We can provide full pharmacovigilance services, or we can also provide selected services only. We provide great quality work with affordable rates for small to medium companies
Pharmacovigilance services and Drug Safety services provided by RVG Solutions
We provide end to end Pharmacovigilance services.
- Pharmacovigilance systems
- Pharmacovigilance Auditing
- EU QPPV provision
- LPPV services
- Inspection support
- UK QPPV provision
- Risk Management plans
- PEBRER/PAEDR
- Signal Detection and Statistical Analysis
- Brexit support
- (EXVMPD) – Product registration on the European Product Database
- Case processing and Reporting
- Global and Local Literature screening
- SOP writing
- Regulatory Intelligence
- Risk Management
Brexit:
QPPV for UK authorized products:
- For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates anywhere in the UK or in the EU/EEA, and is responsible for the establishment and maintenance of the pharmacovigilance system (“the UK QPPV”). Where the QPPV is not in the UK, there will be a need for a national contact person for pharmacovigilance.
UK National contact person for pharmacovigilance
- If you choose to establish a QPPV who resides and operates in the EU/EEA, you must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. This individual should have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
UK PSMF
- For all UK national MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the MAH must maintain, and make available upon request of the MHRA, a PSMF that describes the pharmacovigilance system for UK authorised products.
- From 1 January 2021, for products in respect of Northern Ireland (UK-wide and Northern Ireland-only MAs), in addition to notifying the QPPV and PSMF details to the MHRA, you must submit information on the UK QPPV and the EU location of the UK PSMF to the Article 57 database in accordance with Regulation (EC) No 726/2004 Article 57(2).
- Please contact us for UK specific Pharmacovigilance services.
Signal Detection:
Identification and evaluation of safety signals
- A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.
Methods in signal detection:
- Quantitative analysis of spontaneous ADRs is routinely used in Pharmacovigilance. The most common methods are, the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC) and empirical Bayes geometric mean (EBGM). There are other methods of signal detection.
Signal validation:
- The process of evaluating the data supporting the detected signal to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.
- This evaluation should consider the strength of the evidence, the clinical relevance and the previous awareness of the association. The extent of evaluation performed during signal validation versus further assessment may vary according to the organisation’s internal procedures.
- Looking for a specialist to put in place your signal management procedures?
- Speak with a member of our team!
Risk Management Plan:
A risk management plan (RMP) is a set of activities designed to identify and prevent or minimize risks related to medicine. An RMP is written by a MAH and is continually updated throughout the lifecycle of medicine as the understanding of a risk increases and the missing information decreases.
Risk minimization measures are interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimization measures and assessing their effectiveness are key elements of risk management.
Routine Risk Management activities:
- For most of the products, routine activities are sufficient. Routine activities include
- SMPC
- Patient leaflet
Additional Risk Management activities:
- Additional risk minimization activities should only be introduced when they are deemed to be essential for the safe and effective use of the medicinal product. Additional risk minimization measure includes:
- – controlled access program
- – educational programs
DHPC:
- A direct healthcare professional communication (DHPC) is a communication intervention by which important information is delivered directly to individual healthcare professionals by a marketing authorisation holder or by a competent authority, to inform them of the need to take certain actions or adapt their practices in relation to a medicinal product
- Implementation of Risk minimization measures
- Additional risk minimization measures can consist of one or more interventions that should be implemented in a sustainable way in a defined target group. Careful consideration should be given to both the timing and frequency of any intervention and the procedures to reach the target population.
- For example, a one-off distribution of educational tools may be insufficient to ensure that all potential prescribers and/or users, including new prescribers and users, are reached. Additional periodic redistribution of the tools might be necessary.
- Effectiveness check of the risk minimization measures:
- Evaluating the effectiveness of additional risk minimization measures is necessary to establish whether an intervention has been effective or not and if not why and which corrective actions are necessary. The evaluation should be performed for the additional risk minimization tools individually and for the risk minimization program.
PSUR/PEBRER:
- PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization.
- The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, considering new or emerging safety information in the context of cumulative information on risk and benefits.
- We can help you to prepare PSUR for your complex product. We stay up to date with the current regulations. If COVID-19 vaccine is in your portfolio then we can also support create PSUR for COVID-19 vaccine as there are specific requirements for COVID-19 vaccine
EU QPPV:
- Appointing a European Union 9EU) Qualified Person for Pharmacovigilance (QPPV) is a mandatory requirement for all medicinal products authorized in the European Union [DIR Art 104(3)(a)]. The EU QPPV role is critical as this qualified person is the primary contact for PV enquiries from Regulatory Authorities. The QPPV has oversight of the entire PV system. The QPPV should reside in EU and may also reside and operate in Norway, Iceland or Liechtenstein.
- Each pharmacovigilance system can have only one QPPV. A QPPV may be employed by more than one marketing authorisation holder, for a shared or for separate pharmacovigilance systems or may fulfil the role of QPPV for more than one pharmacovigilance system of the same marketing authorisation holder, provided that the QPPV is able to fulfil all obligations.
- The marketing authorisation holder shall ensure that the QPPV has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities [IR Art 10(1)]. The QPPV should have skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics.
PSMF:
- PSMF is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products. It is the core document which will contain all Pharmacovigilance information for the MAH. The regulatory authorities will always request a PSMF as soon the MAH has been notified of the inspection.
Literature screening:
- Literature sources are 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. MAHs are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases. The expectation is that the literature searches should be conducted every week.
- Medline and Embase are most commonly used literature search databases used.
Inspection support:
- A pharmacovigilance inspection is announced as soon as product approval has been received. We provide inspection support for all inspections. We will be able to help draft responses, position statement and advice on overall management of the inspection. Our panel of consultants has experience dealing face to face with the inspector and has understanding of working practices for majority of regulatory authorities.
