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  • 22.09.2009, 09:00 Uhr
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  • München/Washington D.C
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  • 0 Kommentare
Interview with Ms.Vernette Molloy

Ms.Vernette Molloy: „cuts in staffing at the pharmaceutical companies benefit independent people consultants“

Vernette Molloy is a highly experienced, independent senior clinical research auditor with 16 years in the pharmaceutical industry. She owns her own business and audited for over 75 companies in pharma, biologics, devices, diagnostics, as well as for the Federal Government. Vernette Molloy is a registered nurse from Montgomery College, as well as a Master graduate in Business Administration from Frostburg State University. On the basis of her job, she travelled to Munich many times and talked with Nurcan Özdemir about the differences of America´s and Bavaria´s Capital. Ms. Molloy, what exactly is your job description?

Ms. Molloy: I am an independent clinical research auditor. I audit investigational clinical studies that are being conducted globally by pharmaceutical and biotechnology companies. I own my own business in the Washington D.C. Metro Area. What are your ties with Munich?

Ms. Molloy: I have been to Munich several times on behalf of pharmaceutical companies who were conducting studies at various investigational sites in Munich. What remarkable differences did you notice between Munich and Washington, D.C. in terms of the business?

Ms. Molloy: The investigators (physicians) in Munich are very welcoming and hospitable. They tend to perceive the audits as nothing to dread, but something to learn from. Their work is very organized with a good deal of attention paid on details....a must for clinical studies. There are differences in regulatory requirements between the US and the EU, but over the years with the globalization of requirements and standards for clinical studies in these two world arenas, the differences have become much smaller. How about the Health Care?

Ms. Molloy: There still are differences in the delivery of health care, such as registered nurses in the US have more autonomy, but the International Conference of Harmonization that originated in Europe has brought the standards for clinical research much closer together. In your opinion, does Munich (Germany) offer a better platform for the business or Washington (USA)?

Ms. Molloy: In general, I think they are both about equal, since they work hand in hand. How does the economical crisis effect the pharma business in both places?

Ms. Molloy: There have been many cuts in staffing at the companies, which actually does benefit me since the companies have looked to independent people consultants, such as myself, to conduct the audits. Bio-technology companies have suffered in particular because there has not been enough investor capital to subsidize their studies. This is a global problem because the US and the EU have partnered in many drug development endeavors. In addition, clinical studies over the past decade especially have tried to adhere to a globalization of standards for conducting clinical research. Therefore, the US and the EU are closely aligned in bringing new products to the global marketplace. How does the future of the business look like?

Ms. Molloy: The situation is improving already. And, with the new US administration, hopefully more money will be available for research purposes in both government and private sectors. This in turn should positively affect the research industry in the EU. How do you like Munich as a city?

Ms. Molloy: The people are very friendly and I love shopping there! I´m crazy about the Steiff bears and the wonderful breads. Ms.Molloy, thank you very much for the interview!

(Nurcan Özdemir)



Ms.Vernette Molloy

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