http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory/Article/list/44907 Practical information for clinical research professionals in industry and academia who develop, execute and manage clinical trials worldwide. Regular topics include regulatory affairs, protocol development, data management and harmonization updates. 2009-11-21T03:47:44Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Safety-Requirements-Slow-New-Drug-Approvals/ArticleStandard/Article/detail/640470?contextCategoryId=44907&ref=25 FDA reviewers strive to assess new postmarketing programs while also evaluating applications. 2009-11-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/462009/640470null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Conducting-Trials-in-Croatia/ArticleStandard/Article/detail/641182?contextCategoryId=44907&ref=25 As a part of Europe, but not the European Union, trials in Croatia can encounter special challenges 2009-11-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/462009/641182/Croatia-map_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Great-Expectations-CROs-Face-Change-in-Italy/ArticleStandard/Article/detail/640459?contextCategoryId=44907&ref=25 How Italy's new quality-driven regulations will ask more of CROs conducting activities in the country. 2009-11-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/462009/640459/Italy-map_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/Health-Issues-Raise-EUs-Regulatory-Profile/ArticleStandard/Article/detail/640468?contextCategoryId=44907&ref=25 Health concerns require EU regulators to become more involved in the politics of health care. 2009-11-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/462009/640468null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/640467?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession 2009-11-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/462009/640467null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Schulman-Associates-IRB-Establishes-Itself-in-Cana/ArticleStandard/Article/detail/637258?contextCategoryId=44907&ref=25 2009-10-28T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/442009/637258null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/REMs-Battling-the-Unknowns/ArticleStandard/Article/detail/636006?contextCategoryId=44907&ref=25 Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development. 2009-10-22T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/432009/636006/REMs_Image_2_again_flash.jpg HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/European-Medicines-Agency-Implements-Internal-Reor/ArticleStandard/Article/detail/631491?contextCategoryId=44907&ref=25 2009-10-05T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/412009/631491null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Keys-to-Drug-Development-in-Latin-America/ArticleStandard/Article/detail/630600?contextCategoryId=44907&ref=25 The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market. 2009-10-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/402009/630600/act_Covolho_0909_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/Working-Toward-a-Better-Future/ArticleStandard/Article/detail/632982?contextCategoryId=44907&ref=25 The EU struggles to get over its regulatory hurdles in an effort to further R&D success. 2009-10-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/412009/632982null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/632980?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession 2009-10-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/412009/632980null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/FDA-Promotes-Integrity-and-Compliance/ArticleStandard/Article/detail/632984?contextCategoryId=44907&ref=25 Stiffer enforcement of research standards aims to restore the public's confidence in agency actions. 2009-10-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/412009/632984null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Pressure-Mounts-for-ICH-GCP-Revisions/ArticleStandard/Article/detail/632979?contextCategoryId=44907&ref=25 The ICH GCP guideline continues to age and while members of the Institute of Clinical Research voice the need for its revision, industry debates whether changes are necessary. 2009-10-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/412009/632979null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/BSI-Launches-New-CE-Dedicated-FastTrack-Program/ArticleStandard/Article/detail/629098?contextCategoryId=44907&ref=25 2009-09-24T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/392009/629098null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Time-to-Review-ICH-GCP-Guidelines-Say-ICR-Members/ArticleStandard/Article/detail/625053?contextCategoryId=44907&ref=25 2009-09-09T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/625053null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/EMEA-and-FDA-Team-Up-on-GCP/ArticleStandard/Article/detail/624938?contextCategoryId=44907&ref=25 The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections. 2009-09-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/624938null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/624941?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession 2009-09-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/624941null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/FDA-Takes-on-Addiction/ArticleStandard/Article/detail/624937?contextCategoryId=44907&ref=25 Abuse and misuse of extended-relief opioids, get regulatory attention and potential guidance from Onsolis' REMS. 2009-09-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/624937null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Global-Development-Challenges-Sponsors/ArticleStandard/Article/detail/624934?contextCategoryId=44907&ref=25 International health crises expand testing of new vaccines and drug treatments for third-world diseases. 2009-09-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/624934null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Regulating-the-Generic-Drug-Process/ArticleStandard/Article/detail/624944?contextCategoryId=44907&ref=25 Guidance for the design and conduct of international bioequivalence trials. 2009-09-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/372009/624944/act_Wood_0909_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/FDA-Proposes-Mandatory-Electronic-Safety-Reporting/ArticleStandard/Article/detail/620774?contextCategoryId=44907&ref=25 2009-08-21T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/342009/620774null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/REMS-Group-Offers-Consulting-Services/ArticleStandard/Article/detail/620761?contextCategoryId=44907&ref=25 2009-08-21T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/342009/620761null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/The-eCTD-Advantage/ArticleStandard/Article/detail/620544?contextCategoryId=44907&ref=25 Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND. 2009-08-20T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/342009/620544null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Covance-Receives-MHRA-Accreditation-for-UK-Facilit/ArticleStandard/Article/detail/616048?contextCategoryId=44907&ref=25 2009-08-03T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/616048null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/WHO-Boosts-Research-in-Africa/ArticleStandard/Article/detail/617461?contextCategoryId=44907&ref=25 Vital players come together in an attempt to find a cure for a devastating illness predominantly effecting African countries. 2009-08-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/617461null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Therapeutics/A-Market-Worth-Watching/ArticleStandard/Article/detail/617464?contextCategoryId=44907&ref=25 A look at the growing market of dietary supplements and the potential for development of these products in the clinical trials arena. 2009-08-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/617464null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Health-Reform-Shapes-Drug-Development/ArticleStandard/Article/detail/617460?contextCategoryId=44907&ref=25 Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table. 2009-08-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/617460null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/617471?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-08-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/617471null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/Disharmony-Stifling-Research-in-Europe/ArticleStandard/Article/detail/617465?contextCategoryId=44907&ref=25 Contradicting decisions call for a unified clinical trial authorization process. 2009-08-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/322009/617465null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Demystifying-India/ArticleStandard/Article/detail/615145?contextCategoryId=44907&ref=25 Understanding common myths and truths surrounding one of the fastest growing clinical trial markets. 2009-07-31T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/312009/615145/act_McDon_0809_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Reviewing-ICRs-Guide-to-the-Clinical-Trial-Directi/ArticleStandard/Article/detail/612963?contextCategoryId=44907&ref=25 A look at the Pocket Guide to the EU Directives for Clinical Research, published by the Institute of Clinical Research. 2009-07-22T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/302009/612963null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/White+Papers/New-Dimensions-in-EDCeClinical-TMF-and-Document-Ma/ArticleStandard/Article/detail/612105?contextCategoryId=44907&ref=25 Non-digital data recording mechanisms have existed for millennia, and due to the inherent nature of the media have produced a distinctly linear thought pattern in most activities including clinical research management. Digital data recording methods, however, open up a broad range of possibilities for data access and capture to operate on a distinctly non-linear fashion. This whitepaper explores what may be achieved with the appropriate Vision, specifically with respect to Trial Master Files and Document Management. 2009-07-17T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/292009/612105null REMOTE http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/The-Origins-of-Research-Ethics/ArticleStandard/Article/detail/610780?contextCategoryId=44907&ref=25 Out of the horrors of World War II came the Nuremberg Code, the prototype for human research protection. 2009-07-13T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/292009/610780null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/FDA-Signs-Three-Year-Maintenance-and-Support-Agree/ArticleStandard/Article/detail/609263?contextCategoryId=44907&ref=25 2009-07-07T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/282009/609263null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+Articles/Support-for-UK-Pediatric-Studies/ArticleStandard/Article/detail/609447?contextCategoryId=44907&ref=25 Inside the Medicines for Children Research Network and its work to improve medicines for the young. 2009-07-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/282009/609447null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/609450?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-07-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/282009/609450null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Drug+Development/EU-Looks-Closer-at-Pharmacovigilance/ArticleStandard/Article/detail/609448?contextCategoryId=44907&ref=25 European Union health ministers begin reviewing proposals to better adverse event assessment in Europe. 2009-07-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/282009/609448null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Safety-amp-Transparency-Shape-Drug-Development/ArticleStandard/Article/detail/609456?contextCategoryId=44907&ref=25 FDA leaders stress innovation and disclosure in promoting the agency's public health mission. 2009-07-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/282009/609456null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Commissioner-Hamburg-on-Global-Drug-Regulation-and/ArticleStandard/Article/detail/607079?contextCategoryId=44907&ref=25 Jill Wechsler provides a special report of a briefing with FDA's new commissioner Margaret Hamburg. 2009-06-29T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/272009/607079null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Familiarity-Breeds-Understanding/ArticleStandard/Article/detail/605959?contextCategoryId=44907&ref=25 How FDA is responding to the demands of a global world, where agency-regulated products are in the trillions. 2009-06-23T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/262009/605959null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Development-of-Oncology-Products/ArticleStandard/Article/detail/605964?contextCategoryId=44907&ref=25 Session poses the question can we do better? 2009-06-23T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/262009/605964null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/ACRO-Statement-Supporting-the-Patient-Centered-Out/ArticleStandard/Article/detail/602993?contextCategoryId=44907&ref=25 2009-06-11T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/242009/602993null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/An-EMR-Update/ArticleStandard/Article/detail/602657?contextCategoryId=44907&ref=25 A current look at FDA's role in electronic medical records. 2009-06-10T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/242009/602657null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Clinical-Research-Under-Scrutiny/ArticleStandard/Article/detail/602041?contextCategoryId=44907&ref=25 Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602041null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Common-Ground-for-eCTD/ArticleStandard/Article/detail/602040?contextCategoryId=44907&ref=25 Roundtable participants discuss challenges and successes with early eCTD implementation. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602040null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-News/ArticleStandard/Article/detail/602033?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602033null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Medical-Device-Compliance/ArticleStandard/Article/detail/602042?contextCategoryId=44907&ref=25 A probability sampling assessment by FDA takes a look at compliance in the medical device world. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602042/act_Marcarelli_0609_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Therapeutics/Treating-Stress-in-Patients-in-Europe/ArticleStandard/Article/detail/602044?contextCategoryId=44907&ref=25 EMEA releases new guideline for studies in PTSD, as new figures depict a lagging EU. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602044null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Global-Supply-Chain-Management/ArticleStandard/Article/detail/602049?contextCategoryId=44907&ref=25 What managers must know and do to overcome regulatory challenges and avoid hiccups. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602049/act_Lis_0609_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+News/New-FDA-Liaison-Opens-Up/ArticleStandard/Article/detail/602035?contextCategoryId=44907&ref=25 Hear from the first FDA liaison in the Office of International Programs. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/232009/602035null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/IT/What-Do-You-Want-to-Know-A-Readers-Survey-Tells-Al/ArticleStandard/Article/detail/602478?contextCategoryId=44907&ref=25 Learn what Applied Clinical Trial's readers told us in our annual reader's survey. 2009-06-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/242009/602478null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/EU-and-the-Swine-Flu/ArticleStandard/Article/detail/600337?contextCategoryId=44907&ref=25 A look into how the European Union is handling the daunting health threats of the swine flu. 2009-05-28T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/222009/600337null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Have-questions-about-FDA-1572s/ArticleStandard/Article/detail/599035?contextCategoryId=44907&ref=25 FDA has updated its guidance documents for 1572s. 2009-05-20T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/212009/599035null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Selecting-an-eCTD-Vendor/ArticleStandard/Article/detail/597525?contextCategoryId=44907&ref=25 Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor. 2009-05-11T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/202009/597525null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Responding-to-a-Critique-of-the-Industry/ArticleStandard/Article/detail/597620?contextCategoryId=44907&ref=25 Critical comments of the drug evaluation process bring about strong reaction from industry. 2009-05-11T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/202009/597620null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/President-Makes-Budget-Request-for-FDA/ArticleStandard/Article/detail/597148?contextCategoryId=44907&ref=25 2009-05-07T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/192009/597148null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/Comparative-Research-to-Shape-Clinical-Trials/ArticleStandard/Article/detail/597462?contextCategoryId=44907&ref=25 Government funding slated to boost studies comparing medications to other treatments. 2009-05-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/192009/597462null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/ICR-Launches-New-Guide-to-the-EU-Directives/ArticleStandard/Article/detail/596114?contextCategoryId=44907&ref=25 2009-05-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/182009/596114null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/597459?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-05-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/192009/597459null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+News/Regulatory-Relations/ArticleStandard/Article/detail/597464?contextCategoryId=44907&ref=25 The U.S.–EU Transatlantic Administrative Simplication Plan continues on the road of development. 2009-05-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/192009/597464null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/Advancing-New-Therapies-in-Europe/ArticleStandard/Article/detail/597452?contextCategoryId=44907&ref=25 Changing rules on advanced therapy medicinal products to require more from clinical studies. 2009-05-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/192009/597452null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Train-Your-Employees-to-Better-eCTD-Submissions/ArticleStandard/Article/detail/593330?contextCategoryId=44907&ref=25 Shire Pharmaceuticals' Carol Rutkowski explains the benefits of training employees in regard to the regulatory eCTD submissions world. 2009-04-27T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/162009/593330null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Consider-a-Consultant/ArticleStandard/Article/detail/593332?contextCategoryId=44907&ref=25 Hear about the benefits of bringing in an objective outsider when implementing an eCTD software. 2009-04-24T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/162009/593332null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Pilot-Test-Your-eCTD-Software/ArticleStandard/Article/detail/593328?contextCategoryId=44907&ref=25 An interview with Dr. Albert Edwards offers his take on how pilot testing can ease the implementation of eCTD. 2009-04-21T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/162009/593328null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Coast-Issued-Warning-Letter-by-FDA/ArticleStandard/Article/detail/593366?contextCategoryId=44907&ref=25 2009-04-14T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/162009/593366null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/eCTD-Moving-from-Paper-to-Electronic/ArticleStandard/Article/detail/589126?contextCategoryId=44907&ref=25 Hear from Quintiles' senior director of global regulatory affairs and medical writing on moving from a paper to electronic submission. 2009-04-02T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/132009/589126null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Health-IT-Offers-Both-Promise-and-Problems/ArticleStandard/Article/detail/591990?contextCategoryId=44907&ref=25 Biomedical research community finds privacy policies add cost and complexity to clinical studies. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/152009/591990null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Make-That-an-e-Please/ArticleStandard/Article/detail/591984?contextCategoryId=44907&ref=25 A recent roundtable discussion on eCTD highlights issues related to the industry wide switch from paper to electronic. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/152009/591984null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+News/Italy-Heightens-Rules-for-CROs/ArticleStandard/Article/detail/591988?contextCategoryId=44907&ref=25 Regulatory authorities in Italy enforce new legislation that hardens the requirements for education and certification of staff at CROs. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/152009/591988null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Drug+Development/Partnering-in-CHINA/ArticleStandard/Article/detail/591070?contextCategoryId=44907&ref=25 Best practices for selecting a central lab partner in this popular trial destination. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/142009/591070/act_dicarlo_0409_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/591997?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/152009/591997null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/The-Rarity-Value/ArticleStandard/Article/detail/591991?contextCategoryId=44907&ref=25 As EU debates plans for advancing R&D in rare diseases, industry assesses the risks and benefits. 2009-04-01T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/152009/591991null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Documents-from-Congress-hearing-regarding-IRBs-tha/ArticleStandard/Article/detail/590113?contextCategoryId=44907&ref=25 2009-03-30T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/142009/590113null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory/FDA-Update-Under-the-Obama-Administration/ArticleStandard/Article/detail/587496?contextCategoryId=44907&ref=25 New leadership and more resources aim to modernize FDA operations. 2009-03-16T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/122009/587496null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Meeting-Highlights-from-the-Paediatric-Committee-M/ArticleStandard/Article/detail/587016?contextCategoryId=44907&ref=25 2009-03-13T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/587016null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/EMEA-Re-Elects-Vice-Chair-and-Discusses-Budget-for/ArticleStandard/Article/detail/586736?contextCategoryId=44907&ref=25 2009-03-12T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586736null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Congressional-Sting-Operation-Uncovered/ArticleStandard/Article/detail/586669?contextCategoryId=44907&ref=25 2009-03-12T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586669null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Clinical-Trial-Fraud-Detected-by-IRB/ArticleStandard/Article/detail/586309?contextCategoryId=44907&ref=25 2009-03-11T04:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586309null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Electronic-Trial-Master-Files/ArticleStandard/Article/detail/587074?contextCategoryId=44907&ref=25 A European perspective on the challenges of paper files and the value of its replacement. 2009-03-02T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/587074null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Digitizing-Signatures/ArticleStandard/Article/detail/587075?contextCategoryId=44907&ref=25 Because PKI digital signatures are standards based, electronic records can actually be retained for decades. 2009-03-02T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/587075null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Drug+Development/Closer-to-Transparency/ArticleStandard/Article/detail/586859?contextCategoryId=44907&ref=25 London conference underscores foggy climate surrounding clinicaltrials.gov 2009-03-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586859null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/Make-New-Friends/ArticleStandard/Article/detail/586856?contextCategoryId=44907&ref=25 Doing more, and doing more with less, means new business ties outside and within your company. 2009-03-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586856null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Drug+Development/EU-Born-HIV-Study-History-in-the-Making/ArticleStandard/Article/detail/586862?contextCategoryId=44907&ref=25 Ten-year-old study sets precedent for future collaborative observational studies on drug safety. 2009-03-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586862null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Transparency-Shapes-Pharmaceutical-RampD/ArticleStandard/Article/detail/586861?contextCategoryId=44907&ref=25 Reformers seek disclosure of investigator payments and conflicts of interest. 2009-03-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/112009/586861null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/EMEA-EFPIA-Information-Day-2009/ArticleStandard/Article/detail/583572?contextCategoryId=44907&ref=25 2009-02-26T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/092009/583572null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Mosaiques-and-FDA-Sign-Contract-for-Collaboration/ArticleStandard/Article/detail/583078?contextCategoryId=44907&ref=25 2009-02-24T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/092009/583078null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Congress-Approves-Down-Payment-on-Health-Reform/ArticleStandard/Article/detail/582527?contextCategoryId=44907&ref=25 The stimulus bill expands the health care safety net while boosting investment in health IT and comparative research. 2009-02-19T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/082009/582527null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Meeting-Highlights-from-EUs-Paediatric-Committee/ArticleStandard/Article/detail/581717?contextCategoryId=44907&ref=25 2009-02-17T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/082009/581717null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/EFPIA-Addresses-the-European-Commissions-Pharmaceu/ArticleStandard/Article/detail/581888?contextCategoryId=44907&ref=25 2009-02-17T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/082009/581888null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/eSubs-and-eCTD-and-RPS-Oh-My/ArticleStandard/Article/detail/582054?contextCategoryId=44907&ref=25 An opinion from Leah Kleylein, a principal consultant for product management, on the technicalities of publishing a regulatory submission. 2009-02-17T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/082009/582054null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/An-EU-and-US-Integration-Strategy/ArticleStandard/Article/detail/581039?contextCategoryId=44907&ref=25 How regulatory agencies on both sides of the Atlantic are working toward transatlantic harmonization. 2009-02-14T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/072009/581039/act_mudge_0209_flash.jpg XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/Nextrials-Pledges-Support-for-ANSIs-Latest-Initiat/ArticleStandard/Article/detail/581476?contextCategoryId=44907&ref=25 2009-02-13T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/072009/581476null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Clinical-Trials-Results-Reporting-Update-from-Lond/ArticleStandard/Article/detail/579658?contextCategoryId=44907&ref=25 From London, Applied Clinical Trial's Editor-in-Chief Lisa Henderson provides an update on CBI's Inaugural Clinical Trial Registries and Results Databases conference. 2009-02-04T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579658null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Regional-Differences-in-Medical-Device-Development/ArticleStandard/Article/detail/579063?contextCategoryId=44907&ref=25 Exploring the impact of European regulatory changes on the differences in medical device development and approval between the EU and the US. 2009-02-03T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579063null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/News/FDA-Embraces-a-New-Review-Process-and-Approves-SNM/ArticleStandard/Article/detail/578886?contextCategoryId=44907&ref=25 2009-02-02T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/578886null HTML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+News/Business-and-People-Update/ArticleStandard/Article/detail/579333?contextCategoryId=44907&ref=25 Industry news focusing on the people and organizations who work in the clinical trials profession. 2009-02-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579333null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+Articles/A-Healthy-2009-for-the-European-Union/ArticleStandard/Article/detail/579326?contextCategoryId=44907&ref=25 What to expect from the new leadership and why there's not much hope for an improved directive. 2009-02-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579326null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+News/Is-Two-a-Crowd/ArticleStandard/Article/detail/579323?contextCategoryId=44907&ref=25 Clearing up the misunderstandings that often arise when bringing a product combining a dietary supplement and prescription drug to market. 2009-02-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579323null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Health-Reform-Targets-Costs-and-Coverage/ArticleStandard/Article/detail/579438?contextCategoryId=44907&ref=25 Proposals to reduce outlays for drugs could limit biomedical research and product development. 2009-02-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579438null XML http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Ethnic-Trials-Bridge-Global-Gaps/ArticleStandard/Article/detail/579324?contextCategoryId=44907&ref=25 Bridging studies help pave the way for more efficient global drug development in the Asia-Pacific region. 2009-02-01T05:00:00Z http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/062009/579324null XML