VIGILANCE

Pharmacovigilance - Materiovigilance - Cosmetovigilance - Nutrivigilance
Medical Information Services - Vigilance Audits - Vigilance Training

VIGILANCE & MEDICAL INFORMATION
C

reative Pharma & HR Services provides integrated vigilance services at a global and local level (Greece & Cyprus) focusing on quality and adherence to regulations. Our success is based on the trust between client and vendor through our dedicated specialized personnel.

In full compliance with the National and European Legislation on medicinal products, medical devices cosmetics and food supplements, our Vigilance experts provide excellent consultation services while, giving you a great insight to your vigilance strategy planning.

PHARMACOVIGILANCE SERVICES

Creative PHS is committed to patient safety offering premium and cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety.

Creative PHS offers a fully compliant and high-quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximize product potential, whilst ensuring patient safety.

From outsourcing of individual activities to the setup and management of an effective and efficient global pharmacovigilance system, Creative PhS provides solutions specific to the requirements of our customer’s organization and products.

Post-marketing

  • PV Consultancy and Project Management
  • Establishment and maintenance of Pharmacovigilance System, including writing of related SOPs and Pharmacovigilance System Master File (PSMF)
  • Provision of EU QPPV/Deputy EU QPPV or Local QPPV/Representatives to Greece & Cyprus
  • 24 hours availability of EU/QPPV and Deputy EU/QPPV
  • ΜΑΗ registration to SME & Eudravigilance database
  • Scientific Global & Local Literature Surveillance
  • Management of AEs/ADRs and other relevant safety information from any source
  • Electronic submission of information on MAH medicinal products to XEVMPD
  • Preparation and submission of Aggregate Safety Reports
  • Preparation and submission of Risk Management Systems
  • DHPC Management
  • Storage and protection of Pharmacovigilance records
  • Monitoring of Product Safety/Signal Detection
  • Preparation for Pharmacovigilance Audits/Inspections
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Pharmacovigilance Training

Clinical/Pre-approval

  • PV Consultancy and Project Management
  • Provision of Responsible Person for pharmacovigilance (RP) for clinical trials
  • Eudravigilance registration
  • Assessment and medical review of serious adverse events
  • SUSAR reporting to Eudravigilance and Competent Authorities/Site Investigators
  • Ongoing risk/benefit assessment of the IMP
  • Compilation and update of the Clinical Safety Reports (DSUR)
  • Contribution to the Clinical Study Report

TIME IS A DRUG. TOO MUCH OF IT KILLS YOU.
– TERRY PRATCEHETT, SMALL GODS

MATERIOVIGILANCE SERVICES

Creative PHS provide a full range of medical device vigilance services in support of both device clinical investigations and post-marketing needs. Our team of vigilance experts are well experienced in the differing requirements for CE-marked and non-CE marked devices, Implantable Medical Devices, In Vitro Diagnostic Medical Devices and drug-device combination products following both EU MEDDEV guidance and local standards.

  • Materiovigilance Consultancy and Project Management
  • Set up and maintenance of complete MDV system, for all types of devices
  • Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
  • Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to Competent Authorities
  • Monthly compliance and status reporting
  • ADE and MDI Reconciliation
  • Preparation of Periodic Summary Reporting
  • Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
  • Writing and/or reviewing Standard Operating Procedures
  • Audits/inspections and training on Materiovigilance
  • Writing and/or reviewing of Materiovigilance Agreements
COSMETOVIGILANCE SERVICES

The EU Cosmetics Regulation requires that the Responsible Person continuously monitors and records (post-marketing surveillance) all health-related undesirable effects possibly due to the use of cosmetic products.

This is referred to as “COSMETOVIGILANCE”. The cosmetovigilance records must be regularly evaluated and they form the basis for eventual product safety re-assessment and/or if relevant even further steps (e.g. EU warning system, market withdrawal, product recalls, etc).

Creative PHS can set up an efficient system for undesirable health-related effects tracking, monitoring and evaluation. In addition, Creative PhS can also integrate it into your existing product re-call procedures.

  • Provision of Qualified Person for Cosmetovigilance
  • Comprehensive management of adverse effects of cosmetics reported by consumers, health professionals or authorities
  • Submission of serious adverse effects to the competent authorities.
  • Implementation of cosmetovigilance system
  • Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
  • Cosmetic Product Safety Report
  • Signal Detection and Management
  • Audits to cosmetovigilance system
NUTRIVIGILANCE SERVICES

Creative PHS provides expert nutrivigilance services to dietary supplements, nutritional and natural products, and food supplements companies.

Our experts develop and maintain a proactive scientific safety system for your products. We work on end to end nutrivigilance process, ranging from adverse event intake to risk management, compliance and quality assurance.

  • Provision of Qualified Person for Food Supplement Vigilance
  • Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
  • Submission of serious adverse reactions to the competent authorities.
  • Periodic literature search in scientific literature to identify safety information and adverse reactions of food supplement products
  • Implementation of Nutrivigilance System
  • Food supplement Product Safety Report
  • Signal Detection and Management
  • Audits to Nutrivigilance System
MEDICAL INFORMATION SERVICES

Our mission at Creative PHS is to provide the highest quality medical information service to healthcare professionals and patients by ensuring all enquiries receive accurate and medically sound responses, whilst meeting regulatory and legal requirements.

With a team of experienced, educated and dedicated personnel to patient safety and customer service, Creative PHS can offer a flexible, modular Medical Information service, tailored to your specific requirements.

We are your partner, working with you to ensure your customers have current and accurate information for your products.

  • Provision of Medical Information Specialist and back-up
  • 24h availability for the receipt of medical information enquiries via telephone or other media
  • Receipt & processing of medical information enquiries by health professionals, consumers or business partners
  • Intake and processing of Adverse Events and Product Quality Complaints
  • Reconciliation, quality and compliance reporting

THE WORD FOCUS MIGHT BE ONLY SMALL, BUT THE MEANING IS HUGE WHEN IT COMES TO SAFETY.

VIGILANCE AUDITS

Creative PHS provides expert services to meet the auditing environment demands of Pharma Companies ensuring adherence to standards and compliance to applicable legislation.

Creative PHS may perform vigilance audits of main functions, affiliates and contractual partners and prepare organizations before and after vigilance audits by contractual partners or regulatory inspections.

  • Provision of Certified Auditor
    •      (QMS) Auditor/Lead Auditor (ISO 9001:2015) Certified by CQI & IRCA
    •      Internal Auditor (ISO 9001:2008) Certified by CQI & IRCA
    •      Pharmacovigilance Auditor Certified by RQA
  • Conduction of Vigilance Internal or External Audits to Pharma Companies & External contractors
  • Pre-Audit/Inspection provision of preparedness training and assessment of the company readiness
  • During Audit/Inspection phase attendance and consultation
  • Post- Audit/Inspection phase CAPA plan preparation and monitoring of the achievement of compliance within the suggested timelines.
VIGILANCE TRAINING SERVICES

Creative PHS provides the first line of contact between the pharma organization and its customers, providing medical, scientific, and technical information in response to inquiries regarding any type of medical product.

Vigilance training can be exclusively adapted to your group’s and company’s needs strengthening the learning experience. Training can be delivered in Greek and English language.

  • Annual Vigilance Training to Pharma Organizations covering all types of products
  • Tailored made training of organisation personnel based on specific needs and requirements to ensure performance competency and improve sustainability practices and productivity
  • Training can take several forms, including, among others, short courses, long-term structured programs, group sessions and individual coaching.
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