Using our experience and knowledge to guide you through the complexities of Pharmacovigilance.
Fully understanding your needs and expectations inspires our TEAM to exceed them.
Choose PDS as your PV outsource service provider and you will benefit from working with a highly dependable partner, with the right levels of knowledge and experience to guide you through the complexities of Pharmacovigilance.
PDS has over 60 years’ experience working alongside national and international Pharmaceutical and Biotech companies. Our highly experienced and dedicated TEAM can help you across all phases of drug development from Phase I through to Phase IV for innovative drugs, to generics, as well as medical devices, herbal products or cosmeceuticals.
Call on us to help with the key areas where you most need support and maximise your return on investment. Our dynamic pharmacovigilance services allow you choose the support you need, exactly when you need it. We will always endeavour to bring solutions to the table in a timely manner, rather than simply sit back and try to fix problems when they occur. PDS’s clients benefit from our forward thinking, proactive and collaborative way of working.
Case processing involves:
- Receipt of adverse event form
- Tracking of case
- Follow-up on correspondence with the reporter to obtain additional information
- Data entry
- MedDRA coding
- Reporting to relevant authorities (where necessary) of all individual case safety reports (ICSRs) received by the marketing authorisation holder.
- PDS will assess your company’s needs in terms of volume of cases and advise of the most appropriate pharmacovigilance system.
- If you do NOT already have a PV system, PDS will provide you with a user-friendly and low cost database without compromising the quality and compliance of your data. PV247.
- Certain ICSRs need to be reported with a matter of urgency (within 15 calendar days) to the relevant competent authorities.
- MAHs are expected to comply with the reporting timeframes and report in the correct format demanded by the country(ies) that require the report.
- PDS can provide this service through automated E2B reporting with the use of xml files or direct data entry into the EMAs EudraVigilance ICSR reporting tool, EVWEB.
- Monthly compliance data will be provided to each client in the form of a monthly report. This report will be helpful for when you will be reviewing your PSMF.
- PDS will respect the timeframes for reporting while offering reports of the best quality.
PBRERs, PSURs and DSURs
- Regulatory authorities require continuous proof that the Pharmacovigilance system and monitoring procedure you have in place for your products is working in the best interest of the patient.
- Since 13 June 2016 the submission of all PSURs have to be made to the EMA’s repository. This applies to all products.
- The Pharmacovigilance team at PDS have experience in writing and checking all the reports your company needs to stay compliant.
- PDS can help you with the writing and submission of reports. We will also assess their compliance as well as help you prepare the Company Core Safety Information (CCSI) document that should accompany the reports.
- We can help you determine if a PSUR is required or not. Where a PSUR is necessary then we can help work together to develop this and ensure all information is accurate and approved by your QPPV.
Pharmacovigilance System Master File (PSMF)
- The Pharmacovigilance System Master File is a legal requirement within the EU. The purpose of the PSMF is to describe the pharmacovigilance system and document its compliance with the requirements.
- PDS will provide you with as much or as little support as you need to develop and maintain your PSMF along with any needed submission.
- Module II – Pharmacovigilance System Master File of the EMA Good PV Practices details the requirements of this document.
When do I need to perform literature searching and for how long?
- Most commonly literature search is run once a week from the moment you submit the application for marketing authorisation until your product is withdrawn from the market.
What should I do with the information obtained from literature?
- All ICSRs need to be held within your PV system and reported appropriately.
- Any significant safety findings need to be dealt with appropriately, logged in your PV system, reported to the relevant authorities, and also will be included within your PSUR for the product.
All these activities need to be completed within certain timescales so each MAH needs to understand the process and who / which departments in your company need to be made aware of the findings from the literature.
PDS can provide as much or as little support on this as you require.
- PDS can help you analyse and assess the need for raising a signal detection process.
Risk Management Plan (RMP)
- Module V of the GVP Guidelines together with the ICH E2E emphasise the importance of a well-established and well prepared RMP.
- PDS will support you in writing this mandatory document for your product whether this is a generic or an innovator one.
EEA Qualified Person for Pharmacovigilance (QPPV)
In order to hold a marketing authorisation within the European Economic Area (EEA) a Qualified Person for Pharmacovigilance (QPPV) is a necessity. The Qualified Person for Pharmacovigilance is personally responsible for the fulfilment of the following key functions:
- Establish and maintain the Market Authorisation Holder’s (MAH) Pharmacovigilance System (including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities).
- Oversee the safety profiles of the company’s licenced products and any emerging safety concerns.
- Ensure the quality of the PSMF.
- Act as a single point of contact for the Regulatory Authorities on a 24-hour basis, and provide the contact point for pharmacovigilance inspections
- Your QPPV must have oversight of all relevant aspects of PV – systems, SOPs, contractual agreements, compliance data as well as ensuring all PV personnel are trained in matters of regulations and protocols.
- PDS can provide you with a reliable and experienced QPPV that will act in the best interest of your product and company.
Quality system for pharmacovigilance
What is a pharmacovigilance quality system?
The quality system is part of the pharmacovigilance system which consists of its own processes. It should cover organisational structure, responsibilities, procedures, processes and resources of the pharmacovigilance system as well as appropriate resource management, compliance management and record management (EMA Guideline GVP – Module I).
PDS will help you by ensuring the overall quality objectives with respect to pharmacovigilance are achieved:
- Complying with legal requirements
- Preventing harm from adverse reactions following the use of medicinal products
- Promoting safe and effective use of medicinal products
Our team of Pharmacovigilance experts can either review and update your existing process documentation or develop new documents to meet your needs. These include, but are not limited to:
- Pharmacovigilance System Master File (PSMF)
- Training plans and records
- Disaster recovery and business continuity plans
- Safety Data Exchange Agreements
- Risk Management systems
- Risk minimisation plans
Device Vigilance Reporting
Medical device vigilance follows different legislation to that for medicines and therefore how you handle events associated with devices is different. However, like pharmacovigilance, the purpose of device vigilance is to protect the safety and well-being of patients and users of such products.
The team at PDS has experience in reporting incidents to relevant competent authorities associated with the use of devices. We can help evaluate incidents and implement the necessary corrective and preventative actions. Likewise the team can help with evaluating which events should be reported and those which should not, in line with the current Medical Devices Directive (93/42/EEC).
EU regulations require all PV staff to be appropriately qualified for their role and demonstrate the required level of competence.
Each PV professional must also have an up to date documented training record. PDS has provided pharmacovigilance training to pharmaceutical companies and their PV professionals for over ten years. Our training portfolio covers the complete spectrum of pharmacovigilance, meaning we are able to tailor training for people of all levels of knowledge and experience.
PDS can provide:
- General pharmacovigilance training on key aspects of pharmacovigilance such as regulations, drug safety, clinical trials, PSURs/PBRERs, the importance of identification of AEs/ADRs.
- Topic specific trainings, on demand, in-house or via webinar e.g. Audits and inspections, Risk Management Plans, Signal Detection.
Audits and Inspections
Audits and Inspections – detailed information on Pharmacovigilance Audits can be found in EMA Good PV Practice: Module IV – Pharmacovigilance audits.
With extensive experience of supporting internal audits and regulatory inspections PDS offer:
- Training on audits and inspections, an objective review to current systems, processes and documentation to highlight weaknesses or gaps
- Pre-inspection support to help you prepare fully before a regulatory authority inspection
- Provide necessary support during the inspection and any support required with the implementation of any actions identified
Why do I need PV throughout a clinical trial?
PDS can provide all necessary support during your clinical trial programme, including appointing a responsible person, 24 hour cover, follow up of SAE reports, expedited reporting to relevant authorities and reconciliation activities.
- Appointing a responsible person
- 24 hour cover
- following up of SAE reports
- expedited reporting to relevant authorities
- reconciliation activities
Prior to the commencement of your clinical trial programme a senior member of the team will establish your needs and document within a Management Plan how your PV process will work.
Have a question? Need a Pharmacovigilance partner? Just call +44 (0) 1476 512395 or email firstname.lastname@example.org
Glossary of Terms
AE : Adverse event
ADR : Adverse Drug Reaction
CIOMS : Council for International Organisations of Medicinal Sciences
CSM : Committee for Safety of Medicines
EDI : Electronic Data Interchange
EMA : European Medicines Agency
EudraCT : European Clinical Trials Database
EVPM : EudraVigilance Post-authorisation Module
EVCT : EudraVigilance Clinical Trial Module
FDA : USA Food and Drug Administration
GCP : Good Clinical Practice
ICH : The International Conference on Harmonisation of Technical requirements for Registration of Pharmaceuticals for Human Use
ICSR : Individual Case Safety Report
IMP : Investigational Medicinal Product
ISO : International Organisation for Standardisation
MAH : Marketing Authorisation Holder
MedDRA : Medical Dictionary for Regulatory Activities
MHRA : Medicines & Healthcare products Regulatory Agency
NPSA : National Patient Safety Agency
PMS : Post-marketing surveillance
PSUR : Periodic Safety Update Report
SSAR : Suspected Serious Adverse Event
SUSAR : Suspected Unexpected Serious Adverse Reaction