The Center for Professional Advancement, New Brunswick, NJ
August 9-10, 2007
This course is designed for those responsible for writing and implementing clinical research protocols for all phases of development in:New Drugs
Biologics
Devices
Approved Drugs In addition, this course is recommended for all clinical research personnel that advise on how clinical protocols are to be adhered and referred to in the process of conducting clinical research for global approvals. Participants should have a good understanding and knowledge of GCP.
Description:
Achieving a successful clinical program is based on collecting and evaluating precise safety and efficacy data that will form the basis of information for product approvals by global regulatory agencies. Clinical protocol development is key for product approvals that come under the jurisdiction of INDs, NDAs, BLAs, ANDAs, and CTDs. The clinical process necessary to write protocols that will meet new product development will be presented along with detailed discussions of protocol requirements for phases 1, 2, 3, 3b, and 4. Specific components in protocol content will be detailed especially for inclusion and exclusion criteria, valuations of safety and efficacy, and specific requirements for reporting AEs and ADRs via FDA regulations and EU Directives. Case Report Form (CRF) development and content will be presented. Discussions include regulatory components and sponsor and investigator obligations in implementing clinical protocols. The significance of investigator meetings, clinical site selections, pre-investigator site visits (PISVs) and international research programs, and a protocol workshop.
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