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Evidence based, strategic benefit-risk management throughout the product life cycle. Evidence based analysis, decision making and action- Building on a careful appraisal of available evidence we provide guidance for characterizing, assessing and mitigating patient safety and benefit risk issues. Client-oriented, practical solutions from first in man to post-approval management of safety and effectiveness. Client focused, practical …

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Evidence based, strategic benefit-risk management throughout the product life cycle. Evidence based analysis, decision making and action- Building on a careful appraisal of available evidence we provide guidance for characterizing, assessing and mitigating patient safety and benefit risk issues. Client-oriented, practical solutions from first in man to post-approval management of safety and effectiveness. Client focused, practical …

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Home - Haas and Partners | haasandpartners.com Reviews

https://haasandpartners.com

Evidence based, strategic benefit-risk management throughout the product life cycle. Evidence based analysis, decision making and action- Building on a careful appraisal of available evidence we provide guidance for characterizing, assessing and mitigating patient safety and benefit risk issues. Client-oriented, practical solutions from first in man to post-approval management of safety and effectiveness. Client focused, practical …

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haasandpartners.com

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PRODUCT LIFE CYCLE - Haas and Partners

http://haasandpartners.com/project/product-life-cycle

Evidence Based, Strategic Benefit-Risk Management Consulting. New information relevant to a product benefit-risk relationship may be identified at any point in the product life cycle. The nature of the information and its implications differ accordingly. We help clients assess the potential impact of findings on product development and regulatory strategy and to determine what actions should be considered. Label and line extension s Leverage existing evidence to facilitate label and line extensions.

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About - Haas and Partners

http://haasandpartners.com/about-haas-and-partners

Evidence Based, Strategic Benefit-Risk Management Consulting. Boston based Haas and Partners Collaborates with a global network of experts in a broad range of disciplines. 8220;Client-oriented, practical solutions from first in man to post-approval safety and effectiveness.”. Joanna F Haas MD MSc, FACP, FACPM. FISPE. Haas and Partners LLC. CHIEF SCIENTIST, PHARMACOVIGILANCE OptumInsight. Waltham, MA, USA. VICE PRESIDENT, GLOBAL PATIENT SAFETY AND RISK MANAGEMENT. Cambridge, MA, USA. MCGILL UNIVERSITY Dip...

3

Consultation Services - Haas and Partners

http://haasandpartners.com/consultation-services

Evidence Based, Strategic Benefit-Risk Management Consulting. OUR FOCUS IS SOLVING AND PREVENTING PROBLEMS THAT ADVERSELY AFFECT PRODUCT BENEFIT AND RISK. Regulatory meeting preparation for safety issues- FDA, EU. Strategy, preparation and submission of EU Risk Management Plans (EU-RMP). FDA Risk Evaluation and Mitigation Strategies (US-REMS- strategy and execution. Management of identified or potential risks for products in development. Due diligence evaluation for in-licensing candidates. Common Techni...

4

PRODUCT RANGE - Haas and Partners

http://haasandpartners.com/project/product-range

Evidence Based, Strategic Benefit-Risk Management Consulting. In addition with work with small molecule pharmaceuticals,. Haas and Partners brings experience with biological products and advanced therapeutics. We focus on innovative therapies in development, are highly tuned to the impact of production particularly of therapeutic proteins, and familiar with risk assessment in association with manufacturing. Pharmaceuticals ADME, CYP 450, pharmacogenetics. GIVEN THE BROAD EXPERIENCE ACROSS THERAPEUTIC AND...

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THERAPEUTIC AREAS - Haas and Partners

http://haasandpartners.com/project/therapeutic-areas

Evidence Based, Strategic Benefit-Risk Management Consulting. Although our approach and methods are applicable across therapeutic areas, Haas and Partners builds on experience from a wide range of clinical settings. Including oncology, transplant, respiratory and cardiovascular disease, renal and metabolic disorders, neurological and infectious diseases. In each setting we take into account applicable regulatory guidance, disease specific benefit risk considerations and the size of the population. NEW IN...

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Home - Haas and Partners

Evidence Based, Strategic Benefit-Risk Management Consulting. Evidence based, strategic benefit-risk management throughout the product life cycle. Evidence based analysis, decision making and action-. Building on a careful appraisal of available evidence we provide guidance for characterizing, assessing and mitigating patient safety and benefit risk issues. Client-oriented, practical solutions from first in man to post-approval management of safety and effectiveness. Client focused, practical solutions-.

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