Get the latest information from Applied Clinical Trials delivered straight to your iPod or favorite MP3 listening device. http://act.scpodcasts.com/home.htm Copyright 2008 Advanstar Communications en-us Mon, 10 Aug 2009 11:24:35 -0700 webmaster@scpodcasts.com (Webmaster) Mon, 10 Aug 2009 06:49:26 -0700 FeedForAll v2.0 (2.0.2.9) http://www.feedforall.com Applied Clinical Trials Podcast Applied Clinical Trials Podcast Advanstar Communications Advanstar Communications webmaster@scpodcasts.com Medical, Clinical no no http://act.scpodcasts.com/images/podlogo.jpg http://act.scpodcasts.com/home.htm 144 144 How has the role of Regulatory Affairs evolved? Armed with results from a Tufts CSDD 2008/2009 study, Kenneth Getz, MBA, explains how, providing a vivid analysis of the expectations, responsibilities, and required skills of today´s Regulatory Affairs professional. http://appliedclinicaltrialsonline.findpharma.com/podcasts 145C852A-FF44-448D-9313-0C3A25C9E8FC Mon, 1 Jun 2009 11:11:29 -0700 Behind-the-Scenes with Regulatory Affairs How has the role of Regulatory Affairs evolved? Armed with results from a Tufts CSDD 2008/2009 study, Kenneth Getz, MBA, explains how, providing a vivid analysis of the expectations, responsibilities, and required skills of today´s Regulatory Affairs professional. 10:42 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Felix Gyi, PharmD, MBA, CEO of Chesapeake Research Review discusses ethical rewards for patients in clinical studies and how the relationships between pharma and health care professionals affects subject recruitment and retention. http://appliedclinicaltrialsonline.findpharma.com/podcasts 796CE917-9736-40B3-B9AC-1AFCC7339385 Mon, 1 Jun 2009 11:07:30 -0700 Rewards for Subjects, an Ethical Dilemma? Felix Gyi, PharmD, MBA, CEO of Chesapeake Research Review discusses ethical rewards for patients in clinical studies and how the relationships between pharma and health care professionals affects subject recruitment and retention. 6:02 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Nancy D. Smith, PhD, former director, office of training and communications, CDER, FDA, discusses this year's meeting theme, "Better Medicines: Improving Safety with Every Step," and the CDER Town Meeting that has become a DIA staple http://appliedclinicaltrialsonline.findpharma.com/podcasts B9E2F926-FC6F-404E-B198-6FBA4B171871 Mon, 1 Jun 2009 11:04:04 -0700 Meet DIA's Program Chair Nancy D. Smith, PhD, former director, office of training and communications, CDER, FDA, discusses this year's meeting theme, "Better Medicines: Improving Safety with Every Step," and the CDER Town Meeting that has become a DIA staple. 7:08 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Valerie Mackner of Wyeth Pharmaceuticals discusses moving from in-house eCTD software to an off-the-shelf product. http://appliedclinicaltrialsonline.findpharma.com/podcasts 653A32AB-CE8D-4A1A-BFEB-CA3C0C5FF509 Wed, 1 Apr 2009 11:19:30 -0700 eCTD: In-house eCTD vs. Off-the-Shelf Software Valerie Mackner of Wyeth Pharmaceuticals discusses moving from in-house eCTD software to an off-the-shelf product. 2:15 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Veteran regulatory affairs professional Dr. Albert Edwards, PharmD, RAC, Director, Regulatory Operations, Takeda offers his views for eCTD implementation in the future http://appliedclinicaltrialsonline.findpharma.com/podcasts B40117EB-7488-481E-A8EF-4B35B3F8EE19 Wed, 1 Apr 2009 10:34:11 -0700 eCTD: Pilot Testing eCTD Software Veteran regulatory affairs professional Dr. Albert Edwards, PharmD, RAC, Director, Regulatory Operations, Takeda offers his views for eCTD implementation in the future 2:18 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Shire Pharmaceuticals’ Carol Rutkowski, Senior Director, Global Regulatory Operations, Shire explains the benefits of training employees in regard to the regulatory eCTD submissions world. http://appliedclinicaltrialsonline.findpharma.com/podcasts 19DC98C5-5A1D-4B02-ACFF-C1467A89B1C8 Wed, 1 Apr 2009 10:31:07 -0700 eCTD: Training Employees on eCTD Shire Pharmaceuticals’ Carol Rutkowski, Senior Director, Global Regulatory Operations, Shire explains the benefits of training employees in regard to the regulatory eCTD submissions world. 4:01 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Michael J. McGraw, PharmD, MS, regulatory affairs manager at Teva Neuroscience, discusses the benefits of bringing in an objective outsider. http://appliedclinicaltrialsonline.findpharma.com/podcasts 77698462-46B3-47CE-B1E6-AC1CFE560810 Wed, 1 Apr 2009 06:58:04 -0700 eCTD: Bringing in an Objective Outsider Michael J. McGraw, PharmD, MS, regulatory affairs manager at Teva Neuroscience, discusses the benefits of bringing in an objective outsider. 2:48 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Janel Firestein,(Associate Partner, Clarkston Consulting) our roundtable moderator, offers her take on the expert discussion and the major challenge she sees to eCTD implementation. http://appliedclinicaltrialsonline.findpharma.com/podcasts ACT-09-17 Wed, 1 Apr 2009 06:49:20 -0700 eCTD: Challenges to eCTD Janel Firestein,(Associate Partner, Clarkston Consulting) our roundtable moderator, offers her take on the expert discussion and the major challenge she sees to eCTD implementation. 2:48 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Laurie Henricks (Senior Director, Global Regulatory Affairs and Medical Writing, Quintiles) tells us how--in her CRO capacity--she coaches sponsor/clients to get more comfortable with moving from paper submissions to electronic submissions. http://appliedclinicaltrialsonline.findpharma.com/podcasts ACT-09-16 Wed, 1 Apr 2009 09:17:42 -0700 eCTD: Moving from Paper to Electronic Submissions Laurie Henricks (Senior Director, Global Regulatory Affairs and Medical Writing, Quintiles) tells us how--in her CRO capacity--she coaches sponsor/clients to get more comfortable with moving from paper submissions to electronic submissions. 4:12 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Mark Ware, Director, Clinical Trial Services at IDIS, explains how procurement teams charged with sourcing comparator drugs for clinical trials can move from a tactical sourcing approach to a strategic approach. http://appliedclinicaltrialsonline.findpharma.com/podcasts ACT-09-15 Wed, 1 Apr 2009 09:13:47 -0700 Ins & Outs of Comparator Drug Sourcing Mark Ware, Director, Clinical Trial Services at IDIS, explains how procurement teams charged with sourcing comparator drugs for clinical trials can move from a tactical sourcing approach to a strategic approach. 16:43 Applied Clinical Trials Magazine Clinical Trials, Medicine no no Viq Pervaaz, VP, Global Project Management MDS Pharma Services, speaks to Applied Clinical Trials Editor in Chief Lisa Henderson about the challenges associated with clinical trials in China. Pervaaz highlights specimen management, regional requirements and other insights he will share at the Partnerships with CROs and Clinical Providers conference in Orlando later this month. http://appliedclinicaltrialsonline.findpharma.com/podcasts ACT-09-14 Wed, 1 Apr 2009 09:03:05 -0700 Global Trial Considerations Viq Pervaaz, VP, Global Project Management MDS Pharma Services, speaks to Applied Clinical Trials Editor in Chief Lisa Henderson about the challenges associated with clinical trials in China. Pervaaz highlights specimen management, regional requirements and other insights he will share at the Partnerships with CROs and Clinical Providers conference in Orlando later this month. 16:40 Applied Clinical Trials Magazine Clinical Trials, Medicine no no