AER & ICSR Management.
For all your Global, Local & Veterinary case reporting needs.

What is AER & ICSR Management?

Adverse Event Reports.

An Adverse Event refers to an unintentional and unfavorable reaction to a medicinal product, whether for human or veterinary use, without considering any potential causal connection. When there is a reasonable belief of a causative link with a medicinal product, this is termed an Adverse Reaction (AR).

The responsibility for assessing and determining the potential causal relationship for the purpose of Adverse Event Reports (AERs) lies with the Marketing Authorization Holder (MAH).

Adverse event reporting (AER & ICSR Management) is a Regulatory requirement, and MAHs are responsible for monitoring, collecting, and reporting ‘valid’ suspected adverse events associated with medicinal products (medicines) or medical devices, including prescription and non-prescription over-the-counter (OTC), and managing the safety of all their medicines and medical devices during their use in healthcare practice.

AER data also provides a key role in assessing the Benefit-Risk profile of a given drug.

Reports can originate from various sources, including:

  • Healthcare professionals or patients
  • Patient support programs
  • Clinical or post-marketing studies
  • Literature sources
  • Media platforms including websites
  • Direct communication from Regulatory authorities

Special Reporting Situations (SRSs) also exist, where adverse events arise due to the use of a medicinal product outside the scope of its marketing authorisation, including:

Overdose or Lower dose: Use of the product below or exceeding the recommended authorized maximum dose, either individually or cumulatively.

Off-label use: Intentional use of the product for a purpose not within its intended use or authorized indication.

Misuse: Deliberate and inappropriate use beyond the product’s marketing authorization.

Abuse: Deliberate excessive use of a medicine, consistently or sporadically, resulting in harmful physical or psychological effects.

Occupational exposure: Contact with a medicine due to professional or non-professional occupation.

Medication error: Dispensing errors, accidental exposure, maladministration.

Lack of, or unexpected, therapeutic effect: Reporting when an additional benefit not previously known is observed.

Drug or drug-food interactions: Alteration of medication effectiveness or toxicity due to the administration of another medicine(s) or food intake.

Adverse events may also be reported through Product complaints (PCs) Including issues such as suspected product failure, damaged or missing medication, incorrect strength or color, damaged packaging, missing patient information leaflet, broken or damaged needles or syringes, and counterfeit medicines, among others.

Click for information from the EMA on AERs and reporting.

What is a valid ICSR?

Individual Case Safety Reports.

For regulatory pharmacovigilance purposes, Adverse Event Reports (AERs) that meet specific criteria are referred to as Individual Case Safety Reports (ICSRs).

To ensure the validity of ICSRs, Marketing Authorization Holders (MAHs) are responsible for conducting follow-up investigations to obtain any missing information required for their creation.

There are four minimum criteria that must be met for an AER to be considered a valid ICSR:

One or more identifiable reporter(s):

  • Designation (such as physician, pharmacist, or patient)
  • Name or initials of the reporter
  • Address details (including organization, department, street, city, zip or postcode, country)
  • Email or telephone/mobile number for contact

An identifiable patient or group of patients:

At least one of the following: initials, date of birth, age or age group, gender or sex

One or more suspected medicinal product(s) or medical device(s):

Identification of the medicinal product(s) or medical device(s), with reference to brand or generic names, where the commissioning client is the MAH.

A Suspected Adverse Event:

This includes both serious and non-serious Adverse Event Reports (AERs), Special Reporting Situations (SRSs), and Product Complaints (PCs).

In the EEA, reporting is done to the European Medicines Agency (EMA) via EudraVigilance.

Click for information from the EMA on EudraVigilance reporting.

Why choose Aegisana for your AER & ICSR Management?

A full processing service.

Aegisana supports each step of AER & ICSR Management and your global and local case processing, including end-to-end processing of all your non-interventional ICSRs and Clinical Trial SAEs, and other reportable adverse events of special interest.

From collection and translations to and from local languages, through to data entry, quality control, medical review, and regulatory submissions to concerned parties, we can manage your safety data and meet all your ICSR case processing requirements.

We process all relevant data from available source documentation according to robust data entry conventions and follow a risk-based approach to follow-up queries with coordination across stakeholders to ensure reporters receive consolidated requests.

Local Case Reporting.

We can handle all your local case reporting requirements with experienced pharmacovigilance personnel in-country or at-base. This includes the collection of ICSR information for handover to our global PV team or direct to client, ICSR/CIOMS form completion, local ICSR tracking with local IDs where applicable, safety mailbox management, and follow ups as requested by the Global team/client.

Global Case Reporting.

Our Global PV team ensures cases are processed in a fast, efficient, risk-prioritised manner through our safety database workflow and dashboards, with cases managed according to our client-agreed Safety Management Plans and timelines. All case reporting is subject to independent and documented Quality Control to ensure data entry integrity and continuous improvement.

MedDRA and VeDDRA coding.

We provide a complete and up to date Medical Dictionary for Regulatory Affairs (MedDRA) and Veterinary Dictionary for Drug Related Affairs (VeDDRA) coding service for the processing of all your pharmacovigilance and veterinary pharmacovigilance case reports.

In addition to MedDRA coding, we employ lookups for ‘always-serious’ lists including Important Medical Event (IME) and Designated Medical Event (DME) lists, as well ‘auto-expectedness’ lookups to ensure consistency in coding and assessment whilst reducing the risk of error.

Medical Review.

Our experienced safety physicians can evaluate all your case reports for:

  • MedDRA-coded terms review.
  • Assessment of the case narrative and company comment.
  • Conducting a Company/Sponsor Causality Assessment.

These evaluations can be conducted either independently, separate from your operations, or in seamless collaboration with your in-house safety physician or medical monitor.

Reconciliation.

We can perform reconciliation with relevant sources and 3rd parties including business partners, Medical Information and Product Quality, and we support any ongoing or final reconciliation between the Clinical and Safety Databases working together with your Clinical Data Management team.