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

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