Through Intellectual Property • Panel Discussion with FDA Representatives: Putting It All Together