Regulatory and Pharmacovigilance Services

Regulatory Affairs

Drug product - Strategic and technical support

Proge Medica can support Marketing Authorisation Holders and Applicants in the fulfillment of regulatory obligations regarding the life cycle management of a marketing authorisation.

  • Regulatory updates by monitoring the websites of the Competent Authority (AIFA, EMA; CMDh, etc.)
  • Maintenance of contacts with the Competent Authority (AIFA, Italian Ministry of Health)
  • Strategic and technical support for obtaining a marketing authorization
  • Management of regulatory activities during the life cycle of the marketing authorisation (variations, reply to deficiency letters, renewals, monitoring of Sunset Clause warnings and request for Sunset Clause exemption, etc.)
  • Preparation of the registration Dossier, baselines and variations in electronic format eCTD, according to the European legislation
  • Preparation of readability test of the package leaflet, updating of the product information according to the QRD format
  • Due diligence and gap analysis of the registration Dossier
  • Preparation of consolidated Dossiers
  • Support in the use of the Italian Front-end platform (POL payments, variation and renewal submissions, etc.)
  • Company accreditation to AIFA (SIS code)
  • Role of simple attorney or special attorney at AIFA
  • Support in the notification to AIFA of the essential and non-essential modifications relating to manufacturing sites.
  • Support in the request for a Qualified Person authorisation

Drug product - Marketing technical support

Proge Medica can support Marketing Authorisation Holders and Applicants in the fulfillment of regulatory obligations regarding commercialization and marketing of the medicinal product.

  • Communications to AIFA and Databases of price change and shortage of medicinal products
  • Notification of concessionary sale contracts
  • Request for Free Sale Certificates
  • Support in the request of drug advertising authorisation
  • Support in the use of the Italian Front-end platform (annual transmission of the list of medical sales representatives, notification / modification of promotional material, authorisation of conventions-congresses, etc.)

For any inquiry regarding our services, please contact Proge Medica team.

Medical devices

Proge Medica can support Manufacturers in the fulfillment of regulatory obligations according to the new legislation issued by the European Community.

  • Support in the preparation and maintenance of the Technical File, in order to obtain or modify the CE certification
  • Registration of medical devices in the Database
  • Maintenance of contacts with the Competent Authority (Italian Ministry of Health)
  • Request for Free Sale Certificates
  • Support in the request for medical device advertising authorisation

For any inquiry regarding our services, please contact Proge Medica team.

Cosmetics

Proge Medica provides consulting services in order to comply with the Regulation (EC) n. 1223/2009.

  • Registration in the European CPNP portal
  • Verification of cosmetic products labeling compliance with Regulation (EC) n. 1223/2009
  • Support in the preparation of the Product Information File (PIF)

For any inquiry regarding our services, please contact Proge Medica team.

Food supplements

Proge Medica can help Companies with local requirements provided by the Italian Ministry of Health.

  • Verification of the food supplements labeling compliance with the regulations in force and revision of the claims used
  • First notification / labeling variations to the Ministry of Health using the new electronic notification system
  • Maintenance of contacts with the Competent Authority (Italian Ministry of Health)
  • Request for Free Sale Certificates

For any inquiry regarding our services, please contact Proge Medica team.

Pharmacovigilance

Pharmacovigilance System outsourcing

Proge Medica can support Marketing Authorisation Holders and Applicants in the fulfillment of all European pharmacovigilance obligations regarding the establishment and the maintenance of a Pharmacovigilance System through:

  • Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV) and a Deputy with 24/7 availability
  • Pharmacovigilance System set-up and development/maintenance of the Pharmacovigilance System Master File (PSMF)
  • EudraVigilance management, including ongoing medicinal product data reporting to XEVMPD
  • Case processing (ICSRs) and reporting
  • Regular global and local medical literature monitoring
  • Ongoing safety surveillance, signal detection, validation, evaluation and further communication, including EVDAS monitoring
  • Risk management, including development of Risk Management Plans (RMPs) and risk minimization measures handling
  • Development and submission of Periodic Safety Update Reports (PSURs)
  • Negotiation/update of Safety Data Exchange Agreements (SDEA)
  • Regulatory intelligence
  • Pharmacovigilance audits and inspections handling

For any inquiry regarding our services, please contact Proge Medica team.

Flexible Pharmacovigilance Solution

Proge Medica can provide Marketing Authorisation Holders and Applicants with a flexible pharmacovigilance solution tailored to their needs such as:

  • Case processing (ICSRs) and reporting
  • EudraVigilance ICSRs screening and selective import
  • EudraVigilance management, including ongoing medicinal product data reporting to XEVMPD
  • Regular global and local medical literature monitoring
  • Signal detection, validation, evaluation and further communication, including EVDAS monitoring
  • Development of Risk Management Plans (RMPs)
  • Development and submission of Periodic Safety Update Reports (PSURs)
  • Regulatory intelligence
  • Key Performance Indicators (KPIs) monitoring

For any inquiry regarding our services, please contact Proge Medica team.

Pharmacovigilance Database

Proge Medica pharmacovigilance and clinical safety management services are supported by the safety Database SafetyDrugs®, a fully E2B (R3) and CFR21 Part 11 compliant database, which has an integrated submission management tool for direct submissions, a selective import tool for Individual Case Safety Reports (ICSRs) triage and a business intelligence for signal detection.

It enables E2B-compliant HL7 file import and export, xml export and the generation of:
  • CIOMS I format reports
  • Line-listings
  • Summary tabulations
  • Key Performance Indicators (KPIs) reports

For any inquiry regarding our services, please contact Proge Medica team.

Provision of a National Person Responsible for Pharmacovigilance

Proge Medica can fulfil Marketing Authorisation Holder’s local obligations in Italy performing the local pharmacovigilance activities, including:

  • Appointment of PV Local Contact Point (PV LCP) and Deputy and their nomination to the Italian Competent Authority with 24/7 availability, where required
  • Weekly monitoring of locally published not indexed medical literature
  • Local processing of Individual Case Safety Reports (ICSRs), including reporting to the Head Quarters, where applicable
  • Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
  • Pharmacovigilance trainings to local Marketing Authorisation Holders personnel
  • National regulatory intelligence

For any inquiry regarding our services, please contact Proge Medica team.

Pharmacovigilance support in Clinical trials

Proge Medica team is able to provide clinical safety services such as:

  • Adverse Events (AE)/Serious AE (SAE) processing
  • Recording in Safety Database
  • Query management and follow-up
  • MedDRA coding
  • Case Narrative writing
  • Medical data review
  • SUSARs handling
  • DSUR preparation and submission

For any inquiry regarding our services, please contact Proge Medica team.

Pharmacovigilance Business Continuity on holidays

Proge Medica can provide back-up pharmacovigilance activities during Companies holiday closures to guarantee the business continuity through:

  • Case processing (ICSRs) and reporting
  • EudraVigilance ICSRs screening and selective import
  • Regular global and local medical literature monitoring
  • Regulatory intelligence

For any inquiry regarding our services, please contact Proge Medica team.

Pharmacovigilance Quality Assurance

Pharmacovigilance Audits

Proge Medica can provide an unbiased opinion of operational performance of the Pharmacovigilance system of Marketing Authorisation Holders, assessing the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations through:

  • Strategic audit plan development according to a Risk based approach
  • Tactical Audit Programme development according to a Risk based approach
  • Conduction of Pharmacovigilance and Quality assurance system Audits
  • Conduction of Audits on Pharmacovigilance and Quality assurance processes
  • Support in implementation of Corrective and Preventive actions

For any inquiry regarding our services, please contact Proge Medica team.

SOP and WI writing

Proge Medica can support the Marketing Authorisation Holders in the setting up of the quality control documents which provide detailed guidance in the execution of pharmacovigilance tasks through:

  • Standard Operating Procedures implementation and tailoring
  • Working Instructions implementation and tailoring
  • Gap analysis of the already existing quality control documents

For any inquiry regarding our services, please contact Proge Medica team.

Training

Proge Medica can perform coaching and training in pharmacovigilance to Marketing Authorisation Holders staff through:

  • In house advance pharmacovigilance training for safety staff tailored to their tasks, for example periodic reports, signal evaluation, risk management and pharmacovigilance regulations and requirements
  • Basic pharmacovigilance training to all Company personnel for regulatory expectations

For any inquiry regarding our services, please contact Proge Medica team.

Medical Device Vigilance and Surveillance

Medical Device Vigilance

Proge Medica can support the Manufacturer in the fulfillment of the European Medical Device Vigilance obligations through:

  • Medical Device Vigilance System set-up/improvement
  • Management of Medical Device safety information
  • Processing of a Medical Device Incident (MDI)
  • Reporting of MDI to the Competent Authorities
  • MDI reconciliation
  • Negotiation/update of Safety Data Exchange Agreements (SDEA)
  • Safety Database availability
  • Standard Operating Procedures implementation

Medical Device Post-market Surveillance System

Proge Medica can support the Manufacturer in establishment, documentation, implementation, maintainance and update of the Post-market Surveillance System of Medical Device required by Regulation (EU) 2017/745, through:

  • Literature Monitoring
  • Writing and managing of Post Marketing Surveillance (PMS) Plan
  • Set up/managing of Post Marketing Clinical Follow-up (PMCF) Plan
  • Development of Periodic Safety Update Reports (PSURs)
  • Contacts management with Notified Bodies

For any inquiry regarding our services, please contact Proge Medica team.