This independent CME/CE activity is supported by educational grants from Bristol-Myers Squibb, Schering-Plough Corporation, and Vertex Pharmaceuticals Incorporated.
Bruce R. Bacon, MD
James F. King MD Endowed
Chair in Gastroenterology
Professor of Internal Medicine
Director, Division of
Gastroenterology and
Hepatology
Saint Louis University
Liver Center
Saint Louis University
School of Medicine
St. Louis, Missouri
Adrian M. Di Bisceglie, MD, FACP
Professor of Internal Medicine
Chief of Hepatology
Saint Louis University
School of Medicine
St. Louis, Missouri
Douglas T. Dieterich, MD
Professor of Medicine
Director, Continuing Medical
Education
Mount Sinai School of Medicine
New York, New York
Robert G. Gish, MD
Medical Director
Liver Transplant Program
Chief, Division of Hepatology and
Complex GI
California Pacific Medical Center
San Francisco, California
Ira M. Jacobson, MD
Vincent Astor Professor of
Clinical Medicine
Chief, Division of
Gastroenterology and Hepatology
Medical Director of the Center
for the Study of Hepatitis C
Weill Medical College of Cornell
University
New York, New York
Ching-Lung Lai, MD
Professor of Medicine and
Hepatology
Department of Medicine
University of Hong Kong
Queen Mary Hospital
Hong Kong, China
Pietro Lampertico, MD
Gastroenterology Unit
University of Milan
Milan, Italy
John G. McHutchison, MD, FRACP
Director,
Gastroenterology/Hepatology
Research
Duke Clinical Research Institute
Professor of Medicine
Duke University Medical Center
Durham, North Carolina
David R. Nelson, MD
Associate Professor of
Medicine
Chief, Section of
Hepatobiliary Diseases
Medical Director,
Liver Transplantation
Division of Gastroenterology,
Hepatology, & Nutrition
University of Florida,
Department of Medicine
Gainesville, Florida
Paul J. Pockros, MD
Head, Division of
Gastroenterology/Hepatology
Scripps Clinic
La Jolla, California
Stefan Zeuzem, MD
Professor of Medicine
Department of
Internal Medicine II
Gastroenterology, Hepatology,
and Endocrinology
University Hospital
Homburg/Saar, Germany
Statement of Accreditation
Projects In Knowledge is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Credit Designation
Projects In Knowledge designates this educational activity for a maximum of .25 AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
This activity is planned and implemented as an independent CME activity in accordance with the ACCME Essential Areas and Policies.
You can earn up to 1 credit for completing the entire 4-part series.
This activity has been approved by the American Association of Critical-Care Nurses (AACN) for a maximum of 0.5 contact hour. Provider #00012705. (Nurses can earn up to 2.0 credits by completing all four parts.)
The goal of this CME/CE activity is to provide clinicians with new clinical insights into current and emerging HCV and HBV treatment therapies and their potential role in improving patient outcomes.
This CME/CE activity is designed for gastroenterologists, hepatologists, and other clinicians who treat patients with HBV and HCV infection.
Assess the latest efficacy and safety data on current as well as emerging therapies—protease and polymerase inhibitors—to distinguish among these agents as future therapeutic options in the treatment of patients with HCV infection.
Formulate HBV treatment strategies, considering safety, efficacy, endpoints, and resistance patterns of currently available and emerging antiviral agents, to improve response rates in patients with HBV infection.
Projects In Knowledge has developed the contract to demonstrate our commitment to providing the highest
quality professional education to clinicians, and to help clinicians set educational goals to challenge and enhance their learning experience.
For more information on the contract, please click here.
The Disclosure Policy of Projects In Knowledge requires that presenters comply with the Standards for Commercial Support. All faculty are required to disclose any personal interest or relationship they or their spouse/partner have with the supporters of this activity or any commercial interest that is discussed in their presentation. Any discussions of unlabeled/unapproved uses of drugs or devices will also be disclosed.
For complete prescribing information on the products discussed during this CME/CE activity, please see your current Physicians’ Desk Reference (PDR).
Peer Reviewer has no significant relationships to disclose.
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Conflicts of interest are thoroughly vetted by the Executive Committee of Projects In Knowledge. All conflicts are resolved prior to the beginning of the activity by the Trust In Knowledge peer review process.
The opinions expressed in this activity are those of the faculty and do not necessarily reflect those of Projects In Knowledge.
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Editorial developed by
Projects In Knowledge, Inc.
Copyright © 2006-2008
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Part 1
Est. download time 56k: 10 min., Broadband: 2 min.
Program Series Chair
Bruce R. Bacon, MD
Listen to the first of 4 daily podcasts, which focuses on standard & emerging interferon/RBV anti-HCV treatments.
In this first installment of Newsmakers In Medicine, the Hepatology Edition, three investigators discuss studies on treatment for chronic hepatitis C.
In the first presentation, Dr. Adrian Di Bisceglie, Professor of Internal Medicine, Chief of Hepatology, at Saint Louis University School of Medicine, discusses the results from a prospective 5-year cohort study evaluating long-term results for patients with chronic hep C treated with standard interferon alfa-2b or pegylated interferon plus ribavirin. In this presentation, Dr. Di Bisceglie describes data suggesting that individuals with chronic hepatitis C who achieve a sustained viral response are at very low risk for virologic relapse and have continued improvement in liver histology over a 5-year period. View Abstract 337 
In the second presentation, our series chair Dr. Bruce Bacon, Professor of Internal Medicine, Director, Division of Gastroenterology and Hepatology, at the Saint Louis School of Medicine, talks about interim results from the DIRECT trial, a randomized, phase III open-label study evaluating the sustained virologic response of combination therapy with interferon alfacon-1 plus two different doses of ribavirin in hepatitis C patients with documented nonresponse to previous pegylated interferon plus ribavirin therapy. View Abstract LB18
In the third presentation, Dr. David Nelson, Chief, Section of Hepatobiliary Diseases, at the University of Florida, discusses the interim results from two phase II studies evaluating albumin interferon alfa-2b in combination with ribavirin in patients with chronic hep C. One of the studies evaluated response in interferon-naive patients, while the other looked at response in nonresponders to prior interferon therapy. View Abstract 1136 View Abstract 1141
Release Date: October 31, 2006.
Termination Date: October 31, 2007.
Estimated time for completion: 15 minutes.
Bruce R. Bacon, MD, has received grant/research support from Axcan Pharma, Bristol-Myers Squibb, Coley Pharmaceutical Group, Gilead Sciences, Inc, GlaxoSmithKline, InterMune Inc, Isis Pharmaceuticals, National Institutes of Health, Roche Pharmaceuticals, Schering-Plough Corporation, and Valeant Pharmaceuticals International; is a consultant for Bayer Diagnostics (ad hoc), Coley Pharmaceutical Group, InterMune Inc, Isis Pharmaceuticals, Resonance Health, Schering-Plough Corporation, Serono International (ad hoc), and Valeant Pharmaceuticals International; is on the speakers bureau of Axcan Pharma, Gilead Sciences, Inc, and Schering-Plough Corporation; and has served on advisory boards for Genetrol Biotherapeutics, GlaxoSmithKline (hepatitis advisory board), and Novartis Pharmaceuticals Corporation.
Adrian M. Di Bisceglie, MD, FACP, has received grant/research support from Gilead Sciences, Inc, Idenix Pharmaceuticals Inc, Roche Pharmaceuticals, SciClone Pharmaceuticals, Schering-Plough Corporation, and Vertex Pharmaceuticals Incorporated; is a consultant for Abbott Laboratories, Bristol-Myers Squibb Company, Chiron Corporation, and SciClone Pharmaceuticals; is on the speakers bureau of Bristol-Myers Squibb Company, Gilead Sciences, Inc, Roche Pharmaceuticals, and Schering-Plough Corporation; is a member of advisory boards for Bristol-Myers Squibb Company, Idenix Pharmaceuticals, Inc, Novartis Pharmaceuticals Corporation, Roche Pharmaceuticals, and Vertex Pharmaceuticals Incorporated; and is a member of Data Safety Monitoring Board for Schering-Plough Corporation.
David R. Nelson, MD, has received grant/research support from Human Genome Sciences, Idenix Pharmaceuticals, Roche Pharmaceuticals, Schering-Plough Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals Incorporated; is a consultant for Bristol-Myers Squibb, Idenix Pharmaceuticals, Roche Pharmaceuticals, and Vertex Pharmaceuticals Incorporated; is on the speakers bureau of Roche Pharmaceuticals and Schering-Plough Corporation; and has served on advisory boards for Coley Pharmaceutical Group, Idenix Pharmaceuticals, Roche Pharmaceuticals, and Vertex Pharmaceuticals Incorporated. Dr. Nelson has disclosed that he will reference the unlabeled/unapproved use of albuferon in his presentation.
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Part 2
Est. download time 56k: 10 min., Broadband: 2 min.
Listen to the second of 4 daily podcasts, which presents the latest developments on current and emerging treatments for chronic HBV and HCV.
In the second installment of Newsmakers In Medicine, the Hepatology Edition, presenters discuss 3 year data for entecavir in the treatment of chronic hepatitis B virus infection, data on telaprevir & peginterferon in the suppression of wild type and resistance variants for genotype 1 HCV patients, and the use of taribavirin, versus ribavirin, in combination with pegylated interferon, as treatment for chronic hepatitis C virus infection.
In the first presentation, Dr. Robert Gish, Medical Director, Liver Transplant Program, Chief, Division of Hepatology and Complex GI, at California Pacific Medical Center in San Francisco discusses maintenance of virologic suppression and emergence of resistance in chronic hep b nucleoside-naive patients receiving 3 years of entecavir treatment. View Abstract 109 View Abstract 110
Then Dr. Gish describes hep B antigen loss and seroconversion with entecavir or lamividine treatment in a study of 709 patients. View Abstract 992
In the second presentation, Dr. Stefan Zeuzem Professor of Medicine, Department of Gastroenterology, Hepatology, and Endocrinology, at University Hospital, Homburg, Germany talks about suppression of telaprevir-resistant hepatitis C variants with combination pegylated interferon and telaprevir treatment. View Abstract 92
In the third presentation, Dr. Paul Pockros, Head, Division of Gastroenterology and Hepatology at Scripps Clinic, LaJolla, California discusses results from a large randomized phase III study of 970 patients with chronic hepatitis C treated with fixed-dose taribavirin, formerly known as viramadine, or weight-based ribavarin plus pegylated interferon alfa 2b. View Abstract 1133 View Abstract 1146
Release Date: November 1, 2006.
Termination Date: November 1, 2007.
Estimated time for completion: 15 minutes.
Robert G. Gish, MD, has received grant/research support from Bayer Pharmaceuticals Corporation, Bristol-Myers Squibb, Eximias Pharmaceutical Corporation, Gilead Sciences, Inc, Hoffmann-La Roche Inc, Idenix Pharmaceuticals Inc, Idun Pharmaceuticals, Inc, InterMune Inc, Ortho Biotech Products, LP, Pfizer Inc, Schering-Plough Corporation, SciClone Pharmaceuticals, Valeant Pharmaceuticals International, and XTL Biopharmaceuticals; is a consultant for Amgen Inc, Anadys Pharmaceuticals, Inc, Bayer Pharmaceuticals Corporation, Bristol-Myers Squibb, Chiron Corporation, Corixa Corporation, Eximias Pharmaceutical Corporation, Gilead Sciences, Inc, GlaxoSmithKline, HepaHope, Inc, Hoffmann-La Roche Inc, Human Genome Sciences, Idenix Pharmaceuticals Inc, Innogenetics, InterMune Pharmaceuticals, Inc, Metabasis Therapeutics, Inc, Nucleonics, Inc, Ortho Biotech Products, LP, Pharmasset Pharmaceuticals Inc, Schering-Plough Corporation, SciClone Pharmaceuticals, United Therapeutics, Valeant Pharmaceuticals International, XTL Biopharmaceuticals, and ZymoGenetics, Inc; and is on the speakers bureau of Bayer Pharmaceuticals Corporation, Bristol-Myers Squibb, Eximias Pharmaceutical Corporation, Gilead Sciences, Inc, GlaxoSmithKline, Hoffmann-La Roche Inc, InterMune Inc, Ortho Biotech Products LP, Schering-Plough Corporation, and Valeant Pharmaceuticals International.
Paul J. Pockros, MD, has received grant/research support from, is a consultant for, and is on the advisory board for Valeant Pharmaceuticals International. Dr. Pockros has disclosed that he will reference the unlabeled or unapproved use of taribavirin.
Stefan Zeuzem, MD, has received grant/research support from, is a consultant for, and is on the speakers bureau of Gilead Sciences, Inc, Idenix Pharmaceuticals Inc, InterMune Inc, Roche Pharmaceuticals, Schering-Plough Corporation, Novartis Pharmaceuticals Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals Incorporated. Dr. Zeuzem has disclosed that he will reference the unlabeled/unapproved use of telaprevir.
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Part 3
Est. download time 56k: 10 min., Broadband: 2 min.
Listen to the third of 4 daily podcasts, which discusses the newest FDA-approved anti-HBV agent and two promising investigational drugs for the treatment of HCV.
In the third installment of Newsmakers In Medicine, the Hepatology Edition, Drs. Lai and Di Bisceglie discuss the use of the newly approved nucleoside analog telbivudine as treatment for hepatitis B virus infection, and Drs. Dietrich and Jacobson discuss investigational agents for the treatment of hepatitis C virus infection, namely valopacitabine and CPG 10101, a specific immunomodulatory agent.
In the first presentation, Dr. Chin-Lung Lai, Professor of Medicine and Hepatology, Department of Medicine, at University of Hong Kong Queen Mary Hospital Hong Kong, China discusses 2-year results from the phase III GLOBE trial comparing telbivudine and lamividine in patients with chronic hepatitis B virus infection. On October 25, the Food and Drug Administration (FDA) approved telbivudine for the treatment of adults with chronic hep B virus infection based largely on the strength of the findings from the GLOBE trial. View Abstract 112
In the second presentation, Dr. Adrian Di Bisceglie, Professor of Internal Medicine Chief of Hepatology, at Saint Louis University School of Medicine discusses the predictive value of early suppression of hepatitis B virus with telbivudine or lamivudine on efficacy outcomes at 2 years using data from the large phase III GLOBE trial. The data are consistent with previous studies showing a relationship between the magnitude of early viral suppression with antiviral nucleosides and subsequent efficacy outcomes, and suggest new treatment paradigms for chronic hep B virus infection. View Abstract 93
In the third presentation, Dr. Douglas Dieterich, Professor of Medicine, Director, Continuing Medical Education, at Mount Sinai School of Medicine, New York, New York talks about 24-week results from an ongoing phase IIb trial evaluating valopicitabine, also known as NM283, plus pegylated interferon in treatment-naive hep C patients with genotype-1 infection. Valopicitabine is an orally bioavailable prodrug that targets the virus-encoded RNA polymerase that is responsible for synthesizing viral RNA during replication. View Abstract 992
In the final presentation, Dr. Ira M. Jacobson, Chief, Division of Gastroenterology and Hepatology, Medical Director of the Center for the Study of Hepatitis C, at Weill Medical College of Cornell University, New York, New York discusses early results from a clinical trial evaluating CPG 10101 in patients infected with hep C genotype-1 who were nonresponders to prior peginterferon plus ribavirin treatment. CPG 10101 is an investigational TLR9 or Toll-like receptor 9 agonist and an example of specific immunomodulatory agents being evaluated as potential treatment for chronic hepatitis. View Abstract 96
Release Date: November 2, 2006.
Termination Date: November 2, 2007.
Estimated time for completion: 15 minutes.
Adrian M. Di Bisceglie, MD, FACP
, has received grant/research support from Gilead Sciences, Inc, Idenix Pharmaceuticals Inc, Roche Pharmaceuticals, SciClone Pharmaceuticals, Schering-Plough Corporation, and Vertex Pharmaceuticals Incorporated; is a consultant for Abbott Laboratories, Bristol-Myers Squibb Company, Chiron Corporation, and SciClone Pharmaceuticals; is on the speakers bureau of Bristol-Myers Squibb Company, Gilead Sciences, Inc, Roche Pharmaceuticals, and Schering-Plough Corporation; is a member of advisory boards for Bristol-Myers Squibb Company, Idenix Pharmaceuticals, Inc, Novartis Pharmaceuticals Corporation, Roche Pharmaceuticals, and Vertex Pharmaceuticals Incorporated; and is a member of Data Safety Monitoring Board for Schering-Plough Corporation.
Douglas T. Dieterich, MD
, has received grant/research support from, is a consultant for, is on the speakers bureau of, has served on advisory boards for, and has received honoraria from Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, Inc, Idenix Pharmaceuticals, Novartis Pharmaceuticals Corporation, and Roche Pharmaceuticals. Dr. Dietrich has disclosed that he will discuss the unlabeled or unapproved use of NM-283 with peginterferon for the treatment of HCV.
Ira M. Jacobson, MD
, has received grant/research support from Bristol-Myers Squibb Company, Coley Pharmaceuticals, Gilead Sciences, Inc, GlobeImmune, Idenix Pharmaceuticals, InterMune Inc, Novartis Pharmaceuticals Corporation, Schering-Plough Corporation, Valeant Pharmaceuticals, and Vertex Pharmaceuticals, Inc; is a consultant for Anadys Pharmaceuticals, Inc, Bristol-Myers Squibb Company, Celera Genomics, Coley Pharmaceuticals, Gilead Sciences, Inc, Idenix Pharmaceuticals, InterMune Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Schering-Plough Corporation, Valeant Pharmaceuticals, and Vertex Pharmaceuticals, Inc; and is on the speakers bureaus of Bristol-Myers Squibb Company, Gilead Sciences, Inc, and Schering-Plough Corporation.
Ching-Lung Lai, MD
, has received grant/research support from Anadys Pharmaceuticals, Inc, Bristol-Myers Squibb, Idenix Pharmaceuticals Inc, LG Life Sciences, Ltd, and Novartis Pharmaceuticals Corporation.
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Part 4
Est. download time 56k: 10 min., Broadband: 2 min.
Listen to the fourth and final daily podcast, which focuses on resistance issues related to HBV, follow-up therapy for patients treated with a triple-agent regimen for HCV, and the impact of weight-based dosing of anti-HCV agents for specific patient subpopulations.
In the fourth installment of Newsmakers In Medicine, Hepatology Edition, Dr. Pietro Lampertico talks about the use of adefovir plus lamividine treatment in hepatitis B patients with demonstrated resistance to lamividine, Dr. McHutchison discusses follow-up treatment with peginterferon and ribavirin in hepatitis C patients previously treated with telaprevir/peginterferon/ribavirin triple therapy, and Dr. Jacobson describes the impact of weight-based dosing of peginterferon and ribavirin in subgroups of hepatitis C patients commonly seen in clinical practice, namely Hispanic, obese, and elderly patients.
Dr. Pietro Lampertico Doctor, Gastroenterology Unit, University of Milan, Milan, Italy discusses two studies looking at combination therapy with adefovir and lamividine in lamividine-resistant hepatitis B patients. One study examines whether adefovir-lamividine combination therapy is superior to adefovir monotherapy in this patient population, and the other discusses the development of genotypic resistance to adefovir after 3 years of combination treatment. View Abstract 989 View Abstract LB5
In the third presentation, Dr. John G. McHutchison, Director, Gastroenterology and Hepatology Research, Duke Clinical Research Institute, Professor of Medicine, Duke University Medical Center, Durham, North Carolina talks about preliminary results from an ongoing clinical trial examining follow-up therapy with pegylated-interferon and ribavirin in patients with chronic hepatitis C infection after 28-day treatment with telaprevir plus pegylated-interferon and ribavirin. Telaprevir is an orally administered, highly selective inhibitor of the hep C virus NS3-4A protease required for viral replication. View Abstract 927
In this next segment, Dr. Ira M. Jacobson, Chief, Division of Gastroenterology and Hepatology, Medical Director of the Center for the Study of Hepatitis C, at Weill Medical College of Cornell University, New York, New York discusses three subanalyses of data acquired from the large, WIN-R trial of weight-based dosing of pegylated-interferon alfa 2b and ribavirin in patients with chronic hep C virus infection. The subanalyses examined the impact of therapy in Hispanic versus other racial or ethnic populations, in patients weighing 125 kg or more versus those weighing less than 125 kg, and in patients older than 65 years of age versus other age groups. View Abstract 369 View Abstract 349 View Abstract 338
Release Date: November 3, 2006.
Termination Date: November 3, 2007.
Estimated time for completion: 15 minutes.
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Closing comments from Dr. Bruce Bacon
Est. download time 56k: 10 minutes,
Broadband: 2 min.
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Ira M. Jacobson, MD, has received grant/research support from Bristol-Myers Squibb Company, Coley Pharmaceuticals, Gilead Sciences, Inc, GlobeImmune, Idenix Pharmaceuticals, InterMune Inc, Novartis Pharmaceuticals Corporation, Schering-Plough Corporation, Valeant Pharmaceuticals, and Vertex Pharmaceuticals, Inc; is a consultant for Anadys Pharmaceuticals, Inc, Bristol-Myers Squibb Company, Celera Genomics, Coley Pharmaceuticals, Gilead Sciences, Inc, Idenix Pharmaceuticals, InterMune Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Schering-Plough Corporation, Valeant Pharmaceuticals, and Vertex Pharmaceuticals, Inc; and is on the speakers bureaus of Bristol-Myers Squibb Company, Gilead Sciences, Inc, and Schering-Plough Corporation.
Pietro Lampertico, MD, is on the speakers bureau of Gilead Sciences, Inc, Idenix Pharmaceuticals, Novartis Pharmaceuticals Corporation, and Roche Pharmaceuticals; and has served on advisory boards for Gilead Sciences, Inc, Idenix Pharmaceuticals, and Novartis Pharmaceuticals Corporation.
John G. McHutchison, MD, FRACP, has received grant/research support from Akros Pharma Inc, Amgen Inc, Bayer Pharmaceuticals, Biomedicines, Bristol-Myers Squibb Company, Coley Pharmaceuticals, Inc, Fujisawa Healthcare, Inc, Gilead Sciences, Inc, Human Genome Sciences, IDUN Pharmaceuticals, Isis Pharmaceuticals, Inc, Ortho Diagnostic Systems, Inc, Prometheus Laboratories, Ribozyme Pharmaceuticals, Inc, Roche Pharmaceuticals, Schering-Plough Corporation, SciClone Pharmaceuticals, Triangle Pharmaceuticals Inc, and Vertex Pharmaceuticals, Inc; and is a consultant for and/or on the speakers bureaus and advisory boards of Amgen Inc, Anadys Pharmaceuticals, Inc, Centocor, Inc, Coley Pharmaceuticals, GlaxoSmithKline, Idenix Pharmaceuticals, Inc, InterMune Inc, Isis Pharmaceuticals, Inc, National Genetics Institute Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Prometheus Laboratories, Ribozyme Pharmaceuticals, Inc, Schering-Plough Corporation, Valeant Pharmaceuticals, Vertex Pharmaceuticals, Inc, and XTL Biopharmaceuticals Ltd.
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Daily Podcasts on HBV and HCV: News and Views from the 2006 Meeting in Boston, a series of four lively 15-minute podcasts, features commentary by top gastroenterology and hepatology experts recorded onsite at the 2006 annual liver meeting in Boston. In four daily installments spanning October 31 to November 3, these leading experts provide insights on the latest clinical studies and scientific advances related to HBV and HCV and also discuss some of the presentations and poster sessions from the meeting.
These podcasts are available as streaming audio or can be downloaded to a computer or MP3 player. You can earn CME/CE credit by taking the posttest following each day's posting.
Estimated time for completion of this activity: 1 hour (15 minutes for each posting)
CME/CE Instructions:
To receive CME/CE credit for your participation in this CME/CE activity,
please complete the following steps:
- Participate in this online activity by listening to any or all of the audio podcasts.
- Complete the CME/CE Posttest following each podcast, selecting the most appropriate response to each question.
- Complete the CME/CE Evaluation.
- Instantly access and print out your certificate.
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