International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries

Research and Markets has announced the addition of John Wiley and Sons Ltd’s new report International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries to their offering.

After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master’s degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.

This book will enable the user to understand the process of validation, how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

- Quality standards
- Regulatory requirements for IT systems
- Quality Management Systems-QMS
- Organization for an IT system
- Legal implications of an IT system
- Advanced quality management systems
- Validation process and validation techniques
- Validation of IT systems
- Risk assessment and risk management
- Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.
For more information visit Research and Markets

Source: John Wiley and Sons Ltd
Business Wire 
Source: Pharmiweb.com

New pharmacovigilance legislation comes into operation

Better protection of public health through strengthened EU system for medicines safety

02/07/2012 - The European Medicines Agency (EMA) welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

“The progress made in healthcare would not have been possible without medicines and the research and development community behind them. But we need smart regulation for the system to be able to continue to deliver safe and effective medicines,” said the Agency’s Executive Director, Guido Rasi.

“The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.”

The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010. Highlights of the new legislation include:

• establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC);
• clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making;
• engagement of patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events;
• improved collection of key information on medicines, e.g. through risk-proportionate, mandatory post-authorisation safety and efficacy studies;
• more transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.

The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.

Information about the roles and the functioning of the PRAC has been published today and can be found on the Agency’s website, together with more information about the new pharmacovigilance legislation.

Notes
1. This press release, together with all related documents, is available on the Agency’s website.
2. More information on the new pharmacovigilance legislation is available here.
3. The status report ‘Countdown to July 2012: the Establishment and Functioning of the PRAC’ is available on the Agency’s website.
4. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010.
5. More information on the work of the European Medicines Agency can be found on its website

And the winner is….

It seems The Stinging Nettle totally honored its name. I was amazed at the number of aggressive, sometimes even insulting comments and e-mails we’ve been receiving since the beginning of this action – it’s just fascinating how many people felt personally attacked. Anyway – here’s the promised result ;)

Whoever works in the medical translation field should be aware of the numerous existing standards (DIN/EN/ISO…) in this industry. Often, these standards even state the exact wording of entire segments. We’ve been so far expecting from translators to be able to identify whether a piece of text is subject to a certain standard (or could be) and accordingly conduct a search or contact us and simply ask. In this specific case, the relevant standards to use were DIN EN 980:2008-08 “Symbols for use in the labeling of medical devices; German version” and the draft standard DIN 6877-1:2007-12 “Magnetic resonance equipment for human use – Part 1: Instructions for labeling items within the controlled area”.

“Keller”, though not specialized in medical device texts, submitted a translation that was the closest in line with the rules of these standards and therefore earns the 50€. “S.W” (who’s no medical translator either) and “AL” did realize that those were texts that were probably set in standards but unfortunately did not submit any proposal.  I found “Michael’s” proposal very interesting as well – he is not a translator but his translation was qualitatively not different from many proposals.

You can read all proposals here and here

What did we learn?

None of the translators who participated knew the standards. Some found them as they were researching and translated correctly but most would probably have made a “wrong” translation of the segments. It occurred to us that during our time as freelancers, no agency ever said to us that a given part of the text was subject to a given standard nor ever provided us with these standard existing translations available (though this does not completely apply for pharmaceutical texts as some agencies take the time and provide their translators with all standards). We came therefore to the decision that, in the future, we will be informing our translators when we give them a new project where standards apply and make those standards available to them.

I would like to thank all translators who participated. It was an interesting experience and we did learn something. We hope that translators in the future will also pay more attention to regulatory requirements in the medical technology field, and keep themselves up-to-date with these as well.
The next “translation survey” is already in the oven and we’d be delighted if you decide to participate again, or participate for the first time!