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Early Post-Approval Planning

Post-approval is experiencing a new era of elevated public concern about drug safety, decreased R&D productivity, market demands for evidence-based data and increased regulatory rigor for post-approval services. It is more important than ever to integrate post-approval strategies with your clinical development plans. Activities traditionally focused on the post-approval period of the product life cycle are quickly shifting into Phase II-III, demanding a high degree of specialized knowledge for appropriate design and analysis. Starting with the end in mind can eliminate costly additional studies, provide valuable data at market introduction and aid in earlier detection of safety signals before they unfavorably affect your bottom line. A product's value and safety profile can be defined throughout the product life cycle:

Early Clinical Development - Phase II

  • Collect health outcomes measures
  • Identify product value drivers
  • Develop reimbursement strategy
  • Assess preclinical and clinical safety data

Phase III

  • Assess standard of care through preapproval disease registry
  • Collect health outcomes measures
  • Conduct risk analysis through automated signal detection
  • Collect additional safety data with pre-launch safety studies
  • Develop risk management plans
  • Begin formulary access through Academy of Managed Care Pharmacy (AMCP) dossier preparation

Approval/Product Launch

  • Gather real-world effectiveness data with observational studies
  • Promote physician adoption with online product launch activities
  • Develop publication strategy
  • Educate health care providers and patients with targeted communications

Post-Approval

  • Fulfill regulatory commitments
  • Promote adherence to treatment regimens with patient adherence programs
  • Develop new indications, delivery mechanisms and patent extensions with late-stage trials
  • Explore off-label usage with investigator-initiated trials
  • Assess long-term safety and determine optimal use with observational studies
  • Provide customer support and adverse event collection through medical information call centers
  • Conduct ongoing safety assessments and regulatory reporting through pharmacovigilance
  • Perform ongoing risk assessment and program evaluation for RiskMAP
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