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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
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