Blog about Pharmaceuticals – Medical devices – Clinical Trials and Health Care

16-Feb-2010

The study reveals that $14.3 billion dollars worth of counterfeit drugs are sold yearly within Europe with Germany and Italy representing the majority of consumers

The survey asked around 14,000 people in 14 European countries and showed a staggering 38 per cent rise in the number of individuals who confirmed that they did buy prescription drugs without a prescription in Germany and Italy, and only 21 per cent confirmed that in the other countries.

Jim Thomson, chair of the European Alliance for Access to Safe Medicines (EAASM), confirmed the report and told Reuters that:

“Counterfeit medicine is costing the industry a huge amount of money but it’s costing healthcare providers a lot more.”

Pfizer’s ran the research because it is highly affected by this problem with its products Viagra and Lipitor being the target of major fakers

Lowering the time and cost of computer system validation while ensuring FDA compliance -

Benefits from the Webinar:

• Discover how web-based applications reduce the burden of validation
• Understand how to significantly reduce costs while gaining and maintaining strict compliance with regulations: FDA 21 CFR Part 11, GCP, GMP and Sarbanes-Oxley
• Answer key questions on how the differences between thin and thick client based software can affect your business when designing, producing and managing compliant labels

Full Details….

7th October 2009 – is the anniversary of the first patent on the bar code. Inventors Norman Woodland and Bernard Silver filed the patent on October 1949, and it was granted #2,612,994 on October 7, 1952. The original patent was for a system that would encode data in circles (a bulls eye pattern), so that it could be scanned in any direction and was first created for use on train carriages.

In celebration, Google has replaced its homepage logo with a bar code. It is Code 128 encoded, which is a standard way of encoding ASCII character strings (i.e. A-Z, a-z, 0-9, etc.) into a barcode.

A traditional barcode is made up of a series of vertical bars of variable width that are scanned by a laser. This optical reader converts the information into a digital format which is then processed by a computer.

However, the Uniform Product code we use today to keep track of billions of items around the world, was invented by IBM engineer George Laurer in 1973.

The Centre for Business Intelligence’s 4th Clinical Supply Chain Management Conference taking place at the Hyatt Regency Princeton New Jersey today and tomorrow (30th and 31st July) will provide a forum for discussion on a variety of topics including labelling regulatory compliance, shipping requirements, and how to increase efficiency of labelling operations.

Bob Brunk, PrisymID’s West Coast US Sales Manager is travelling to New Jersey to deliver a presentation focusing on the use of a dedicated Label Management Systems such as Prisym Medica and Prisym Medica ClinTrial. Bob will describe how using a dedicated designed for purpose solution can improve the efficiency of any organisation looking to package and label clinical trial supplies and comply with regulations such as 21 CFR Part 11.

Prisym Medica and Prisym Medica ClinTrial enables many of the worlds largest Clinical Trials outsourcing companies to operate efficiently, and has helped many smaller organisations become more efficient and effective.

Bob will describe some of the advantages that Prisym Medica ClinTrial offers our customers.

• ACCURATE – Through automated version control and Approval Management
• PRECISE – Label designs are easy to create & approve
• COLLABORATIVE – Labels, and Trial Data are centralised and can be access wherever you need it
• FLEXIBLE – Trial data can be randomised or imported
• EFFICIENT – Labels generated at the touch of a button
• COMPLIANT – Everything is audited and secure to 21 CFR Part 11

The Pharmaceutical industry faces challenges in meeting the requirements for serialization coding, challenges
that PRISYMID has been addressing for almost two decades. Our proven, robust and extensively deployed
technology will meet your specific serialization requirements – no matter what manufacturing system, ERP
solution or printing and vision technology you use on your production lines.
‘PRISYM Medica for Oracle’ comprises a full suite of label and code printing applications based on the
Oracle Database and integration for connectivity to your current manufacturing and ERP system.

Serialisation
As new directives and regulations come into force to reduce reimbursement and counterfeit fraud it, is imperative that
organisations can adapt production processes swiftly and efficiently to comply with these regulations.
The latest addition to ‘PRISYM Medica for Oracle’ is the ‘Serialisation Link’ developed to meet the impending
serialisation legislation. Developed in collaboration with Oracle and specifically designed to create very high volumes
of unique, secured and ‘intelligent’ serial numbers. It provides serialised product for industry requirements such
as EFPIA and Turkey and could form the foundation of an ePedigree and EPCIS solution.

• Mass serialised number generation and management
• Serial number relationship and aggregation mapping
• Full cryptographic security
• Full Identity lifecycle Audit management

Get full details by checking this case study from Prisym Life Sciences website

As pressure from generics increases companies are starting to appreciate the value of brand loyalty.  There will always be some consumers that buy on price but for many a name you can trust is still important.  The focus on branding is impacting many of the labeling projects we are seeing.  A requirement for flexibility to include consistent branding elements on the secondary label is now common.   How this is managed across many different manufacturing, packaging and distribution sites is often the tricky bit.  This is where a web based system like PRISYM Medica comes into it’s own.  Imagine being able to share an approved label design with all your branding elements in place with any site in the world instantly within a compliant labeling system.  Only one design studio is necessary rather than label designers at every site.  This along with the lockable label formats in PRISYM means that the branding (along with all the vital, variable information) is easily controlled.

One thing pharma companies are not cutting back on right now is compliance and quality.  A recent survey by compliance specialist Sparta revealed that 80% of quality managers stated their budget had been excluded from cut backs.  Read the rest of this entry »

GS1 adoption is vital as life sciences and healthcare companies focus on reducing operating costs, increasing efficiency and improving patient safety.

Software companies are rising to the challenge as the life sciences and healthcare industries focus on reducing operating costs and increasing efficiency in these tough times.  Automating inventory management, labelling control and traceability are key areas in this quest.  But it all has to start with consistent identification standards. This effort is being under pinned by widespread adoption of the GS1 standards within these industries.  The news item below is yet another example of the backing that individual healthcare organisations are giving the GS1 standards.

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A recent European conference hosted by TOPRA, held to discuss the legislative changes outlined in the “Pharma Package” published by the European Commission on 10th December 2008 has outlined the deep penetration of counterfeit drugs within the pharmaceutical supply chain.

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