NDA Regulatory Science Ltd.

Leatherhead, United Kingdom

NDA Regulatory Science Ltd.

Leatherhead, United Kingdom
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Furlan G.,Damastown Industrial Center | van Leeuwen B.,Astellas Pharma Europe B.V. | Edwards B.,NDA Regulatory Science Ltd
Pharmaceutical Medicine | Year: 2017

Over the last approximately 20 years, the pharmaceutical industry has increasingly outsourced its research and development activities, including pharmacovigilance, with mixed results. To avoid significant failures, both clients and service providers should understand and openly discuss each other’s needs, avoiding the unrealistic expectations often elicited prior to signing a contract. Clients should ensure the outsourced project is adequately resourced in terms of time allocated to it and the skills and expertise of those who will do the actual work and training. They should recognise that quality can be compromised by cheapness and that a service provider’s physical distance and cultural difference are likely to interfere with communication and reciprocal understanding. Clients should always have a person in house who has a good knowledge of pharmacovigilance, so as to understand each activity in detail. This person should be involved in discussions with the service provider, assessing the support and information that the service provider requires, reviewing the vendor’s work, providing continuous feedback and avoiding confrontation by focussing on the needs and challenges the service provider is facing. © 2017, Springer International Publishing Switzerland.


Miossec P.,University of Lyon | Verweij C.L.,VU University Amsterdam | Klareskog L.,Karolinska Institutet | Pitzalis C.,Experimental Medicine and Rheumatology | And 17 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number of treatment targets and options. A growing number of biologics as well as small molecules are already in use and there are promising new drugs in development. In order to make the best use of treatment options, both targeted and nontargeted biomarkers have to be identified and validated. To this aim, new rules are needed for the interaction between academia and industry under regulatory control. Setting up multi-centre biosample collections with clear definition of access, organising early, possibly noncommitting discussions with regulatory authorities, and defining a clear route for the validation, qualification and registration of the biomarker-drug combination are some of the more critical areas where effective collaboration between the drug industry, academia and regulators is needed.


Edwards B.,NDA Regulatory Science Ltd | Hugman B.,Uppsala Monitoring Center | Tobin M.,Impact Technologies, LLC | Whalen M.,Impact Technologies, LLC
Drug Safety | Year: 2012

Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust. The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data. Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products. © 2012 Adis Data Information BV. All rights reserved.


Furlan G.,EU QPPV Helsinn Birex Pharmaceuticals | Edwards B.,NDA Regulatory Science Ltd | Mastroianni A.,Aros Performance Management | Koski G.,Alliance for Clinical Research Excellence and Safety ACRES
Pharmaceutical Medicine | Year: 2016

Clinical research is at a cross-roads of sustainability due to the current cost of development, amount of regulation, and irrational use of medicine. There are also too many silos in clinical research and development, post-marketing safety, as well as a lack of standards, and effective communication. This paper covers the future of pharmacovigilance and argues that it needs to re-focus and not be a silo in the last phase of clinical research. In fact, the integration of pharmacovigilance is an integral part of much needed change in clinical research and development based on the application of systems thinking. Clinical research and development must improve as a whole system through the synergy of all parts. © 2016, Springer International Publishing Switzerland.


Klepper M.J.,MD LLC | Edwards B.,NDA Regulatory Science Ltd
Drug Safety | Year: 2011

Background: The building blocks of a pharmacovigilance system depend primarily on good quality individual case safety reports (ICSRs), which are stand-alone summaries describing one or more suspected adverse reactions that occur while a subject is taking either an investigational or marketed medicinal product and may require expedited reporting to regulatory authorities. For regulatory reporting purposes, the information of an ICSR is usually captured on forms such as MedWatch 3500/3500A, CIOMS I, Vaccine Adverse Event Report System (VAERS) or Adverse Events Following Immunization (AEFI). ICSRs that are sent electronically must meet the standards for electronic transmission specified in the International Conference on Harmonisation (ICH) E2B (R2) guideline. In filling out these regulatory forms, there are some areas of ambiguity. One of these is what the 'date of event' (MedWatch) or 'reaction onset date' (CIOMS) is interpreted to be. Objective: The aim of the survey was to determine the uniformity of responses for the onset date of an adverse reaction. Methods: A pilot and three surveys of pharmacovigilance professionals were undertaken between February and July 2009 to determine the range of responses for the onset of an adverse reaction. A narrative of a subject admitted to hospital with a diagnosis of pneumonia was presented and the respondent was asked to pick the date of onset of the adverse reaction. Results: The total number of respondents was 129. The results of the surveys indicated there was considerable variation in responses. These differences were based on different perspectives regarding the suspected adverse reaction. Some viewed the 'reaction' to be the first onset of signs and symptoms (even if nonspecific), others considered the onset of the reaction to be the date of the diagnosis, while others considered the date to be when the reaction became serious. Conclusion: By means of a survey, we have illustrated an example of the variability of determining the onset date of a suspected adverse reaction, and recommend that a criterion for onset time, i.e. beginning of signs or symptoms of the event, or date of diagnosis, be chosen as the standard. Once decided, this information should be incorporated into the company's case assessment documentation and staff appropriately trained, thus ensuring consistency across cases and minimizing the time spent in determining what date to use. © 2011 Adis Data Information BV. All rights reserved.


Edwards B.,NDA Regulatory Science Ltd | Chakraborty S.,University of Oxford
Drug Safety | Year: 2012

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances.The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a companys risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are used globally, we are not aware of any research into their effectiveness outside the ICH regions.What listed companies can communicate about benefits and risks is strongly influenced by the obligations of companies to the market and investors. There needs to be internal coordination for simultaneous release. Internal communications about significant issues should be restricted to those who know how to manage the risk of insider dealing from internal communications that may later be made public.Unfortunately, there is evidence that some companies do not have a cohesive strategy for communicating risk which should take into account all forms of promotional material and company-sponsored information sources on the Internet.A pharmaceutical company is not the only stakeholder responsible for communicating risks on their products. However, the relative roles and responsibilities of all relevant stakeholders are not defined and are often unclear. This means it is difficult to evaluate whether a companys actions might be duplicative or inefficient. We recommend that companies have a dedicated communications group whose role is to coordinate the companys communications strategy mapped to objectives that have been agreed with key stakeholders apart from just regulatory agencies. This same group can assess effectiveness of the communications, monitor audience reaction and adjust the communication strategy accordingly. © 2012 Springer International Publishing AG. All rights reserved.


Stanulovic V.,Semmelweis University | Stanulovic V.,Advanced Drug and Device Services SAS | Venegoni M.,Centro Regionale Of Farmacovigilanza Della Lombardia | Edwards B.,NDA Regulatory Science Ltd.
Drug Safety | Year: 2013

Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescriber decides that the benefit of rechallenge will outweigh its risk. When considering intentional rechallenge, one should take into account the benefit/risk balance of the suspected causative medication, and the benefit/risk balance of the best available alternative treatment or no treatment. Clinical knowledge is essential in benefit/risk assessment but there is currently no suitable tool to guide the decision on rechallenge. This article aims to propose points to consider in the creation of reaction-specific algorithms for risk assessment and management in the case of drug rechallenge. © 2013 Springer International Publishing Switzerland.


Prabhakar U.,NDA Regulatory Science Ltd | Edwards B.,NDA Regulatory Science Ltd
Pharmaceutical Medicine | Year: 2010

Management of spontaneous reports remains one of the most important activities in postmarketing surveillance. Increasingly, spontaneous reporting data are publically available, particularly following the criticism from the European Ombudsman over data secrecy by the European Medicines Agency in August this year. New legislation in the EU could mean the number of reports may well increase and so it is timely to reflect on what is best practice for spontaneous case management based on guidance from sources such as the Council for International Organization of Medical Sciences (CIOMS) V Working Group, combined with the latest thinking on systems science. Experience from implementing and maintaining systems in other safety conscious sectors has revealed the overriding importance of the 'human factor' in ensuring compliance and managing this through organizational learning, team-working principles and communication. Spontaneous data are very heterogeneous, and it is critical to understand the various types of adverse events and how they differ from adverse reactions. There is a paucity of published data about how to implement effective spontaneous reporting processes. Based on what we understand about quality systems, there needs to be a documented sequence of activities to manage the information, mitigate variation and manage errors and other process-related risks. Close attention needs to be paid to training employees around first interactions with a reporter, as this first step is the most important step in capturing all relevant facts regarding a report and determining subsequent case quality. However, success depends on an organizational structure with defined roles and responsibilities and optimization of personnel interaction ideally through a competency framework. Both quantitative and qualitative tools and metrics are needed to manage process quality, which can be useful for audit. Technology should be automated for efficiency and consistency without crushing ingenuity and innovation. Disappointingly, although companies describe how they have improved process effectiveness, there has been no public benchmarking to enable other companies to examine what works and what does not. This means we have to resort to the principles of quality management and organizational science and adapt them according to the needs of an organizations spontaneous reporting processes. © 2010 Adis Data Information BV. All rights reserved.


Edwards B.,NDA Regulatory Science Ltd | Kinsella N.,NDA Regulatory Science Ltd
Regulatory Rapporteur | Year: 2011

The need for risk management to underpin development of ATMPs has never been greater, because of the increased regulatory and societal scrutiny of such products. Pharmacovigilance and risk management have to be individually customised for each product so that useful information can be converted into usable data. This requires eff ective planning to ensure good quality processes are in place. Such processes will ease the preparation of a developmental risk management plan, which in turn will reassure regulators that a proactive approach to safety is underway.


PubMed | NDA Regulatory Science Ltd
Type: Journal Article | Journal: Drug safety | Year: 2012

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards Dear Healthcare Professional Communications, there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a companys risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are used globally, we are not aware of any research into their effectiveness outside the ICH regions. What listed companies can communicate about benefits and risks is strongly influenced by the obligations of companies to the market and investors. There needs to be internal coordination for simultaneous release. Internal communications about significant issues should be restricted to those who know how to manage the risk of insider dealing from internal communications that may later be made public. Unfortunately, there is evidence that some companies do not have a cohesive strategy for communicating risk which should take into account all forms of promotional material and company-sponsored information sources on the Internet. A pharmaceutical company is not the only stakeholder responsible for communicating risks on their products. However, the relative roles and responsibilities of all relevant stakeholders are not defined and are often unclear. This means it is difficult to evaluate whether a companys actions might be duplicative or inefficient. We recommend that companies have a dedicated communications group whose role is to coordinate the companys communications strategy mapped to objectives that have been agreed with key stakeholders apart from just regulatory agencies. This same group can assess effectiveness of the communications, monitor audience reaction and adjust the communication strategy accordingly.

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