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BoosConsulting supports you in the following areas:

                                                                   • Pharmacovigilance

                                                                   • Pharma Laws

                                                                   • Medical Devices

 

 Pharmacovigilance - advisory and supporting services for development compounds and established products

 

  • Compilation an maintenance of the Pharmacovigilance System Master File (PSMF)
  • Implementation of national/international legal PV requirements (e.g. ICH, Good Pharmacovigilance Practice / GVP)
  • Developing and establishing company-internal global PV standards, support in Brexit preparation
  • Setting-up / Optimizing PV systems in affiliates
  • Development and revision of SOPs/WIs and PV templates
  • Taking over interim PV / management positions
  • Strategic PV planning
  • Support in resource management and recruiting
  • Support in budget and cost centre planning / maintenance
  • European Qualified Person for Pharmacovigilance, EU QPPV (or Deputy)
  • German Graduated Plan Officer acc. to §63a German Drug Law (Stufenplanbeauftragter) (or Deputy)

 

  • Cumulative signal detection & evaluation
  • Benefit-risk assessment of medicinal products
  • Setting up Risk Management Plans (RMPs) and Risk Minimization Measures
  • Support in / Management of medical alert situation
  • Preparation and follow-up processing of Health Authority Inspections / Audits incl. CAPA development
  • Support in handling Health Authority deficiency letters, Referrals
  • Writing Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs)
  • Writing annual reports for clinical trials  - Development Safety Update Reports (DSURs)
  • Initial and continuous PV training of PV and non-PV staff (in-house, affiliates, CROs)
  • Medical/scientific presentations & training

  • Writing annual reports for clinical trials  - Development Safety Update Reports (DSURs)
  • Support for document in the context of
    • Interventional clinical trials (clinical trial protocols, safety reporting plans, case report forms, marketing authorization application documents, Investigator’s Brochures)
    • Non-interventional studies (NIS)
    • PASS/PAES (Post-Authorization Safety / Efficacy Studies)

  • Medical assessments of ICSRs from clinical trials and post-marketing experiences for development compounds & established products
  • Response preparation to product-specific medical-scientific requests sent by patients, pharmacists, physicians

 

  • Creation/maintenance of safety profile documents, e.g. CCDS, CCSI, SmPC
  • Expert Statements on requests from Health Authorities
  • Medical Writing (e.g. for Regulatory & Medical Affairs)
  • Preparations of complex medical/scientific subject matters (e.g. in the context of an Expert’s Report)
                      

 

 Pharma laws - advisory and supporting services for the implementation of legal requirements                              

 

  • Preparation/establishment of PV Agreements / Safety Data Exchange Agreements (SDEAs)
  • Contract design (Pharmacovigilance, Clinical Trials)
  • Other subject matters concerning the interface between pharmacovigilance and pharma law
  • Support of Mergers & Acquisitions
  • Distinction issues (medicinal product, medical device)
  • General Data Protection Regulation (GDPR), in particular in pharmacovigilance
                      

 

 Medical Devices - advisory and supporting services for market access and safety surveillance                               

 

  • Support in Medical Devices & Cosmetics Vigilance
  • Conformity Assessment Procedures
  • Clinical Evaluation Reports, Periodic Safety Update Reports (PSURs), Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
  • Distinction issues (medicinal products, medical devices, cosmetics)
                              

 

 

 

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