Course Title:	Decision Points in Drug Development
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Course Description: Day 1: - This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch. These decisions include identifying a lead, choosing a compound for development, conducting pre-clinical work to assess which drugs should go to clinic, determining that drugs are safe in the clinic, establishing the dose, generating a label, and deciding to file an NDA. A key element of the module is a discussion of how the product label drives the drug development process. The difference between an activity based and a knowledge based drug development process is also addressed. You should expect to spend approximately 5 hours of study time to complete the course. You will have a two-month access after you register for the course.
Course Title:	Pharmacology Online: The Fundamental Principles
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Course Description: Day 1: - Day 2: - This course will provide an intensive overview of the general principles of pharmacology, the relationship between pharmacokinetics and pharmacodynamics, the effects of drugs on the autonomic nervous system, and will discuss pharmacology as it applies to the major organ systems, the central nervous system, and the cardiovascular system. It is designed to identify the traits of drug discovery and drug development including clinical trials.
Course Title:	Statistical Concepts Used in Clinical Trials
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Course Description: Day 1: - This course reviews statistical terminology, provides an understanding of statistics, and explains trial design from a clinician¿s viewpoint. The course illustrates how statistical tests are chosen and interpreted. It will allow one to think like a statistician, but is not designed to teach students to be a statistician. It emphasizes the importance of an ongoing collaboration to create synergy, enhance creativity, and improve trial design execution and analysis. Knowledge of statistics is not a prerequisite; however, the course assumes previous rudimentary exposure to statistics through work or the classroom.
Course Title:	Clinical Monitoring & Site Management
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Course Description: Day 1: - This course will describe site management and clinical monitoring responsibilities, review regulations for monitoring clinical research activities, explain current issues of the informed consent process, review the importance of trial data, and outline reporting regulations and monitoring for adverse events. It will provide a comprehensive overview of FDA and Health Protection Branch (HPB) regulations, as well as International Conference of Harmonization (ICH) guidelines.
Course Title:	Applied Good Clinical Practices
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Course Description: Day 1: - This course will describe the history of GCPs, as well as define appropriate documentation and requirements for clinical trials, internal auditing systems, roles for the sponsor, monitor, investigator, and regulatory authorities, and appropriately use GCP principles for the reporting of adverse events. In addition, this course will guide the learner through international GCP regulations, how a Clinical Quality Assurance (CQA) Group interacts, and describe FDA Inspections.
Course Title:	GCP for the Clinical Research Team
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Course Description: Day 1: - This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the sponsor¿s responsibilities and the FDA¿s inspection process. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.
If you have questions or comments, or need additional information or service please contact us at Distance Education Courses or (703) 276-0178. We will be happy to assist you.