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Jan 27, 2015

Publication by the RbM Consortium
10 Burning Questions about Risk-based Study Management

The RbM Consortium is a transnational alliance of quality risk management industry experts, risk-based technology firms, data analysts, and biopharmaceutical business strategists. Members of this group include Widler & Schiemann AG, PPH plus, Cyntegrity, and Annex Clinical. The objective of this collaboration is to improve awareness of Risk-based Monitoring (RbM) in clinical trials, to advise biopharmaceutical enterprises, medical device companies, CROs, study sponsors, and study sites on best practices, and communicating the best implementation strategies on sound quality risk management systems, technologies and business methodologies in RbM. This guidance document will offer information about RbM strategies.

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Biggest Revision of International GCP since 1996!
The new ICH E6 (R2) Addendum: What does it mean?

Quoting from the ICH Business Plan: "Since the adoption of the ICH E6 Guideline on Good Clinical Practice (GCP), clinical trials have evolved substantially, with increases in globalisation, study complexity, and technological capabilities. To keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology [it is] propose[d] to modernise [the] approach to GCP to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. Although ICH E6 generally can be interpreted as providing sponsors flexibility to implement innovative approaches, it has been misinterpreted and implemented in ways that impede innovation by, for example, emphasising less important aspects of trials (e.g., focusing on the completeness and accuracy of every piece of data) at the expense of critical aspects (e.g., carefully managing risks to the integrity of key outcome data)." Beat Widler has submitted via EFGCP comments and specifically suggested to include a whole section about patients (beside the "traditional" sections about sponsors, IECs and investigators).

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The CenterWatch Monthly January 2015
All Eyes on EMAs adaptive Licensing Pilot - Beat Widler quoted!

"Acceptance from the public at large and the politicians is one of the biggest hurdles to overcome. If regulators approve a product and they have to pull it, which is inevitable, they will be accused of bending over backwards for big pharma," said Beat Widler, Ph.D., managing partner and co-founder of Widler & Schiemann, who worked at Roche for more than 25 years. "We have a risk adverse society. We enjoy the benefits. But if something goes wrong, we start pointing fingers."

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FDA's Holiday Gift to Industry: Easy-to-Search Guidance Documents
A unified, easy-to-view database of guidance documents

The new database serves as a vast improvement over FDA's previously fragmented lists of guidance documents, which were scattered throughout the agency's website and not always kept up-to-date.

In contrast, the new guidance database contains many guidance documents issued by all of FDA's various offices and centers, and is updated to clearly list all of the agency's most recent documents as well.

The system also contains a number of useful features. For example, regulatory professionals can search for guidance documents by product type (e.g. biologics or medical devices) or by FDA office (e.g. CBER, CDER, CDRH), allowing the user to quickly find relevant documents.

In addition, the database contains a search bar that automatically populates results as the user types a query, making it much easier to find a document without resorting to a time-consuming series of searches.

The database also contains useful information such as links to the FDA docket related to a guidance, whether there is an open comment period on the guidance, whether the guidance is in draft or final form, when it was issued, and which FDA centers have signed on to the guidance.

The database also seems to be configured to eventually include information from FDA's operation manuals, compliance policy guides, import alerts and more.

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ISO 9001:2015: Risk-based Thinking
One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to risk, rather than treating it as a single component of a quality management system

In previous editions of ISO 9001, a clause on preventive action was separated from the whole. Now risk is considered and included throughout the standard. By taking a risk-based approach, an organization becomes proactive rather than purely reactive, preventing or reducing undesired effects and promoting continual improvement. Preventive action is automatic when a management system is risk-based. Risk-based thinking is something we all do automatically and often sub-consciously.

The concept of risk has always been implicit in ISO 9001 - this revision makes it more explicit and builds it into the whole management system. The risk is considered from the beginning and throughout the standard, making preventive action part of strategic planning as well as operation and review. Risk-based thinking makes preventive action part of the routine. Risk is often thought of only in the negative sense. Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk. Opportunity is not always directly related to risk but it is always related to the objectives. By considering a situation it may be possible to identify opportunities to improve. It is necessary to analyze the opportunities and consider which can or should be acted on. Both the impact and the feasibility of taking an opportunity must be considered. Whatever action is taken will change the context and the risks and these must then be reconsidered.


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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -