Regulatory Intelligence Clinical Quality & Risk Management

Regulatory pressure is increasing and so is the output of new legislation. Some of the new regulations may have a major impact on your operations, while others have only a marginal one, and still others can be “ignored.” Therefore, it is critical that you and your company are made aware of changes that have an impact on your operations, and avoid changes being initiated or implemented when there is no real need for change.

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How can Widler & Schiemann assist you with your Regulatory Intelligence challenges?
Through their network Widler & Schiemann are uniquely placed to get an early insight into planned changes that may affect your operations. Even more importantly they are able to put these in the right legal and regulatory context to guide you in making the right process and organisational changes or to confidently refuse changes without incurring risk.

Widler & Schiemann will provide your experts and process owners with proactive alerts of regulatory changes and work with them to determine what the impact of these are on your processes and operations. If changes are warranted Widler & Schiemann are available to help you to determine the necessary changes and implement the right change management measures.

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Corporate Compliance

Compliance with rules outside the traditional GxP field such as compliance with advertising rules and payments to health care providers (HCP) are becoming increasingly important for companies.

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For instance, under the influence of the US Sunshine Act and similar legislation in other countries (e.g. Italy), strict rules about what can be legally paid to HCPs and how to document and report these payments must be implemented by all companies. Noncompliance with these rules can result in very expensive fines and even penal prosecution.

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How can Widler & Schiemann assist you with your Corporate Compliance priorities?
Widler & Schiemann have had, with their previous employers, central roles in defining the systems’ requirements, performing a risk analysis and defining and roll-out of processes for health care compliance. They were also key contributors to companies’ multi-faceted sustainability efforts and initiatives.

Widler & Schiemann will work with your management and experts to identify your obligations and requirements for a Corporate Compliance policy and approach, and design effective implementation plans.

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Inspection Readiness Support

The implementation of the EU Clinical Trials Directive has resulted in a dramatic increase in the number and scope of inspections in Europe. At the same time the US FDA has increased their inspection capacities. In addition, US FDA and EMA and relevant national inspectorates have increased their collaboration, settled on common inspection standards and formalised the exchange of inspection reports.

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In parallel, these agencies have engaged in global capability building and training programs that have resulted in the creation of national inspectorates in Asia, Latin America, Africa and the Middle East. The effects of these regulatory efforts are clear: the number of inspections is steadily increasing - year by year - and in a large multinational company can be as high as 40 – 50 inspections per year. Start-up companies should bear in mind that Health Authority inspections, especially in Europe, are not necessarily linked to a regulatory submission but can occur at any time and in any clinical trial of any phase.

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How can Widler & Schiemann assist you with the Inspection Readiness of your company?
Widler & Schiemann have a recognised track record of developing and implementing a process to make an organisation inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state, and a self-assessment tool provides objective evidence of strengths and weaknesses of the organisation in terms of inspection readiness.

Widler & Schiemann will work with your management, experts and process owners to identify inspection readiness gaps, define where necessary effective CAPA plans and oversee their timely implementation. In case of a Health Authority inspection Widler & Schiemann can be brought in as additional resources to support your organisation during the inspection and, if necessary, help with responses to the inspectors.

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Quality Management of Pharmacovigilance Processes

Robust data to support a thorough benefit - risk assessment is one of the most important deliverables when submitting your application for marketing approval or label extension.

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One main factor forming the basis of this is a sound reporting process for adverse events in your clinical studies. This becomes even more crucial when clinical studies are outsourced or when a group of investigators is the sponsor of your pivotal trial (IST – investigator sponsored trial). In addition, spontaneous cases have to be reported diligently to the Competent Authorities within stringent timelines. In the new EU pharmacovigilance legislation that has become effective 1st July 2012, there is an explicit call for an established and robust Quality System for the performance of pharmacovigilance activities to be implemented by the Agency (EMA), national competent authorities and marketing authorisation holders (Presentation/2011/06). This highlights the need for companies and other stakeholders to start now to build a robust QMS driving the pharmacovigilance processes.

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How can Widler & Schiemann assist you with your Pharmacovigilance projects?
Over the past 6 years Widler & Schiemann have established in their former company a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or from spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need. This QMS approach is also in line with the new EU pharmacovigilance legislation.

Widler & Schiemann will work with your experts and process owners in first analysing the current pharmacovigilance processes in your company to identifying any relevant deficiencies. By applying the QbD and QRM approaches the key process steps and related parameters will be identified and processes will be re-designed and implemented based on the first analysis.

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Independent QA Support & Services

Large and small organisations have recognised the need for a strong, competent and independent Quality Assurance function. It is not only because regulations such as ICH GCP call for an independent QA function, but more and more organisations have realised that sustainable quality, “right first time” and Quality by Design (QbD) approaches are essential elements for an efficient and effective business model.

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Operational Excellence as defined in 6-Sigma results in sustainable cost savings because avoidable process redundancies and product rework are avoided: while the cost of goods or services decreases, quality increases. Smaller organisations in particular, face a dilemma when planning to introduce a QbD or operational excellence approach: a strong QA function is needed but hiring a full-time QA person may not be financially justifiable. Finding skilled and experienced QA experts to take on a part-time role is almost always a “mission impossible,” or, if successful, saddles the organisation with high costs since such experts are rare and sought after by large and smaller enterprises. Hiring a more junior QA person will on the other hand not bring the required expertise nor bestow the QA function with the necessary authority. If in spite of all these odds when a suitable candidate is hired, retention becomes the next challenge.

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How can Widler & Schiemann assist you with your Quality Support priorities and needs?
Widler & Schiemann have a demonstrated track record of successful implementation of QA plans and strategies as well as CAPA programs and QA infrastructure and organisations. In the past they successfully coached experienced and junior colleagues in defining and leading straightforward and complex QA projects and activities. As a result of this support, teams and project responsibles proactively sought their advice and asked for the services of the CQA function.

Widler & Schiemann will work with your management to identify what the short-, mid- and long-term sourcing strategy for the QA function should optimally be, what is an optimal set-up for your QA function, and whether an in-sourced, an outsourced vs. mixed solution is more efficient and effective. If reliance on less experienced or part-time QA staff is determined to be the most effective approach, Widler & Schiemann can coach and train your staff at regular intervals, work with them to develop coherent and state-of-the-art QA plans and strategies and actively accompany them throughout the implementation and completion.

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