SERVICES

Pharmacovigilance Services in USA

The USA follows a multi-faceted approach to the pharmacovigilance system. It is divided into two post-marketing systems namely, the FDA Adverse Event Report System (FAERS) for pharmaceuticals and biologic products and the Manufacturer and User Facility Device Experience (MAUDE) database for medical devices. It is voluntary for healthcare professionals, consumers, and patients to submit adverse drug reaction reports; however, it is mandatory for reporting by IND reporters, manufacturers, distributors, importers, and user facilities personnel. All adverse drug reaction reports can be submitted through the MedWatch website separately via voluntary and mandatory ADR reporting forms.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in USA that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management plan pharmacovigilance
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling documents – i.e Prescribing Information & Medical Guides (PIL)

Aggregate Reports

  • Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Authoring/Review of SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight<

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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