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Will ISO 27001 Become the National Information Security Standard?Authored by John DiMario, Certified Six Sigma BB, HISP
Many organizations are subject to a slew of laws and regulations aimed at information security such as Gramm-Leach-Bliley (privacy), HIPPA, Federal Financial Institutions Examination Council (authentication and online banking), and Payment Card Industry (card security). There also exists California's and other states' data breach disclosure laws, and the Sarbanes-Oxley Act, which requires IT to test the effectiveness of controls over financial-reporting systems, the European Union's privacy laws, etc. While these laws and regulations do a good job of defining the scope of information security and spelling out the role of information security in risk management, they have little to say about what constitutes effective information security or how to achieve it.
ISO 27001 does precisely that. By adhering to this standard, your organization can go a long way towards satisfying regulatory compliance requirements. Click here to read more.
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Noncompliant Promotional Practices Cost Pfizer $2.3 BillionAuthored by David Tribbett, Compliance Advisor
Pharmaceutical giant Pfizer will pay $2.3 billion in the largest health care fraud settlement in history. The settlement with the U.S. Department of Justice resolves criminal and civil allegations that the company used illegal tactics to promote several of its drugs, most notably the painkiller Bextra. Additionally, as part of the agreement, the Department of Health and Human Services will monitor Pfizer's marketing more closely over the next five years. That agreement, according to the FBI, provides "for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter."
The settlement also covers Pfizer's promotions of epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Authorities called Pfizer a repeat offender, saying it is the company's fourth settlement of government charges in the last decade.
Click here to read more. |
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Ping Poulsen Attends Taiwan Conference At the invitation of the Taiwan Ministry of Economic Affairs, Ping Poulsen attended the 2009 Taiwan Business Alliance Conference. The conference was held Oct 7-8, 2009 at the Taipei International Convention Center. The conference was organized by the Ministry of Economic Affairs (MOEA) and co-organized by the Taiwan External Trade Development Council (TAITRA). The conference focused on four industries: green industry, auto electronics, tourism and recreation, and healthcare. Included in the conference were presentations on investing in Taiwan and panel discussions focused on each of the industries. The second day of the conference included tours of facilities related to each industry. The healthcare track included tours of Industrial Technology Research Institute (ITRI), a national research organization, and Adimmune Corporation, the only human vaccine manufacturer in Taiwan.
While in Taiwan, Poulsen also visited several pharmaceutical, biotech, and medical device companies. The Indiana Economic Development Corporation aided Poulsen in arranging these meetings.
The Taiwanese government has budgeted NT$86.4 billion (2.6 billion U.S. dollars) toward the development of the domestic healthcare industry. This four-year investment program is aimed at boosting industry revenue by NT$346.4 billion and adding 310,000 jobs by 2012. Taiwan's internationally acclaimed healthcare system provides easy access to medical treatment with costs that are relatively low compared to Europe, America and Japan. Visit the website for more information on the conference and recent changes aimed at easing travel and investment opportunities in Taiwan.
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Safis Welcomes New Member to Our Team
Safis is proud to announce the addition of W. Shawn Conway to our Sales and Business Development Team. Conway is an accomplished business development leader with extensive expertise in business and organizational development strategies, execution, and executive-level relationship management. He brings broad experience to the position having worked in both the Life Sciences industry - where he worked for companies such as Allergan, Inc., GE Medical Systems, and Picker International - and in the Commercial Real Estate industry - where he has represented several top Central Indiana Life Sciences companies. An active leader in professional associations, Conway is a Member of the Indiana Leadership Forum, the University of Minnesota Alumni Association, and former President of the Indiana CCIM Chapter. A contributor to the community, Conway consistently lends his time and talents to various not-for-profit organizations assisting in leadership, fundraising and teaching, and has founded a 501(c)(3) entity. Conway earned a Certified Commercial Investment Member (CCIM) Professional Commercial Real Estate Designation from the CCIM Institute. He earned an M.A. in Business Administration from Webster University, while serving as a Regular Commissioned Officer in the United States Marine Corps. Conway has an undergraduate B.A. in Sociology from the University of Minnesota.
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Upcoming Events
2009 Fourth Quarter Events
November 2-3 The Regulatory Affairs Professional Society presents Regulatory Strategy Forum for Pharmaceuticals in Raleigh, NC.
November 10 The Indiana Biomedical Entrepreneur Network holds a monthly meeting at the IUETC in Indianapolis, IN, on the topic of "Building an A+ management Team" See Website
November 13, Indiana Life Sciences Collaboration Series presents Comparative Effectiveness: the Dollars and Sense Overview. See website
December
December 3 ASQ Biomedical Division Midwest Discussion Group features James Utterback who will be speaking on "FDA Inspection Readiness". Contact Scott Willis at: Scott.Willis@telamon-corp.com.
December 9 Life Science Alley Conference in Minneapolis MN. See Website. Shawn Conway will be attending.
Other Midwest Monthly/Quarterly Events
ASQ Biomedical Division Midwest Discussion Group
For more information about chapter events, please, contact Scott Willis at: Scott.Willis@telamon-corp.com.
IHIF Lunch Conference Series
Meetings are held the third Tuesday of every month from 11:30 - 1:00 PM. For more information, go to: www.ihif.org/pages/lifescience.
Indiana Life Sciences Project Management Group
Information regarding monthly meetings is listed at:
INpact Medical Device Network
Meetings are held in Indianapolis, IN every third Friday of the month at 11am at Bingham and McHale. For more information, visit: www.inpact.org.
PDA Midwest Chapter
Information about monthly meetings held in Northbrook, Il, and Indianapolis, IN, is listed at: www.pdamidwest.org. |
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Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device, and biotech companies worldwide, to ensure health authority requirements are met. Areas of expertise include: regulatory approval, clinical strategies, quality systems, validation, IT services, auditing, and post-market surveillance programs. Let Safis Solutions help you excel in today's complex regulatory compliance environment.
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In This Issue
Will ISO 27001 Become the National Information Security Standard?Noncompliant Promotional Practices Cost Pfizer $2.3 Billion
Ping Poulsen Attends Taiwan Conference
Safis Welcomes New Member
2009 Fourth Quarter Events
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Eric English has more than 7 years of Quality Assurance experience within the pharmaceutical and biotechnology industries. He spent five years directly supporting contract testing and pre-IND and Phase I mammalian cell culture and protein purification, cell therapy, and cell banking manufacturing operations. He also has extensive experience in manufacturing operations and quality processes. English's specific areas of expertise include vendor qualification and management, GXP compliance auditing, development and implementation of quality systems, and GXP supply chain management processes.
English holds a Bachelor's degree in Chemistry from Haverford College in Philadelphia, PA. |
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John Lockwood, Senior Compliance Advisor, successfully completed the Canadian Medical Devices Conformity Assessment System examination. (CMDCAS) . |
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How can our newsletters better serve your needs? Please e-mail
Shawn Conway at sconway@safis-solutions.com or call 317-777-6200 ext. 110 with your thoughts.
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