Decisions in Drug Development: Portfolio Management Workshop is a highly interactive, hands-on learning experience! This 4-hour workshop provides an overview of the processes and challenges common to all new development products, basic drug development steps and ideal characteristics of a development candidate.

Basic Drug Development: Overview of Biopharmaceutical R&D presents the processes and challenges common to all product development projects, including small and large molecule therapies. Interactive workshops follow the development of a drug from discovery to product label development. Available as 1- or 2-day course.

Drug Development Decisions: NDA Simulation provides an understanding of the drug development and regulatory processes by simulating a “company project team” working together to get their “drug” approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which provide the groundwork for the IND and NDA game simulations.

Biologics Product Development presents an overview of the processes and problems common in biologics development. Participants understand decision points from initial identification to development processes through post-approval monitoring.

Medical Devices: Demystifying Regulation and Guidance provides an overview of safety considerations of medical devices. This course identifies critical definitions, classifications and device categories.

Pharmacology Concepts presents an intensive overview of pharmacology, including the principles of pharmacodynamics and pharmacokinetics. A general introduction to selected therapeutic areas is also included and can be tailored to your company’s area of specialty. Specific courses are also available on Pharmacokinetic Concepts and Applying Pharmacokinetic and Pharmacodynamics.

Project Management and Leadership Strategies for Pharmaceutical Scientists focuses on improving the leadership skills of project leaders and mid-level line managers who work in an environment that requires collaboration in order to be successful. The course uses an analytical model of leadership that is readily accepted by technically-oriented people.

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“After participating in this course, I have a greater sensitivity to regulatory requirements and a better understanding of PK/PD and trial design methodology.