Haas-and-Partners-Consultation-ServicesCONSULTATION SERVICES

OUR FOCUS IS SOLVING AND PREVENTING PROBLEMS THAT ADVERSELY AFFECT PRODUCT BENEFIT AND RISK.

We help clients to respond appropriately to safety issues through analysis of the available information and in the development of risk assessment and risk mitigation strategies. We seek practical approaches that are commensurate with the risks and with available resources. We support submission strategies and ensure that documents are appropriate in form, content and presentation. We provide direction on ensuring that there are systems in place that support compliance with regulatory expectations regarding management of issues relating to benefit and risk of products in development and on the market.

Strategy

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
Evaluation of clinical safety concerns  for early development decisions

Solutions

Pharmacoepidemiological data resources and study design
Development and Core Risk Management Plans
Assessment of nature and frequency of background risks for EU-RMP
Selection of appropriate tools for risk assessment- questionnaires, case report forms (CRFs), presentation of findings
Strategic life cycle management processes: early development through post approval
Training and supervision of safety physicians and other professional staff

Submissions and documents – benefit risk

Expedited reports- analysis of prior experience and evaluation of possible unanticipated problems
Periodic reports- Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Clinical Study Report (CSR)
EU-RMP preparation and submission
REMs documentation and submissions
FDA Integrated safety summary (ISS)- strategic guidance, analysis, assessment
Common Technical Document (CTD)- Clinical Overview and Clinical Summary

Systems

Pharmacovigilance gap analysis and remediation
Implementation of a signal detection and management systems
Process and training updates to accommodate regulatory changes