Holitas Limited provides a range of pharmacovigilance services to support generic and innovative pharmaceutical companies of any size.

Its expert and qualified personnel will ensure the necessary PV work and systems are in place to guarantee that companies comply with the legislation.

We aim to take the worry and cost that can result from non-compliance away, by providing the needed resource at competitive prices.

Adverse Drug Reaction Management

Holitas Limited has the expertise and facilities to provide the complete service for ADR management.

The ADR management service includes:

  • Initial receipt, assessment and triaging of ADR cases
  • Data coding of the ADRs, including MedDRA coding
  • Medical review of cases by a fully qualified drug safety physician
  • Follow-up of cases
  • Reporting expeditable cases to the Regulatory Authorities
  • Providing all ADR cases for line listings, periodic reports and signal detection purposes

Electronic reporting to the Regulatory Authorities

The Holitas Managing Director has successfully registered several pharmaceutical companies on EudraVigilance.

The Managing Director passed the EMEA EudraVigilance Course in January 2008 and has continued to be involved with the electronic reporting process. She also successfully completed her training on the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) in June 2012.

Holitas Limited is pleased to offer the following services:

  • Registration on EudraVigilance on behalf of the pharmaceutical company
  • Electronic transmission of adverse drug reactions to Regulatory Authorities through EVWeb
  • Input of medicinal products on to the Extended EudraVigilance Product Dictionary (XEVMPD)

Literature Searches

The scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week.

Holitas Limited will perform a weekly search on Medline (and other databases if stipulated) on behalf of the MAH.

Our experienced personnel will review the literature search results to identify both individual cases which may qualify for expedited reporting and also safety studies which are relevant to the safety profile of the medicinal product and need to be discussed as part of the continuous review of safety data and should also be included in the next PSUR.

In addition literature searches can be run at the data lock point (DLP) of a PSUR, in order to capture all possible articles that may be of relevance to the medicinal products’ risk/benefit profile for the period covered by the PSUR.

Pharmacovigilance Reports

There are a number of essential legislated reports required from the MAH or Sponsor by the Regulatory Authorities as part of the pharmacovigilance system. These are:

  • The periodic safety update report (PSUR)
  • The development safety update report (DSUR)
  • The Pharmacovigilance master file (PSMF)
  • The risk management plan (RMP)

Holitas Limited’s experienced personnel, who have written and reviewed an extensive number of these reports during their pharmaceutical careers are here to both advise MAHs and Sponsors when these reports are required and to write and medically review them.

In addition we can co-ordinate and oversee the due dates of the above mentioned PV reports in order to efficiently allocate resource and ensure that the reports are submitted to the Regulatory Authorities within the legislated timelines.

Writing SOPs

Standard operating procedures (SOPs) are an essential component to all pharmacovigilance systems, whereby all the legislated requirements of a PV system can be governed by good written procedures. Therefore, it can be demonstrated that the MAH has an understanding of what is required and that relevant personnel are performing the necessary tasks in a consistent manner.

Holitas Limited’s personnel have numerous years of experience in writing SOPs, in particular the Managing Director has written a complete set to govern their own PV system and has extensive experience in writing SOPs for MAHs.

Pharmacovigilance Training

The legal requirement for quality systems was introduced by Directive 2010/84/EU and Regulation (EU) No 1235/2010. Part of a quality system is a robust training schedule for company staff.

Staff should be appropriately trained for performing pharmacovigilance related activities. This includes not only staff within the pharmacovigilance units but also staff who may receive or process safety reports, such as sales personnel or clinical research staff.

Holitas Limited’s experienced personnel provides pharmacovigilance training tailored to each client’s needs, whether it’s basic PV training on recognising an ADR or more advanced training on aspects of the current PV legislation.

Pharmacovigilance audits

All MAHs have to conduct quality assurance auditing of their pharmacovigilance system, including auditing of sub-contractors.

Holitas Limited’s Managing Director has extensive experience working in the pharmacovigilance industry and has conducted PV audits for clients both routinely and pre-inspection.

Holitas Limited’s expert personnel understand that an audit of the client’s PV system gives support to the quality of their system, by identifying any problems and offering solutions. Holitas Limited provides the following services:

  • Routine audits
  • Pre-inspection audits

The service includes extensive review of relevant documentation of the company’s PV system, time on the client’s site interviewing personnel and further document review and a comprehensive audit report of the PV system, highlighting any issues identified and suggested remedial action.

When the audit is a follow-up to a previous audit, review of any previous issues identified and stated changes would also be made.

Qualified Person for Pharmacovigilance (QPPV)

The QPPV is an essential component to a PV system. Holitas Limited provides a QPPV service.

Together with the MAH’s full support, Holitas Limited can provide the qualified personnel to take on the roles of QPPV and deputy QPPV in order to meet the legislative requirements.

Continuous review of safety data-Signal detection

As part of any pharmaceutical company’s pharmacovigilance system, signal detection is key in order to identify changes in the medicinal Product’s benefit-risk profile at an early stage.

Holitas Limited’s personnel have gained considerable experience in reviewing safety data for signals, whilst working in the pharmacovigilance industry.

The process will include:

  • Continual assessment on a day by day basis
  • Periodical review to identify any possible safety signals
  • Agreed regular meetings with the client
  • Written reports
  • Meeting minutes

Holitas Limited will work closely with the client when identifying any possible safety signals.

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