The Drug Development Process - From Discovery to Commercialization - Webinar By GlobalCompliancePanel

The Drug Development Process - From Discovery to Commercialization - Webinar By GlobalCompliancePanel

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.

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

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