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Pharmacovigilance

Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis and regulatory surveillance, which in turn has increased costs. You, therefore, need a strategic partner with process expertise–one who can minimize your cost pressures while unlocking value and maintaining compliance

The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfil the stringent obligations. Covalent tech Pharmacovigilance team is comprised of Medical & healthcare professionals with vast experience in both direct patient care and industry-specific Pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.

Clinical Trial Safety:
  • Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
  • SAE processing within required timeframes in client's database (e.g. Clintrace™ and ARISg™, Argus Safety Database) and other non-commercial systems.
  • Qualified medical review of all SAEs for data completeness and medical sense
  • Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
  • Regulatory reporting to authorities, investigators and ethics committees
  • Electronic safety reporting according to ICH E2B
  • Preparation and submission of annual safety reports (ASRs)
  • Data reconciliation of Pharmacovigilance and clinical trials databases
  • Writing of patient safety narratives for study reports
  • Project-specific standard operating procedures (SOPs)
  • Compliance monitoring
  • SAE training for investigators and monitors
Post Marketing Safety:
  • Processing and reporting of adverse drug reactions (ADRs) from the post marketing area In Covalent tech Labs global safety database.
  • In client‘s database via remote access
  • Electronic safety reporting according to ICH E2
  • Compliance monitoring
  • Preparation of periodic safety update reports (PSURs)
  • Evaluation of signals with respect to the need to update the Company Core Safety Information (CCSI)
  • Periodic signal detection activities for medicinal products with a marketing authorization
  • Literature review in collaboration with a dedicated literature service provider
  • Preparation and Update of risk management plans (EU-RMP)
Global Drug Safety Database:
  • Our global drug safety database provides you with a tailor-made and cost-effective drug safety solution for small- and mid-size pharmaceutical companies.
  • Complete PV software system
  • Web-based tool to capture, manage, evaluate and report ICSRs according to regulations and internal needs; custom made workflow and user groups
  • Validated and 21 CFR part 11-compliant environment
  • Global regulatory reporting pre- and post-marketing (CIOMS I form, Med Watch form, etc.)
  • Electronic safety reporting according to E2B standard (XML message)
  • E2B interchange module (from 2011 onwards)
  • Validated reports for data retrieval and compliance report
  • Regular MedDRA updates
  • Extensive quality control built-in (field validation, pre-save and post-save checks)
  • Client-specific database instances
EUDRAVIGILANCE:
Eudravigilance Medicinal Product Dictionary (EVMPD):

The EVMPD has been developed by the European Medicines Agency in collaboration with the EudraVigilance implementation fora. The main objective of the EVMPD was to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.

Extended Medicinal Product Dictionary (XEVMPD)

In December 2010 new pharmacovigilance legislation amending existing legislation was adopted in the European Union (EU) resulting in the need to update the EVMPD in accordance with the format for of the electronic submission of information on medicines published by the Agency on 1 July 2011. Based on the new format, the EVMPD has been re-branded as Extended Medicinal Product Dictionary (XEVMPD), enabling the Agency to:

  • Create a list of all medicines authorised and registered in the EU
  • Identify medicines accurately, especially medicines included in reports of suspected adverse reactions
  • Co-ordinate the regulation and safety monitoring of medicines across the EU
  • Use of the Extended EudraVigilance Investigational Medicinal Product Dictionary (XEVIMPD) for Sponsors of clinical trials
New Guidance

An update arrived from EMA on 7thNovember with some new guidance. At first glance it looks pretty innocuous: just a few files labelled “Controlled vocabularies quality control” and the typical updated vocabulary files:

EMA is preparing ground for handling variations – “Invalidate MA” code is introduced to facilitate change in market authorization holder, renew an authorization, and even a code for variations. However, for variations it is specifically listed as not usable until new guidance is issued. So at least you can sell a product to another company, and update for renewals.

With a new field is being added, there will be a new XML schema (which has not yet been released): Previous EV codes can now be used to refer to previous authorized products and development products. That means that the schema has to support both a development and authorized EV code – a choice in the XML schema.

The controlled vocabularies for substances, dosage forms and routes of administrations are being cleaned up. As a result everything will need to be resubmitted again between June and November of 2014.

XEVIMPD

On 11 June 2011, the Commission published in the Official Journal (OJ 2011/C 172/01) a Communication on the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’).

In this context sponsors should provide, before completing the clinical trials application form, information on the Investigational Medicinal Product (IMP) in the Extended EudraVigilance Investigational Medicinal Product Dictionary (‘XEVIMPD’).

This is expected to be put into place late 2015 or early 2016 keep watching this space for more updates.