35 Riskmap PPTs View free & download

Developing a RiskMAP PowerPoint PPT Presentation

Developing a RiskMAP - promotional techniques to publicize risk management (e.g., ... alternative therapy available and reversibility of adverse events preventability of the adverse event, ...

promotional techniques to publicize risk management (e.g., ... alternative therapy available and reversibility of adverse events preventability of the adverse event, ...

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Developing%20a%20Risk%20Minimization%20Action%20Plan%20(RiskMAP):%20Developing%20Interventions PowerPoint PPT Presentation

Developing%20a%20Risk%20Minimization%20Action%20Plan%20(RiskMAP):%20Developing%20Interventions - Sales loss regulatory actions litigation public concern loss of confidence risk perception ... model, organize tools around overcoming barriers (based on model) ...

Sales loss regulatory actions litigation public concern loss of confidence risk perception ... model, organize tools around overcoming barriers (based on model) ...

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Developing a RiskMAP - promotional techniques to publicize risk management (e.g., ... alternative therapy available and reversibility of adverse events preventability of the adverse event, ...

promotional techniques to publicize risk management (e.g., ... alternative therapy available and reversibility of adverse events preventability of the adverse event, ...

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Review of Tysabri Risk Minimization Action Plan RiskMAP PowerPoint PPT Presentation

Review of Tysabri Risk Minimization Action Plan RiskMAP - re: Tysabri, PML (death/disability) risk, other safety concerns, instructions to ... and diseases that could induce an immunocompromised status clearly spelled out' ...

re: Tysabri, PML (death/disability) risk, other safety concerns, instructions to ... and diseases that could induce an immunocompromised status clearly spelled out' ...

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Tysabri - Tysabri (natalizumab) Risk Minimization Action Plan (RiskMAP) Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management ...

Tysabri (natalizumab) Risk Minimization Action Plan (RiskMAP) Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management ...

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Special Considerations for Unused Drugs Subject to Restricted Distribution Programs PowerPoint PPT Presentation

Special Considerations for Unused Drugs Subject to Restricted Distribution Programs - Drugs are subject to FDA-mandated restricted distribution programs created by ... 15 drugs are required by the FDA to have Risk Minimization Action Plans (RiskMAPs) ...

Drugs are subject to FDA-mandated restricted distribution programs created by ... 15 drugs are required by the FDA to have Risk Minimization Action Plans (RiskMAPs) ...

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FDA Guidance for Industry Development and Use of Risk Minimization Action Plans PowerPoint PPT Presentation

FDA Guidance for Industry Development and Use of Risk Minimization Action Plans - Decision-making and consistency questions addressed. Public advisory committees ... Apply to a small number of products. Have clear goals and objectives. Use ...

Decision-making and consistency questions addressed. Public advisory committees ... Apply to a small number of products. Have clear goals and objectives. Use ...

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Considerations for the Use of Risk Minimization Action Plans FDA Draft Guidance and Experience PowerPoint PPT Presentation

Considerations for the Use of Risk Minimization Action Plans FDA Draft Guidance and Experience - Patient Package Inserts (PPI) 22. Medication Guides. FDA approved patient labeling ... Patient Package Insert (PPI) ... Pkg insert: Boxed warning, 2nd line indication ...

Patient Package Inserts (PPI) 22. Medication Guides. FDA approved patient labeling ... Patient Package Insert (PPI) ... Pkg insert: Boxed warning, 2nd line indication ...

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Developing, Pilot Testing PowerPoint PPT Presentation

Developing, Pilot Testing - Target key groups most likely to be able to minimize risk ... Market research data. Competitive products. Physician prescribing behavior ...

Target key groups most likely to be able to minimize risk ... Market research data. Competitive products. Physician prescribing behavior ...

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Recent Withdrawals PowerPoint PPT Presentation

Recent Withdrawals - Title: Developing Consumer Marketing Claims within the Clinical Development Process Author: Lou Morris Created Date: 9/29/2000 3:30:09 PM Document presentation format

Title: Developing Consumer Marketing Claims within the Clinical Development Process Author: Lou Morris Created Date: 9/29/2000 3:30:09 PM Document presentation format

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Potential Risk Management Tools for Oral Tazarotene: Context, Considerations, and Experience PowerPoint PPT Presentation

Potential Risk Management Tools for Oral Tazarotene: Context, Considerations, and Experience - Describe risk management context of PDUFA3 Draft Guidances ... Trademarked as PACT Two versions. NDA submission. Briefing document. 23 ...

Describe risk management context of PDUFA3 Draft Guidances ... Trademarked as PACT Two versions. NDA submission. Briefing document. 23 ...

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Considerations for the Use of Risk Minimization Action Plans FDA Draft Guidance and Experience - Goal End result, expressed in terms of one or more health outcomes to be achieved (or avoided) ... products with Medication guides, CME. Reminder systems ...

Goal End result, expressed in terms of one or more health outcomes to be achieved (or avoided) ... products with Medication guides, CME. Reminder systems ...

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Overview of FDA PowerPoint PPT Presentation

Overview of FDA - Overview of FDA s 2005 Risk Management Guidance Mark S. Brown King & Spalding LLP 1700 Pennsylvania Ave., N.W. Washington, D.C. 20006 (202) 737-0500

Overview of FDA s 2005 Risk Management Guidance Mark S. Brown King & Spalding LLP 1700 Pennsylvania Ave., N.W. Washington, D.C. 20006 (202) 737-0500

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Risk%20Management%20Strategy%20for%20the%20Pharma%20and%20Biotech%20Product%20Lifecycle:%20New%20Regulatory%20and%20Legal%20Focus%20and%20Approach - Risk Management Strategy for the Pharma and Biotech Product Lifecycle: ... New FDA Guidance documents on risk management programs ...

Risk Management Strategy for the Pharma and Biotech Product Lifecycle: ... New FDA Guidance documents on risk management programs ...

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Mary Ellen Turner MD, MPH PowerPoint PPT Presentation

Mary Ellen Turner MD, MPH - While approval times are decreasing, industry has experienced high profile drug ... that RM Plans may be a part of NDAs/BLAs submitted post October 1, 2002 ...

While approval times are decreasing, industry has experienced high profile drug ... that RM Plans may be a part of NDAs/BLAs submitted post October 1, 2002 ...

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Cardiovascular PowerPoint PPT Presentation

Cardiovascular - Class I - II NHYA congestive heart failure. AF of longer duration ... Decreases heart rate. Increases blood pressure. Converts AFib and AFl to NSR in dogs ...

Class I - II NHYA congestive heart failure. AF of longer duration ... Decreases heart rate. Increases blood pressure. Converts AFib and AFl to NSR in dogs ...

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Study Conclusion PowerPoint PPT Presentation

Study Conclusion - ... del 5q patients Conventional cytogenetic testing Significant clinical benefit Durable resolution of refractory anemia ... 00 60.00 76.00 73.00 113 ...

... del 5q patients Conventional cytogenetic testing Significant clinical benefit Durable resolution of refractory anemia ... 00 60.00 76.00 73.00 113 ...

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David Knipe - ... including 5 profiles, ... Company: 915 Designs Other titles: Arial Calibri Arial Black Office Theme Slide 1 FEMA floodplain designations Why Map Zone A s?

... including 5 profiles, ... Company: 915 Designs Other titles: Arial Calibri Arial Black Office Theme Slide 1 FEMA floodplain designations Why Map Zone A s?

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Risk analysis and postmarketing pharmacovigilance activities PowerPoint PPT Presentation

Risk analysis and postmarketing pharmacovigilance activities - Boehringer Ingelheim (Pty) Ltd. Acknowledgement & thanks: ... The Lancet starts collecting notifications of side effects after a death caused by anaesthesia ...

Boehringer Ingelheim (Pty) Ltd. Acknowledgement & thanks: ... The Lancet starts collecting notifications of side effects after a death caused by anaesthesia ...

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Tazarotene Capsules in the Treatment of Psoriasis FDA Advisory Committee Meeting July 12, 2004 PowerPoint PPT Presentation

Tazarotene Capsules in the Treatment of Psoriasis FDA Advisory Committee Meeting July 12, 2004 - Tazarotene Capsules in the Treatment of Psoriasis FDA Advisory Committee Meeting July 12, 2004 Patricia S. Walker MD, PhD Vice President, Skin Care Pharmaceuticals

Tazarotene Capsules in the Treatment of Psoriasis FDA Advisory Committee Meeting July 12, 2004 Patricia S. Walker MD, PhD Vice President, Skin Care Pharmaceuticals

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The%20International%20Pharmaceutical%20Compliance%20Summit%20on%20Medical%20Affairs,%20Clinical%20Trials,%20Safety%20and%20Publication - The International Pharmaceutical Compliance Summit on. Medical ... duty of care breached through nonfeasance: failure to investigate items from internal audit ...

The International Pharmaceutical Compliance Summit on. Medical ... duty of care breached through nonfeasance: failure to investigate items from internal audit ...

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Brian L. Strom, M.D., M.P.H. PowerPoint PPT Presentation

Brian L. Strom, M.D., M.P.H. - ... PharMark Corp, A.H. Robins Company, Rockefeller Foundation, ... SmithKline Beecham Pharmaceuticals, Whitehall-Robins Healthcare, and Wyeth-Ayerst Research ...

... PharMark Corp, A.H. Robins Company, Rockefeller Foundation, ... SmithKline Beecham Pharmaceuticals, Whitehall-Robins Healthcare, and Wyeth-Ayerst Research ...

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Trasylol - Trasylol (aprotinin injection) Bayer Pharmaceuticals Corp. NDA 20-304 Opening Remarks _____ Dwaine Rieves, M.D. Deputy Director Division of Medical Imaging and ...

Trasylol (aprotinin injection) Bayer Pharmaceuticals Corp. NDA 20-304 Opening Remarks _____ Dwaine Rieves, M.D. Deputy Director Division of Medical Imaging and ...

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Assessing%20the%20Safety%20of%20Marketed%20Drugs%20Current%20Issues%20and%20Controversies PowerPoint PPT Presentation

Assessing%20the%20Safety%20of%20Marketed%20Drugs%20Current%20Issues%20and%20Controversies - Assessing the Safety of Marketed Drugs. Current Issues and Controversies ... Drug therapy for individuals still largely empiric. 17 ...

Assessing the Safety of Marketed Drugs. Current Issues and Controversies ... Drug therapy for individuals still largely empiric. 17 ...

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Risk Management Planning Industry Experience in Implementation PowerPoint PPT Presentation

Risk Management Planning Industry Experience in Implementation - 1. Risk Management Planning. Industry Experience in ... EU QPPV Executive, Eli Lilly. 2. Risk Management A Sense of D j Vu? 'I am convinced that .

1. Risk Management Planning. Industry Experience in ... EU QPPV Executive, Eli Lilly. 2. Risk Management A Sense of D j Vu? 'I am convinced that .

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Drug Safety: What Should Companies Do Now? PowerPoint PPT Presentation

Drug Safety: What Should Companies Do Now? - Trust in FDA and Industry has eroded must be regained. What Are Companies. Being Asked to Do? ... Need to regain trust really put patients first ...

Trust in FDA and Industry has eroded must be regained. What Are Companies. Being Asked to Do? ... Need to regain trust really put patients first ...

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Tysabri natalizumab Biogen Idec Inc. BLA 12510415 PowerPoint PPT Presentation

Tysabri natalizumab Biogen Idec Inc. BLA 12510415 - Anti-natalizumab antibody formation assessed every 12 weeks in Phase 3 MS ... MS studies ... Persistently positive anti-natalizumab antibodies associated with infusion ...

Anti-natalizumab antibody formation assessed every 12 weeks in Phase 3 MS ... MS studies ... Persistently positive anti-natalizumab antibodies associated with infusion ...

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The Emerging Epidemic of Prescription Drug Abuse PowerPoint PPT Presentation

The Emerging Epidemic of Prescription Drug Abuse - marijuana, LSD, Club Drugs. Medicinal to Illicit Drugs ... Equal or greater abuse of OTC/Rx than cocaine, Ecstasy, LSD, ketamine, heroin, GHB, ice ...

marijuana, LSD, Club Drugs. Medicinal to Illicit Drugs ... Equal or greater abuse of OTC/Rx than cocaine, Ecstasy, LSD, ketamine, heroin, GHB, ice ...

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692009 5:57 PM PowerPoint PPT Presentation

692009 5:57 PM - Toe. 5 days tazarotene. 3915. Female. 30. Ankle. 80 days ... Toe. 0 days tazarotene. 1101. Gender. Age, y. Location. Duration Tx when fracture reported ...

Toe. 5 days tazarotene. 3915. Female. 30. Ankle. 80 days ... Toe. 0 days tazarotene. 1101. Gender. Age, y. Location. Duration Tx when fracture reported ...

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An Update on FDA PowerPoint PPT Presentation

An Update on FDA - ... for Drug Evaluation and ... planning process for drug development / phase 3 trials ... Conduct Research , Gain Consensus, and Develop Guidance to ...

... for Drug Evaluation and ... planning process for drug development / phase 3 trials ... Conduct Research , Gain Consensus, and Develop Guidance to ...

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The U.S. Approach to Risk Management PowerPoint PPT Presentation

The U.S. Approach to Risk Management - The most significant amendments to the Federal Food, Drug, and Cosmetic Act ... (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications ...

The most significant amendments to the Federal Food, Drug, and Cosmetic Act ... (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications ...

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Tetrabenazine Prestwick Pharmaceuticals, Inc. New Drug Application 21-894 PowerPoint PPT Presentation

Tetrabenazine Prestwick Pharmaceuticals, Inc. New Drug Application 21-894 - Peripheral and Central Nervous System Drugs Advisory Committee Meeting ... j Patient 213 received klonopin, restoril, aprazolam, lorazepam, beta blockers, ...

Peripheral and Central Nervous System Drugs Advisory Committee Meeting ... j Patient 213 received klonopin, restoril, aprazolam, lorazepam, beta blockers, ...

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AIDS TREATMENT ACTIVIST COALITION ATAC DRUG DEVELOPMENT COMMITTEE DDC PowerPoint PPT Presentation

AIDS TREATMENT ACTIVIST COALITION ATAC DRUG DEVELOPMENT COMMITTEE DDC - Congress reauthorized the Prescription Drug User Fee Act (PADUFA) for another ... appropriate, the Secretary shall promulgate regulations requiring such a statement. ...

Congress reauthorized the Prescription Drug User Fee Act (PADUFA) for another ... appropriate, the Secretary shall promulgate regulations requiring such a statement. ...

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An Evaluation of the Impact of REMS on spontaneous reporting for marketed products PowerPoint PPT Presentation

An Evaluation of the Impact of REMS on spontaneous reporting for marketed products - Data collection: Search the FDA AERS database using WebVDME (Lincoln Technologies, Inc. ... Rate (cases/yr) 236. 235. 1.00 (p 0.05) ...

Data collection: Search the FDA AERS database using WebVDME (Lincoln Technologies, Inc. ... Rate (cases/yr) 236. 235. 1.00 (p 0.05) ...

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Lagrangian Archive from MFS Eulerian Archive' PowerPoint PPT Presentation

Lagrangian Archive from MFS Eulerian Archive' - ... grouped the experimental drifters by seasons, as function of their release time. ... 82 52 78 98. 66 44 55 61. 97 62 89 107. 7. 58 62 55 58. 252 195 177 262 ...

... grouped the experimental drifters by seasons, as function of their release time. ... 82 52 78 98. 66 44 55 61. 97 62 89 107. 7. 58 62 55 58. 252 195 177 262 ...

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Riskmap PowerPoint PPT Presentations