MeDRA (Medical Dictionary for Regulatory Activities) is an internationally used medical dictionary developed by the ICH in the 1990s which will be widely utilized during pharmaceutical regulatory processes. One of its scopes of use is the data coding of adverse events and adverse reactions. MedRA has been translated into English, Japanese, Czech, Dutch, French, German, Hungarian, Italian, Portuguese and Spanish.
The great advantage of MedDRA is that it organises adverse events reported by clinical investigators into a standard format, making it possible to discover groups and relationships between cases that seem unique at first. This can be used for statistical reporting purposes during the creation of tables and listings. MedRA is structured into various hierarchical groups, arranged from very specific to very general. Based on its hierarcy, a specific event is listed under various connecting groups. The hierarchical groups are as follows:
Among the groups, SOC (System Organ Classes) includes the most general terms, while LLT (Lowest Level Terms) describe fully specific events. Beyond the scope of a given analysis, MedRA has contributed to the standardization of medical databases and hence to a better assessment of diseases.
Medication errors are the most common preventable cause of undesired adverse events in medication practice and present a major public health burden.
EU legislation requires information on medication errors to be collected and reported through national pharmacovigilance systems for evaluation and assessment.
Use of common definitions and collaboration with patient safety organisations underpin error prevention through the product life-cycle.
Read the full article here: Politopedia
Chris Anderson wrote the following interesting article about why your company needs an ISO 9001 certification:
When we talk about helping companies obtain ISO 9001:2015 certification, people often ask us, “Why does our company need to be ISO 9001 certified?” Good question. ISO 9001 is the quality management system (QMS) standard and it produces numerous benefits for any company willing to go that route. So, why should your organization obtain ISO 9001 certification?
ISO 9001 Certification
Becoming ISO 9001 certified means to pass a physical ISO 9001:2015 certification audit by a registrar (a certifying agency).
What Can You Do With This Certification?
You can use the fact that your company is ISO 9001:2015 certified in your marketing. Your management system and its processes have been certified to ISO 9001 so you do want to talk about your successful registration to ISO 9001 just as long as you do not suggest that your products are certified or that you are certified by ISO, which is what ISO certified implies.
What can’t you do?
- You can’t use or modify ISO’s logo…it is ISO’s brand and intellectual property.
- You can’t say ISO 9001 or ISO certified…You must spell it out. We are ISO 9001:2013 certified; we are not certified by ISO or by ISO 9001.
- ISO 9001:2015 cannot be listed on your products or used in literature to imply product certification…It’s not a product certification it’s a company certification.
- You must be careful with your scope description so it properly depicts your certified activities and geographic locations. For Bizmanualz it includes our manual products, training and consulting services from our St. Louis location.
To learn more about improving your processes, attend the latest Internal Auditor Class coming to our St. Louis, Missouri, lean ISO consulting offices. Download Free Sample ISO Procedure Templates to see how easy it is to use MW Word Templates to build your ISO Quality Management System.
The 10 reasons the article covers are the following:
Meet Customer Requirements
Get More Revenue and Business from New Customers
Improve Company and Product Quality
Increase Customer Satisfaction with your Products
Describe, Understand, and Communicate Your Company Processes
Develop a Professional Culture and Better Employee Morale
Improve the Consistency of Your Operations
Focus Management and Employees
Improve Efficiency, Reduce Waste, and Save Money
Achieve International Quality Recognition
See the original article here: Bizmanuals
The changes made during the ISO9001:2015 revision are considerably more substantial than those produced during the 2008 revision.
The article covers the following topics:
The standard is rewritten according to the HLS (High Level Structure)
Risk management becomes a foundation of the standard
A standard purposely open to the service industry
No more quality manual?!
Importance given to the context surrounding the certified organization and to its stakeholders
Knowledge is a resource like any other
Below is a short summary of the first topic. For the whole article please visit the source: http://www.isorevisions.com/iso-90012015-what-are-the-main-changes/
The ISO 9001:2015 standard has been restructured: chapter and subchapter titles, as well as the order of clauses and paragraphs, were completely revised.
Overall, this restructuring does not affect the standard’s content or requirements. When examining the text in detail, however, the structure has changed to comply with new composition guidelines and topic sequences.
This change reflects a strategic choice that will gradually be applied all ISO standards of management system. Initiated on ISO 55001 (Asset Management System), the new structure is consistent with Appendix SL to the ISO Directives, Part I.
With this new common structure, ISO aims to help businesses and organizations more easily integrate all or parts of their various management systems and ultimately achieve a truly unified management system.
This consistent common structure makes it easier for companies to include components of other standards that it deems relevant: parts of the environmental standard ISO 14001:2015, the asset management standard ISO 55001 and even the future ISO 45001 standard on occupational health and safety management.
The European Medicines Agency published it’s first issue of QPPV Update.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
The issue provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance.
Main content of it covers news regarding these topics, and what does it mean to you as someone working in Pharmacovigilance:
- “Pharmacovigilance in the product lifecycle” including: Risk Management Planning critical for patient safety and product innovation, Companies encouraged to seek scientific ad-vice for PASS, Initiative on Patient Registries.
- “Pharmacovigilance Pro-cesses” including topics such as: Quicker product information updates, Medical literature monitoring, Reliance on Article 57 data, Joint PRAC/CHMP assessment reports, Measuring the impact of pharmacovigilance activities.
- Pharmacovigilance guidance: a table that represents the latest adopted, planned, and under development guidance.
- “Pharmacovigilance IT Systems” covering: Article 57 database, EudraVigilance Auditable Requirements, PSUR Repository, Pharmacovigilance Fees.
- Pharmacovigilance dialogue about upcoming EMA events.
Download the issue here: EMA Site