Welcome to the PRISYM ID blog spot An Apple a Day, this is where our life sciences team share some of the interesting issues they come across in their work with some of the largest medical device, drug manufacturing and clinical trials companies all over the world. The blog has life sciences news, medical devices events, and pharmaceutical articles.
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The following post is a transcript of the Q&A session held recently at the labeling seminar we hosted in Philidelphia on 20th February 2009. It’s a frank discussion between representatives from leading pharmaceutical companies and myself, Product Manager for PRISYM ID.
The topics covered include the following and focus around our web-based labeling product Prisym MedicaWeb:
Thick and thin clients for labeling solutions
How a web-based solution can augment an existing package
Client and server based printing
Software version control
Capturing customer label approvals through web-based software
As part of the ‘GS1 Standards for Healthcare Working Group’ we are encouraged to see so many of the top US healthcare providers supporting adoption dates for the GS1 standards and proactively endorsing the standards to their suppliers.
Join myself and Martyn Kerluk on 20th February 2009 at 8.30am EST for a webinar on web-based labeling and surrounding FDA compliance issues. Experience the benefits of web-based labeling through a demo of Prisym Medica Web.
On the back of Pharma Packaging and Labeling 2009 we will be hosting a free seminar in Philadelphia and due to popular demand we’ll now be broadcasting this as a webinar too.
Click the link for the full event programme and to register:
There has been an increase in seminars, news articles and general comment on joint FDA and EMEA (European Medicines Agency) inspections recently. It seems a day doesn’t go by that a guide or webinar invitation doesn’t pop up in my email. Is it all as scary as it seems? And how does it affect labelling systems?
An advert by Pfizer, supported by the Medicines and Healthcare Regulatory Authority and other pharmaceutical and patient organisations dramatically shows the dangers of buying counterfeit drugs online:
The advert, showing a man coughing up a dead rat, will be shown across 600 cinemas in the UK and online.
David Gillen, medical director at Pfizer said, “the time has definitely come to issue a clear, unified message to people about the dangers of purchasing medicines from illicit and unregulated sources.”
“This advertising campaign forms part of a wider public education campaign launched by Pfizer last year to ensure the public is aware of the health risks they are taking by buying and consuming counterfeit medicines, potentially without even a proper diagnosis from a qualified healthcare professional,” he added.
Anti counterfeiting is a hot issue and many labelling and packaging managers are facing a big challenge in this area. The question is what is the best approach to tackling this issue? Item level serialisation and 2D or Data Matrix bar coding have been favoured by many.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has been calling for “the implementation of a standardized identification solution for pharmaceutical products across Europe. This solution is a unique bar code (Data Matrix) supported by a pan-European verification system enabling pharmacists to check each medicine pack before dispensing it to the patient.”
If you are responsible for your company’s labeling system compliance with FDA 21 CFR Part 11, you would have been interested in the recent presentation PRISYM ID made at the Institute of Validation’s week long conference in Philidelphia. Our presentation ‘Are you really 21 CFR Part 11 Compliant – A DIY Audit’ highlighted the some top areas for non compliance and our own experience of solutions to these issues.
Read on to find out what these areas are and how we’ve overcome them.
The twelfth edition of the GS1 Healthcare newsletter has been released, with a special feature on the PrisymID Life Sciences blog! To access the GS1Healthcare newsletter click the GS1 Website link in our ‘Useful Links’ section to the right or click the hyperlink above.
News from around the world:
Amerinet and Premier endorse GS1 Standards
Implementation of California pedigree law delayed until Jan 2015
Coding for Success in the UK
Early lessons learned from BRIDGE Pharma Traceability Pilot
GHX to become GDSN-certified data pool to accelerate use of GS1 Standards in Healthcare
20 years of bar coding experience at Smiths Medical
Anti-Counterfeiting Strategy at Sanofi-Aventis
GS1 Healthcare Update:
Advocating adoption of GS1 Standards in Healthcare in Maghreb countries
GS1 Healthcare Spain and FENIN to collaborate on GS1 Standards implementation
GS1 Healthcare US develops Healthcare provider tool kit
I have just returned from the very interesting Pharma Packaging and Labelling conference in Barcelona. While talking to many of the other delegates it was apparent that many drugs and medical device manufacturers have long and complicated processes for label management. Internal approval of label revisions or new designs could take weeks and in some cases months!
The difficulty being the sheer number of people in disparate locations that need to have input to label design and content from marketing and product development to legal and production managers. It’s not a problem our customers have as our software provides excellent approvals routing within the system and enables approved label designs to be locked and linked to approved databases.
You can find out more about Prisym Medica on our website. Of course there were many other issues raised throughout the conference particularly around anti counterfeiting, the importance of good design and patient compliance.
I presented on how key industry trends and legislation is impacting labelling management and control and highlighted how technology was helping with these challenges:
Dave Taylor - Pharma Packaging and Labelling Conference
GS1 barcode standards have been implemented into our core software but until very recently none of our life sciences customers have asked us if our solutions are GS1 compliant. I was wondering how important adopting the GS1 standards is to medical device and drug manufacturing companies. Is this something any of you are looking at right now or have you already implemented GS1?
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