• After analyzing the costs, the resources demanded, such as staff, equipment, and facilities are more expensive than outsourcing.
• The skillset necessary (clinical, scientific, customer service, etc.) is not available in-house or recruitable in the necessary timeframe.
• Appropriate work procedures, tracking systems, training programs and/or auditing processes are not in place.
• The schedule for getting the service up to speed does not allow enough time to create a quality program.
• Based on workloads and the level of service demanded, in-house workers would be inefficiently idle.
• The department has a temporary staffing deficit due to illness, maternity leave, etc.
• You or your team are unfamiliar with the regulations, both existing and emerging. This is particularly relevant when expanding product distribution internationally.
• The risks of sourcing PV and MI services in-house are too high, potentially leaving the company exposed.
• Key points in the product lifecycle demand either high activity (such as at the start of a clinical trial) or low activity (during the end of the product lifecycle).

Keep in mind that outsourcing is not “out-of-mind sourcing”. Regardless of whether you manage your PV and MI program or outsource, you as the product owner or sponsor are responsible for the safety surveillance process and the outcomes.

1. During the revision process, international regulatory guidance documents on vigilance and post-market surveillance developed by the Global Harmonization Task Force were considered and transposed into the European regulatory context.
2. Obligations of the European medical device database EUDAMED and its interaction with the Competent Authorities were outlined. For example, the guidelines now include a mandate to utilized EUDAMED for the distribution of National Competent Authorities reports among NCAs and the European Commission.
3. A Manufacturer’s Periodic Summary Report Form was developed. This form can be used by the Manufacturer or Authorized Representative when periodic reporting schemes have been agreed with a National Competent Authority.
4. A manufacturer’s Trend Report form was developed.
5. Two existing Reports Forms were updated: a) Report Form Manufacturer’s Incident Report and b) Manufacturer’s Field Safety Correction Action Report.
6. The following example of what is not considered to be an incident listed under “Protection against a fault functioned correctly,” was updated and the following statement was added: “An intervention by the user or an immediate remote intervention by the manufacturer allowed the device (analyzer) to resume its function (analysis), resulting in correct results.”
7. Annex 1 was updated to include, in addition to Incidents, specific examples of Field Safety Corrective Actions.

A full PDF version of the guideline document can be found on the MEDDEV website.

Administration:
The drug license holder is obliged to assign a pharmacist Qualified Person for Pharmacovigilance (QPPV) and to implement a system for tracking and evaluating adverse events (AEs) and new safety information for each pharmaceutical product.

Reporting to the Health Ministry:
Reports must be submitted within 15 days through the Assigned Pharmacist by the QPPV on:

• Every new notification that relates to pharmaceutical product safety published by the FDA, EMA or the authority that issued the Certificate of Pharmaceutical Product (CPP)
• New safety information that was published in English professional or scientific literature
• New information from safety reports issued by the manufacturer or license holder
• A deviant AE for which there is suspicion that the AE frequency is higher than known levels
• One or more serious AEs discovered in Israel, that:
  • Are suspected to have caused death, paralysis, severe limitations or life-threatening conditions
  • Required significant medical care
  • Caused a birth defect when the drug was taken during pregnancy
  • Caused the problems stated above regardless of whether they were reversible
• Adverse events, lack of efficacy, toxicity of a new medicine formulation in Israel that was discovered during the first 12 months of drug marketing in Israel
• AEs that were reported in Israel that were not documented in the Israeli physician prescribing information, or Summary of Prescribing Characteristics (SPC)

Monthly reporting – reporting on adverse events with deviation in frequency
The Assigned Pharmacist or QPPV must perform a monthly review of AE reports relative to usage or sales information, and report to the Ministry of Health if there was an increase compared to the recent year in Israel or international data.

Periodic Safety Update Report (PSUR)
The Assigned Pharmacist or QPPV must submit to the Health Ministry a summary report and conclusions from the periodic safety report regarding every pharmaceutical product, just as the international authorities require. This information must be submitted with a signed declaration after reviewing the complete report.

Reporting principles
The Assigned Pharmacist or QPPV must verify that the report is valid and contains the details required according to EU good Pharmacovigilance practices (GVP).