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Helena van den Dungen
Director Pharmacovigilance

Helena joined Xendo from Novartis Switzerland, where she was the Global Head, Development Quality Chief Medical Office and Patient Safety. Her responsibilities included the Quality Assurance function for the Novartis enterprise-wide patient safety and pharmacovigilance system, covering all Novartis products throughout their life cycle, globally and in the countries as well as device vigilance and specific patient-focused activities.

Helena had joined Novartis in 2007 as Regional Head Clinical Quality Assurance (CQA) Auditing and subsequently became the Global Head of Country Management. In 2009 she became the Global Head of Drug Safety and Epidemiology Quality Assurance.

Prior to joining Novartis, Helena was a Senior Inspector at the Inspectorate of Health Care of the Netherlands (for GLP, GCP and PV and related regulated fields). In this role, she was responsible for the design, implementation, and execution of inspection and compliance programs for GLP, GCP, Pharmacovigilance, Ethics Committees and related regulated areas for the Dutch, European, and Global Health Authorities. Besides this, she also acted as a subject matter expert for various regulatory working parties for the Dutch Authorities and the European Commission.

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Understanding pharmacovigilance regulations and requirements, access to a wide range of services, and a senior expert team are repeatedly highlighted as essential criteria when clients select Xendo Pharmacovigilance as their flexible service provider. Working globally, we understand international requirements. Being consistently quality driven and customer focused has led to a proven track record of meeting or exceeding clients` expectations. We are also regularly asked to lecture or moderate at international seminars and symposia as experts in the field.

From the outset, we have been a full-service provider for pharmacovigilance. Due to a sound Quality Management System we ensure that all activities conducted for and on behalf of clients are in line with applicable standards.

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PV

Adverse Event Management (Argus)

Our dedicated Adverse Event Management team is optimally integrated with other Xendo teams, like  Medical Safety Science, Auditing, QPPV and Regulatory Affairs, combining over 25 years of experience. Additionally, we are experienced with the various agencies (including PMDA, Japan), and can ensure global compliance in an ever-changing regulatory landscape.This places us in the unique position to support our clients with an end-to-end solution to pharmacovigilance. 

In addition, we offer safety database hosting in our Argus MT Safety Database. Oracle Argus is regarded as the ‘golden standard’ pharmacovigilance safety database. By applying a multi-tenant approach and by using the Argus workflow manager Xendo has lean processes in place enabling us to offer this software as a cost-effective solution. With this state-of-the-art database, reports for case processing can be generated independently of the size of a corporation. With the Argus Safety Database, Xendo offers the wide scope of activities to biotech, pharmaceutical, and medical device companies of all sizes looking for a cost-effective Adverse Event Management solution.

As the system is very adaptive, all process steps can be managed by Xendo but clients can also choose to perform any of the steps internally (e.g. medical review, QC). Another option is that the client grants access to its own database, allowing our staff to process data in their database environment.

Read more about this cost-effective solution for case processing.

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Report writing (PSUR/PBRER, DSUR and RMP)

Our Medical Safety Science Team consists of experts with very broad experience in analysing and evaluating data and writing of required periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs) and writing of Risk Management Plans (RMPs) or Development Risk Management Plans (DRMPs). Reports are written in line with international regulatory requirements and guidelines and take into account specific requirements and recommendations from regulatory assessment reports. Our high-quality medical writing service includes full Project Management, including planning, time management, data requests, writing, quality control, strategic advice, communication, and evaluation.

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Quality Management System (QMS)

We emphasize the importance of good documentation practice and quality review of involved processes, systems, and outputs. Global regulators (incl. FDA, EMA & PMDA(Japan)) require that pharmacovigilance has its own QMS which should be fit for the organisation and its products.

Next to their work experience and PV knowledge, our consultants understand the Lean Six Sigma principles and the need to manage budgets. Therefore, they can assist you in designing and implementing your PV QMS and to create accompanying documents such as SOPs, Quality Manuals and work instructions in an efficient risk-based manner. Through this integrated approach, your entire PV systems will be compliant with global regulatory requirements, enhancing patient safety.

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Audits & Inspections Readiness

Over the past years, competent authorities have increased and intensified their regulatory inspections. As our Senior Xendo staff also function as QPPV they are regularly involved in individual regulatory inspections and understand how to audit compliance with EU regulations. Besides broad PV system audits, we also have substantial experience in specific system audits (MedDRA coding, planning and generation of periodic reports, local affiliates, etc). Our audit methodology is very similar to the approach taken by competent authorities and ensures that clients are well prepared for inspections.

As support to clients during their preparation for these inspections, we have developed a proven concept for inspection preparedness training to ensure that staff is aware of what is expected during interviews and how to present the company and themselves during an inspection. Training includes mock interviews and feedback on preparation in terms of issue handling and to anticipate questions and how to relate to them in the context of individual tasks and responsibilities.

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QPPV Office & Local EU Network

Marketing Authorisation Holders active in the EEA are required to appoint an EU QPPV and a deputy QPPV residing in the EEA. Selected senior Xendo staff are qualified to take on these responsible roles ad interim and are fully aware of the considerable responsibilities involved.

They fulfill QPPV roles in the EU for various small and medium sized companies based e.g. in the EU, Japan, and the USA. In addition to the QPPV position, we also offer a European network of local persons responsible for PV in most EU countries as required by their local legislation.

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Signal management

Integrating signal management in your PV system offers many challenges such as defining the most appropriate signal detection methods and periodicity for your product portfolio, managing signal volume, prioritization, and timing of signal detection, conducting signal evaluations, good documentation practices, and taking timely and appropriate action. Our staff members have extensive experience in all areas of signal management. They can support you in any or all of these areas, the setup of an appropriate process, tailored to your product portfolio. A well designed and implemented signal management process will support you in risk management and periodic report writing as well as risk-minimization planning.

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Literature search (Global & Local)

We offer cost-sharing solutions for global search engines accessing Embase and Medline. We have extensive experience in developing search strategies for our clients and providing results from these searches according to an agreed periodicity. The focus of these searches can be aimed at the identification of adverse drug reactions, to identify signals, to select literature relevant for inclusion in periodic reports, or to identify literature for a specific topic of interest. We also support our clients in the assessment of the identified literature and efficient and auditable documentation of the results. For substances that are part of any of the substance groups that are covered by EMA Medical Literature Monitoring (MLM), we can perform weekly checks using the ICSR Export module. Also performing literature searches in relevant local journals can be part of our service.

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Risk Management

One of our strengths is the availability of staff with a very broad PV knowledge base and a variety of backgrounds from having worked in e.g. the (bio)pharmaceutical industry, at regulatory authorities, in academic settings and consultancy organisations. With these backgrounds and education in medical, pharmaceutical, pharmacological, and various other life sciences such as epidemiology, we can support you with strategic advice in risk management and benefit-risk assessments, also in collaboration with our experienced colleagues in our Regulatory Affairs division.

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PV Training

Our staff regularly conduct tailored training on all aspects of pharmacovigilance at the request of our clients as well as conducting plenary training sessions and workshops if requested. For example, based on our experience we have developed a successful PV awareness training module for all staff.