The Drug Development Process - From R&D to Commercialization
Overview:
In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and knowledge to the levels required for an approvable launch.
An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations.
Why you should attend: How familiar are you with the complex and cross-functional activities that make up the drug development path? If you are involved in any step of drug development from discovery research through process development, pre-clinical and toxicological testing, GMP manufacturing, clinical trials and regulatory affairs, an understanding of how your role fits in with the other activities is key to achieving effective and efficient development and commercialization.
Areas Covered In the Seminar:
- The transition from discovery to development
- The purpose of Pre-clinical studies
- The four major clinical phases (1-4) in the drug development process and the rationale for each with key deliverables
- Milestones on The "Dual Path" to Drug Commercialization
- Where do IND and NDA fit into the process
- Overview of the key government regulations that impact the development process (Code of Federal Regulations and ICH)
- Designing the drug with the patient and regulations in mind
- The criticality of effective project management for cross-functional teams during the development process with special focus on managing activities performed by contract manufactures, labs and suppliers
Who will benefit:
- Research & development scientists
- Clinical monitors and research associates
- Medical and clinical investigators and study coordinators
- Statisticians & data management professionals
- CMC/pharmaceutical research professionals
- Regulatory Affairs Professionals
- Project Managers
- Senior sales managers
- Analytical Development
- Program Management