Managing cGMP Spawns Other Efforts for One Pharma

Marketers Need Metrics, Secure Communications Tools

New Pharma-IT Products

   Thursday, Jan 27, 2005 Archives Bio-IT World News Bulletin Subscribe Advertising
 
 
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Managing cGMP Spawns Other Efforts for One Pharma

Albany Molecular Research Inc. recently shifted the management of its compliance-related, current good manufacturing practices (cGMP) standard operating procedure documents from a 100 percent paper-based system to an electronic quality and compliance management system from MetricStream. While the move was undertaken specifically for cGMP, the company soon realized the system could help administer documents related to other compliance efforts, including the FDA's Corrective Action and Prevention Action program.


"SOP management drove us to get a [compliant management] system in place," says Ashley Peacock, validation manager at Albany Molecular, a chemistry-based drug discovery and development company. "We just knew we had to move to something electronic."

    Read More . . . 

Marketers Need Metrics, Secure Communications Tools

A new survey finds that pharmaceutical manufacturers overwhelmingly agree that marketing programs in 2005 will increasingly focus on patient programs, including e-marketing initiatives and programs that target patients while they are in a doctor's office.


The direct-to-consumer (DTC) marketing survey was conducted in October by Optas Inc., which provides software and services that allow pharmaceutical companies to launch and manage DTC marketing projects, and by DTC Perspectives Inc., a publishing, conferences/training, and consulting company specializing in consumer marketing of pharmaceuticals.

    Read More . . . 

Featured Events

2005 Pharmaceutical Marketing Compliance Congress - January 31 - February 1, Washington, DC

Compliance in Life Science Manufacturing - February 7-8, Baltimore, MD

Clinical Trials Congress - February 23-25, Loews Hotel, Philadelphia, PA 

Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA

IBC's 9th Annual Conference, InfoTechPharma - 15-16 March, Novotel London West, UK

Pharmatechnology Congress - March 14-16, Loews Hotel, Philadelphia, PA

Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA

IT Solutions for Drug Discovery at Bio-IT World Conference + Expo - May 17-19, Boston, MA

Best Practices Awards - Call for Entries - Early Bird Deadline, January 30

Would you like to see your conference or event listed here? Contact Shari Redan at shari_redan@bio-itworld.com for more information.



New Pharma-IT Products

Siebel Systems announced Siebel CRM OnDemand Release 6, an upgrade to its IBM-hosted CRM offering with life science-specific features and more reporting and analytic tools...

Oracle released a version of its 10g database software optimized for mobile application development and deployment...

Optas Inc. announced Optas 5.4, relationship marketing management software that helps pharmaceutical companies automate and develop targeted communications with their patients, physicians, and partners.

    Read More . . . 


Links to Related Stories 

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International Alliance of Pharmaceutical Associations Agree on Principles for Disclosing Information


Prune IT Systems, Not Budgets


Sun Announces Java RFID Product, Architectures


IBM Seeks to SCORE with New Compliance Suite



Featured Events

Upcoming Industry Events

2005 Pharmaceutical Marketing Compliance Congress - January 31 - February 1, Washington, D.C.
The 2005 event reconvenes over 350 high level legal, compliance and regulatory members of the pharmaceutical industry and features tracks on direct-to-consumer advertising, off-label promotion and fraud & abuse.For more information or to register, please contact the Center for Business Intelligence
 http://www.marketingcompliance.com, or call toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com

Compliance in Life Science Manufacturing - February 7-8, Baltimore, MD
Feature presenters from leading pharmaceutical companies across the USA and will focus on ensuring comprehensive compliance from facility design through to manufacturing processes. For more information please visit -
 www.marcusevansbb.com/compliance1

Clinical Trials Congress - February 23-25, Loews Hotel, Philadelphia, PA
The 2005 Clinical Trials Congress provides attendees with case study examples of clinical process optimization, the latest tools and technologies to increase efficiency and to maximize their clinical ROI.  With the highly-anticipated FDA Critical Path Initiative being released by the end of 2004, CTC is proud to have Dr. Janet Woodcock, the Director of Center for Drug Evaluation and Research at the FDA discuss the details of this Initiative and its effects on clinical trials. CTC provides numerous panel discussions, roundtables, networking receptions and interactive sessions. Visit 
 www.clinicalevent.com

Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA
http://www.cbinet.com/events/HB517/index.html 
Attend CBI's Leverage Natural Products for Drug Development conference, February 28 - March 1, 2005 in Philadelphia, PA to better understand the value of natural products in the drug development process and methods for harnessing the opportunity they present. Special team discount rates are available. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at
 cbireg@cbinet.com

IBC's 9th Annual Conference, InfoTechPharma - 15 - 16 March, Novotel London West, UK
The premier annual global forum for top-level Pharma IT executives, examining innovative IT systems and applications to support and accelerate R&D. The format of this year's conference will provide an environment that will facilitate interactivity and encourage constructive dialogue. Senior level industry experts will act as a catalyst for thought provoking group discussions. For further details or to register, please visit:
 http://www.infotechpharma.com/default.asp?src=bioit

Pharmatechnology Congress - March 14-16, Loews Hotel, Philadelphia, PA
Pharmaceutical Technology Congress is the best-in-class meeting place for HOW pharma and biotech manages information and implements technology/IT strategy across the value chain for BOTTOM-LINE DRIVEN RESULTS.Presentations include a focus on: industry best practices, comparisons of pharma company Key Performance Indicators, Case Studies on Technology ROI and sessions on Business Process Management within R & D, Clinical Development, Sales and Marketing and Supply Chain. Visit us at
 www.pharmatechcongress.com

Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA.
This event Features programs on Bioinformatics, RNA Interference, Proteomics, Systems Biologym, and new to 2005 Genomic Variation. We anticipate more than 1,000 scientists and over 40 exhibiting companies. visit
 www.beyondgenome.com for more information.

IT SOLUTIONS FOR DRUG DISCOVERY CONFERENCE PROGRAM - featured at Bio-IT World Conference + Expo, May 17-19, Boston, MA
Register by April 1 with Priority Code: B0203 and SAVE!
http://www.bio-itworldexpo.com/live/26/events/26BOS05A/conference/CC881012
IT Solutions for Drug Discovery, a specialized conference program features a stunning assembly of speakers and thought leaders. Through presentations, case studies and panel discussions, attendees will learn about the latest in In silico and systems biology approaches to drug discovery, IT challenges in buildling the UK Biobank, databases for biomolecular information, advances in high-performance computing, including Blue Gene, and applications of the semantic web. Register Today: http://www.bio-itworldexpo.com/live/26/register

Bio-IT World Best Practices Awards - Call for Entries - Deadline March 15
Enter the third annual Best Practices Awards recognizing the innovative use of technology and business strategies to accelerate the drug discovery and R&D process. Submit your entry by January 30th and receive 50% off the entry fee price.  Visit
 www.bio-itworld.com/bestpractices/ for more information.



Capgemini Analysis  

Enterprise Contract Management 

By Mauro Caputi

Senior Manager, Life Sciences Practice

ECM Solutions Leader, Capgemini


As the life sciences industry looks in vain for the next blockbuster to boost its finances, a potentially lucrative source of profit and revenue is staring many life sciences firms in the face.


The fact is that failure to manage commercial contracts professionally is costing life sciences billions of dollars worldwide every year. Conversely, adopting an Enterprise Contract Management (ECM) strategy can generate serious revenues and cost savings, and minimize business risk.


What is ECM? Quite simply it is the practice of addressing and implementing improvements for the entire contracting process - from initiation to compliance, assessment and refinement - across the life sciences organization. Its aim is to ensure that contractual commitments are met and that pricing and terms are optimized for better business performance and stronger customer-supplier relationships.

    Read More . . . 

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