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April 5, 2005  
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Compliance Column




Twice a month, the P.I.L.S. Compliance Columnist, Fiona Jones, explores the complex issues and strategies driving global compliance in all areas of the pharmaceutical industry.

P.I.L.S. Compliance Column:

To view the 2004 Compliance Column Archives, click here.

November 7, 2005

The controversial form of medicinal product promotion known as direct-to-consumer (DTC) advertising is back in the headlines.  This edition of the P.I.L.S. Compliance Column reviews feedback from the FDA public hearing debating the direct promotion of medical products to the consumer.

 ...full story

October 20, 2005

Bird flu was first identified over 100 years ago so why are scientists suddenly in a panic to find a vaccine to prevent a global pandemic?

 ...full story

October 5, 2005

One year after an FDA alert linking antidepressant use in children with increased suicidal thoughts we have another advisory raising concern that a popular ADHD medication may cause the same problems.

 ...full story

September 21, 2005

Pharmaceutical companies use open-label extension studies to provide important safety and tolerability data of unapproved drugs in long term, day to day “real-world” use.  However, ethicists are becoming increasingly concerned that these studies are being misused as a marketing tool to increase the number of people taking the drug before general release and therefore creating a market for the product.

 ...full story

September 9, 2005

Would you give your child a drug that hadn’t been clinical tested and approved for use? Well, you probably have and didn’t even realize it. It may surprise you to know that most drugs routinely given to anyone under the age of 18 have never actually been tested on children. This edition of the P.I.L.S. Compliance Column examines the latest move by the European Parliament to adopt Community legislation on medicinal products for children's use.

 ...full story

August 26, 2005

Following the old adage "If it's not broken don't fix it" is not always the best course of action. Molecular and computer scientists have presented clinicians with an impressive new toolbox that use appropriately could change the way clinical trials are conducted and managed resulting in more effective and targeted products. The clinical trial system is not broken but there is plenty of scope for updating and improving –- and the National Cancer Institute has a plan to do just that.

 ...full story

August 10, 2005

Advertising prescription products directly to the consumer is a controversial method of product promotion. To help counter criticism of the process, the pharmaceutical industry has just revealed a plan to self-police the practice. This edition of the P.I.L.S. Compliance Column examines this new Pharmaceutical Research and Manufacturers of America guidance on advertising medicines directly to the consumer.

 ...full story

July 12, 2005

In the world of drug testing we can’t afford to make mistakes -- or can we? This issue of the P.I.L.S. Compliance Column considers the idea that perhaps it’s better to be a failure than a success.  ...full story

June 28, 2005

Medical marijuana has a long history.  It may be used under medical supervision to help patients suffering from AIDS, cancer, chronic pain, multiple sclerosis and a host of other conditions.  The therapeutic benefits of marijuana appear to be well-documented and commonly accepted but the drug is illegal.  This issue of the P.I.L.S. Compliance Column considers some of the issues that are clouding the debate surrounding the legalization of medical marijuana.

 ...full story

June 9, 2005

This edition of the P.I.L.S. Compliance Column considers whether the European pharmaceutical sector, once the bastion of innovation, is falling behind the United States.  Compliance Columnist, Fiona Jones, brings her unique experience of working in the UK, France and the United States, to stimulate debate on this question.

 ...full story

May 26, 2005

This edition of the P.I.L.S. Compliance Column takes a look at some of the latest news items concerning the pharmaceutical industry and wonders whether all publicity really is good publicity?  ...full story

May 10, 2005

This week the World Health Organization announced the latest tool aimed at clamping down on drug counterfeiters. The communication system known as Rapid Alert System (RAS) will disseminate reports on the distribution of counterfeit medicine to the relevant authorities enabling them to take rapid and appropriate countermeasures. This edition of the P.I.L.S. Compliance Column takes a look at the problem of phony pharmaceuticals in the marketplace.

 ...full story

April 28, 2005

Many will be familiar with Braille text which is formed by a combination of 6 dots in relief in a 2 by 3 matrix but did you know it will soon be appearing on medicine labels across Europe?  The European Commission has issued a new requirement for labeling medicines in Braille, and for the provision of patient information leaflets in formats suitable for the blind and partially sighted. This edition of the P.I.L.S. Compliance Column examines some of the implications of this directive for  ...full story

April 13, 2005

Global sales of Cox-2 inhibitor drugs accounted for approximately $6 billion in 2004 but the past 7 months has seen two of the three FDA-approved drugs, pulled from the market.  This edition of the P.I.L.S. Compliance Column examines the FDA’s latest decision to withdraw the Pfizer arthritis drug BEXTRA® and considers some of the options available to patients.

 ...full story

March 17, 2005

This edition of the P.I.L.S. Compliance Column examines the latest controversy surrounding Irish pharmaceutical company Elan. The company had hoped that the days of angry investors, law suits, SEC investigations and a plummeting share price were behind it, but perhaps the luck o’ the Irish has finally run out.

 ...full story

March 4, 2005

This edition of the P.I.L.S. Compliance Column examines the latest controversy surrounding the treatment of attention deficit hyperactivity disorder and the different response taken by Health Canada and the FDA on the drug ADDERALL.  ...full story

February 22, 2005

The second part of this special two-part edition of the P.I.L.S. Compliance Column examines some of the myths surrounding dietary supplements and takes a look at some of the complex and confusing advertising standards that exist.

 ...full story

February 15, 2005

Looking for products to combat cancer, relieve depression and anxiety, cure impotence, fight obesity, give relief from symptoms of the menopause, fight fatigue, cure digestive problems, lower high blood pressure, help with prostate problems and prevent heart disease?  Just pop in to your local health food store!

The dietary supplement industry has experienced explosive growth and the pharmaceutical industry is eager to get in on the act  ...full story

January 26, 2005

Compliance with HIPAA requirements requires vast resources, time, and patience but HIPAA is here and it is law. To fully benefit from the impact of HIPAA, one must not view it as purely a compliance project but rather as a way to improve operations. Only by developing this approach, will HIPAA benefit those who it is meant to protect and provide the privacy that it promises.

 ...full story

January 13, 2005

Many of us will have made a resolution to lose weight this year. For most that will simply mean a few adjustments in our eating habits and perhaps a weekly trip to the local fitness center. However, for the 1 in 5 Americans classified as clinical obese, more drastic measures are sometimes necessary to lose weight.  ...full story
Fiona Jones -- Biography:

Fiona Jones graduated from the University of Aston in Birmingham, England with a degree in Pharmacology and Biochemistry. She began her career with a 3-year hands-on stint working in the biochemistry laboratories of the British National Health Service (NHS) in Birmingham and London.

Friendly colleagues suggested that she might be better suited to a desk-based job when she kept correcting their reports and rewriting the procedure books. Heeding this advice, she joined the Regulatory Affairs Department of SmithKline Beecham (now GlaxoSmithKline) in Weybridge, Surrey and her writing career was launched.

Ms. Jones gained first-hand knowledge of the regulatory data she had prepared when she became a Clinical Research Associate for the company. This career transition has given Fiona a broad understanding of the entire clinical trial process, with a unique perspective on the complexities of regulatory compliance.

In 1994, Fiona realized the potential for balancing work and leisure time and started a freelance-medical-writing business. Although initially based in England, the beauty of the French countryside beckoned and in 1996, Ms. Jones (and her freelance writing) moved to Burgundy. The travel-bug got the better of Fiona again in 2000 when she crossed the Atlantic and settled in New Jersey, U.S. Samples of Ms. Jones’s writing is available on her website at http://www.fipacian.com/published_works.htm.

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