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Design new or update existing PV Systems

Setting up a fully compliant PV System is a complicated task, and brings together many different specialities and topics, and is governed by multiple regulations, directives and laws. PhV Services can help to simplify this task by utilising their considerable knowledge, experience and expertise and applying it to the client’s specific situation.

PhV Services specialise in the design of tailored PV Systems that balance in-house and outsourced activity within budget constraints, and which provide quality management and ensure compliance.

PhV Services can develop fully costed business models and assist in vendor selection or recruitment of in-house staff.

Typical services:

1) Baseline assessment

a. Map product distribution

b. Organisation (Affiliates / partners / distributors)

c. Existing staff and vendors

2) Regulatory Intelligence Compendium (RIC)

a. Identify local SME in each territory

b. Collect and translate local regulation

c. Identify local conventions (which may differ to local regulations)

d. Populate RIC and specify regulatory requirements for each product

3) Develop business plans for various strategies

a. Utilising in-house resource

b. Utilising external resource and vendors

c. Utilising contractual partners

4) Determine strategy

5) Vendor selection

6) Quality Management and ongoing regulatory intelligence and management of the RIC

 

Jonathan West has established multiple PV Systems for global applications. Please call +44 (0)1363 775981, email info@phvservices.com or click to discuss your requirements

Typical PV System topics include the following (non-exhaustive):

i. Set up

  • Appoint QPPV and Deputy
  • PSMF development and maintenance
  • RMP writing
  • SOP writing
  • SDEA writing
  • Eudravigilance registration and xEVMPD
  • Safety database
  • Establish Safety Committee to manage USR and communications with CA and patients and HCPs, including alerting them of changes to risk-benefit
  • Identify all regulations relevant to distribution geography
  • Create labelling overview
  • Disaster recovery planning and business continuity

ii. Maintenance

  • ICSR collection, processing and EV reporting
  • Literature screening
  • Signal detection/management and safety profile monitoring and benefit-risk evaluation
  • PSURs / PADERs / Clinical overviews
  • RMP effectiveness
  • Quality Management System
  • Calculate resource requirements and budgets
  • QC review output such as ICSRs, PSURs, signal detection reports
  • Manage quality and compliance KPIs
  • Input into staff training plans
  • Audit program
  • PV Auditing
  • PV Inspections preparation and support
  • Management of Core Safety Information
  • Input into the management of Safety Variations
  • Meeting commitments set by CA, and responding to CA requests
  • Reconciliation with and interaction between PV and Product Quality, Medical Information, Partners.