Drug Development and Clinical Science Course (Mar, 2017)

Drug Development and Clinical Science Course (Mar, 2017) is organized by Society of Clinical Research Associates (SOCRA) would be held during Mar 20 - 24, 2017 at Wyndham Philadelphia Historic District, Philadelphia, Pennsylvania, United States Of America.

This course has been established to develop an internationally accepted standard of knowledge and understanding of the research process and related regulations, as well as medical and scientific areas related to clinical research.

Learning Objectives : Upon completion of this (full) course the attendee should be able to :
- Discuss the Drug Development Process regarding the definitions, regulations, and processes from IND to NDA.
- Discuss the development and implementation of the International Conference on Harmonisation, the clinical research guidelines resulting from that collaboration, and how the ICH guidelines affect the clinical researcher.
- Discuss the (drug, device, biologics) development program, including protocol development, case report form design, project and program management, assessing costs and building budgets.
- Describe adverse drug reactions and adverse events, the drug development process, drug laws, statistical perspectives, specific mechanisms of drug actions, and IRB notifications.
- Discuss various perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.
- Discuss procedural and management issues regarding utilization and disposition of source documents
- Discuss regulations, generally accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.
- Discuss research ethics including the importance of the informed consent and the principles of medical research ethics as well as therapeutic misconceptions, randomizations, and placebos.
- Discuss cell biology including cell structure, function, and reproduction.
- Describe the development and science supporting genetics and pharmacogenetics.
- Discuss anatomy and physiology including selected body systems, organs, and how they function.
- Discuss the basic laboratory values in clinical research and their importance in the disease process.
- Discuss epidemiological and statistical issues related to the distribution and determinants of health related events in certain populations.