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RISK MANAGEMENT RISK MANAGEMENT PUBLIC WORKSHOPSPUBLIC WORKSHOPS

APRIL 9-11, 2003APRIL 9-11, 2003

NTSB BOARD AND CONFERENCE NTSB BOARD AND CONFERENCE CENTERCENTER

WASHINGTON, DCWASHINGTON, DC

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RISK MANAGEMENT CDER/CBER EXECUTIVE RISK MANAGEMENT CDER/CBER EXECUTIVE OVERSIGHT COMMITTEEOVERSIGHT COMMITTEE

Steven Galson, ChairSteven Galson, Chair Paul Seligman, Vice- Paul Seligman, Vice-ChairChair

Jesse Goodman, CBER LeadJesse Goodman, CBER Lead Helen Winkle Helen Winkle

Jane AxelradJane Axelrad John Jenkins John Jenkins

Susan AllenSusan Allen Sandra Kweder Sandra Kweder

Deborah HendersonDeborah Henderson Susan Ellenberg Susan Ellenberg

Rachel BehrmanRachel Behrman Victor Raczkowski Victor Raczkowski

Lee Lemley, Project ManagerLee Lemley, Project Manager

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Risk Management Working Risk Management Working GroupsGroups

• Group I - Risk AssessmentGroup I - Risk Assessment– Premarketing Risk AssessmentPremarketing Risk Assessment

• Group II - Risk ManagementGroup II - Risk Management– Risk Management ProgramsRisk Management Programs

• Group III - PharmacovigilanceGroup III - Pharmacovigilance– Risk Assessment of Observational Data: Good Risk Assessment of Observational Data: Good

Pharmacoviligance Practices and Pharmacoviligance Practices and Pharmacoepidemiologic AssessmentPharmacoepidemiologic Assessment

Moderator - Dr. Paul Seligman, DiModerator - Dr. Paul Seligman, Director, OPaSSrector, OPaSS

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Risk Management ProgramsRisk Management ProgramsApril 10, 2003April 10, 2003

AGENDAAGENDA

• 8:00 - 8:158:00 - 8:15 Welcome and IntroductionsWelcome and Introductions

• 8:15- 10:008:15- 10:00 Session I Session I

• Concepts of Risk Management, when is an RMP appropriate?Concepts of Risk Management, when is an RMP appropriate?

• Risk Management ToolsRisk Management Tools– FDA Overview/PresentationsFDA Overview/Presentations

Clarification QuestionsClarification Questions– Oral PresentationsOral Presentations

• 10:00-10:15 Break10:00-10:15 Break

• 10:15-12:00 Session I (cont’d)10:15-12:00 Session I (cont’d)– Oral Presentations (cont’d)Oral Presentations (cont’d)– Discussion and Questions for SpeakersDiscussion and Questions for Speakers

Moderator - Dr. Paul Seligman, DiModerator - Dr. Paul Seligman, Director, OPaSSrector, OPaSS

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Risk Management ProgramsRisk Management ProgramsApril 10, 2003April 10, 2003

AGENDAAGENDA

• 12:00- 1:0012:00- 1:00 Lunch Lunch

• 1:00- 1:451:00- 1:45 Session II - Session II -

• Evaluation of Risk Management Programs andEvaluation of Risk Management Programs and

• Elements of a Risk Management SubmissionElements of a Risk Management Submission– FDA Presentations/Clarification QuestionsFDA Presentations/Clarification Questions

• 1:45- 2:001:45- 2:00 BREAKBREAK

• 2:00 - 4:002:00 - 4:00 Session II (cont’d)Session II (cont’d)– Oral PresentationsOral Presentations

– Discussion and Questions for SpeakersDiscussion and Questions for Speakers

• 4:00 - 4:304:00 - 4:30 Wrap-up, Moderator, Workgroup Chair and Wrap-up, Moderator, Workgroup Chair and Co-LeadersCo-Leaders

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LogisticsLogistics

• Questions for speakersQuestions for speakers– Cards being distributedCards being distributed– Open microphones for clarifications on concept Open microphones for clarifications on concept

paperspapers

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LogisticsLogistics

• TranscriptsTranscripts [Docket 02N-0528][Docket 02N-0528] - - Available within 30 days after the Available within 30 days after the workshopworkshop - Internet - Internet AddressAddress http://www.fda.gov/ohrms/docketshttp://www.fda.gov/ohrms/dockets

• Workshop Website Address Workshop Website Address http://www.fda.gov/cder/meeting/riskmanagement.htmhttp://www.fda.gov/cder/meeting/riskmanagement.htm

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LogisticsLogistics

• No food or drinks are allowed in the No food or drinks are allowed in the conference roomconference room

• Restrooms are located in the registration Restrooms are located in the registration lobby arealobby area

• Note exits from the roomNote exits from the room