education and training programs to promote professional ... · 2 purpose of program to provide cder...
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Skill Building for Reviewers in CDER
14th ICDRA - Singapore2 December 2010
Workshop K14:00-15:30
Education and Training Programs to Promote Professional Competency
CDER/USFDA
CAPT Justina A. Molzon, M.S. Pharm., J.D.Associate Director for International Programs
Center for Drug Evaluation and Research/USFDA
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Purpose of Program
To provide CDER reviewers with the skills and knowledge needed to accomplish CDER’s missionFocus on improving science-based regulatory decision makingShould reflect spectrum of staff needs
New hiresExperienced reviewersTargeted topics based on urgent issues
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History of Training in CDER
Before 1988 -- On-the-job mentoring Various basic courses
Statistics, pharmacology, drug law Feb 1988: Institute of Medicine Workshop
Recommended establishment of FDA staff college, to provide comprehensive orientation, courses, and professional development of FDA Medical Reviewers
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TasksTasks
Competency-Based Reviewer Education
Developed by CDER staff based on critical work
TasksTasksTasks Tasks
TasksTasks
Knowledge
KnowledgeKnowledge
KnowledgeKnowledge
Skill
Skill
Skill
Skill
Competencies- CDER- Reviewer- Discipline
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Examples of Task and Knowledge
Task: Review and evaluate Investigational New Drug (IND) submission
Knowledge of:Types of submissionsDrug classesClinical trial design and protocolsDrug development processDrug reviewer requirementsFDA regulations, CDER guidancesDiscipline-specific data (pharmacology/toxicology, clinical pharmacology, chemistry, microbiology, biostatistics)
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Example of Task and Skills
Task: Review and evaluate Investigational New Drug (IND) submission
Skill in:Evaluation, comparative analysisCritical thinkingData organizationInterpersonal communicationConflict management
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Foundational ProgramsTopics include:
Drug development processFDA regulations Drug review processDiscipline-specific review requirementsScientific requirements outside their discipline (e.g., statistics for medical officers)Communication, focusing on technical writing and presentations
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Advanced Programs
Topics are selected to:Provide advanced and continuing education to CDER reviewersEnhance the science base of CDER reviewers
Expose reviewers to a diversity of opinionsIntroduce reviewers to new technologies
Strengthen science-based regulatory decision making
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Advanced Programs
Courses include:Pharmacokinetic Toxicokinetic Concepts and Applications in Drug Development and RegulationSurvival Data AnalysisUse of Nanotechnology in Drug DevelopmentAntisense and Oligonucleotide TherapeuticsGlycobiology
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Special Programs
CDER shares its expertise with others CDER Forum for International Drug Regulatory Authorities
CDER learns from othersWorkshops co-sponsored with interested associations and universitiesCDER Forum for International Drug Regulatory Authorities
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Skill Building for Reviewers in CDER
Thank you for your attention