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  • ACCP 2018 Journal CE: The Journal of Clinical Pharmacology Monthly CE Offerings

    Contains 35 Component(s), Medical Credits Offered

    ACCP's The Journal of Clinical Pharmacology (JCP) monthly Journal CE Offerings. Each month, an article selected by the Editor-in-Chief is available for CE credit.

    Welcome to ACCP's The Journal of Clinical Pharmacology (JCP) monthly CE Offerings.
    Each month, an article selected by the Editor-in-Chief is available for CE credit.

    Instructions and Pricing

    JCP Journal CE articles are priced in packages of Jan - Dec for each year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once you register, you have access to all of the articles for the calendar year. If you have an ACCP profile, make sure you have signed in to the ACCP website and then register by clicking the green register button at the top right.

    Requirements for Completion

    Once you have registered, you can access the articles under the Article tab above. The post-event test and evaluation are accessed in your dashboard to the right. CE Certificates are available after the learner has completed the self-assessment and the evaluation. You must print your CE Certificate in order to receive CE credit. CPE data is uploaded into the CPE Monitor at the beginning of the following month.

    Registration Assistance

    If you have any difficulty registering or do not have an ACCP profile, one must be created before you can register for Journal CE articles. If you do not know if you have a profile, please contact KLevy@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to ce@ACCP1.org  

    Accreditation Statements

    The American College of Clinical Pharmacology (ACCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    The American College of Clinical Pharmacology (ACCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.


    Disclosure Information


    Please see this activities individual, monthly announcements under the "Articles" tab for all other disclosure information related to this educational activity.  




     

  • ACCP 2018 Annual Meeting SYMPOSIA Self-assessment & CE Certificates

    Contains 36 Component(s), Medical Credits Offered

    Thank you for attending the 2018 ACCP Annual Meeting! Please complete the Survey Monkey course evaluation for each course you attended and then return to this page to complete a self-assessment (self-correcting test) of your post-course knowledge. After completing the self-assessment, be sure to claim and print your certificate for the course! As with any educational event, please only complete self-assessments and claim certificates for the course which you attended. Credits must be claimed by October 31, 2018.

    The 2018 Annual Meeting Self-assessment & CE Certificates program is available only to those registered and attended the 2018 ACCP Annual Meeting. Please follow the individual course links in the ACCP mobile app or in your attendee emails to complete your course evaluations (in Survey Monkey) and then return to this page to complete a self-assessment (self-correcting test) of your post-course knowledge. There is no minimum score to pass so please this this as a personal challenge to test yourself! After completing the self-assessment, be sure to claim and print your certificate for the course!  As with any educational event, please only complete self-assessments and claim certificates for the courses which you attended.

    Credits must be claimed by October 31, 2018!

    The results of your self-assessment will be compared with the Pre-meeting Self-assessment many of you took to identify whether or not the Annual Meeting courses resulted in a change in attendees knowledge and if there are areas where future education efforts should be focused.

    If you are a US licensed Pharmacists and have never previously claimed ACPE credits with ACCP, please also email us at CE@ACCP1.org and provide your NAPB number and MM/DD of birth so we can report your credits to the CPE Monitor. Without your NABP and MM/DD we will be unable to report your credits earned.

    If you have any questions or difficulty, please contact CE@ACCP1.org or call the Director of Education at (571) 291-3493 ext 2.

    AM2018 Annual Meeting Self-assessment & Certificates

    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    ACCME Designation Statement

    The Accreditation Council for Continuing Medical Education designates this enduring material CE activity for AMA PRA Category 1TM credits based upon participation. Physicians should only claim credit commensurate with the extent of their participation in the activity. See Final Program

    Target Audience

    Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and Physician Assistants who are registered to attend the ACCP 2018 Annual Meeting.

    Learning Objectives

    See Final Program

    Acknowledgement of Financial Support

    See Final Program

    Date of Issuance:  9/23/2018

    Expiration Date:   10/31/2018 


  • ACCP 2018 Annual Meeting WORKSHOPS Self-assessment & CE Certificates

    Contains 8 Component(s), Medical Credits Offered

    Thank you for attending the 2018 ACCP Annual Meeting Pre-meeting Workshop(s)! Please complete the Survey Monkey course evaluation for each workshop you attended and then return to this page to complete a self-assessment (self-correcting test) of your post-course knowledge. After completing the self-assessment, be sure to claim and print your certificate for the course! As with any educational event, please only complete self-assessments and claim certificates for the workshops which you attended. Credits must be claimed by October 31, 2018.

    The 2018 Annual Meeting Pre-meeting Workshops Self-assessment & CE Certificates program is available only to those registered and attended the 2018 ACCP Annual Meeting. Please follow the individual course links in the ACCP mobile app or in your attendee emails to complete your workshop evaluations (in Survey Monkey) and then return to this page to complete a self-assessment (self-correcting test) of your post-course knowledge. There is no minimum score to pass so please this this as a personal challenge to test yourself! After completing the self-assessment, be sure to claim and print your certificate for the workshop!  As with any educational event, please only complete self-assessments and claim certificates for the workshop(s) which you attended.

    Credits must be claimed by October 31, 2018!

    The results of your self-assessment will be compared with the Pre-meeting Self-assessment many of you took to identify whether or not the Annual Meeting workshops resulted in a change in attendees knowledge and if there are areas where future education efforts should be focused.

    If you are a US licensed Pharmacists and have never previously claimed ACPE credits with ACCP, please also email us at CE@ACCP1.org and provide your NAPB number and MM/DD of birth so we can report your credits to the CPE Monitor. Without your NABP and MM/DD we will be unable to report your credits earned.

    If you have any questions or difficulty, please contact CE@ACCP1.org or call the Director of Education at (571) 291-3493 ext 2.

    AM2018 Annual Meeting Pre-meeting Workshops Self-assessment & Certificates

    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    ACCME Designation Statement

    The Accreditation Council for Continuing Medical Education designates this enduring material CE activity for AMA PRA Category 1TM credits based upon participation. Physicians should only claim credit commensurate with the extent of their participation in the activity. See Final Program

    Target Audience

    Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and Physician Assistants who are registered to attend the ACCP 2018 Annual Meeting.

    Learning Objectives

    See Final Program

    Acknowledgement of Financial Support

    See Final Program

    Date of Issuance:  9/23/2018

    Expiration Date:   10/31/2018 

  • ACCP 2018 Virtual Journal Club September: Prednisone Pharmacokinetics During Pregnancy and Lactation - On Demand

    Contains 5 Component(s), Medical Credits Offered Recorded On: 09/19/2018

    Presented by: Mary F. Herbert, PharmD, FCP, FCCP, Professor of Pharmacy and Adjunct Professor of Obstetrics & Gynecology, University of Washington. Learners that complete this course will be able to describe the movement of prednisone and its metabolite prednisolone in the body of females during various stages of pregnancy and lactation including infant exposure to these agents via breast milk.

    Prednisone Pharmacokinetics During Pregnancy and Lactation - On Demand

    ACCP Virtual Journal Club Webinars

    On Demand: Starting September 20, 2018


    Why is this webinar important to you? 

    Learners that complete this course will be able to describe the movement of prednisone and its metabolite, prednisolone, in the body of females during various stages of pregnancy and lactation, including infant exposure to these agents via breast milk.

    Target Audience

    Interprofessional team of physicians, pharmacists, PhDs, nurse practitioners and physician assistants. 

    Learning Objectives

    After completing this activity, the learner will be able to:

    • Describe the metabolism of prednisone and prednisolone via interconversion;
    • Discuss if prednisone and prednisolone undergo dose-dependent pharmacokinetics during pregnancy;
    • Discuss if prednisone and prednisolone undergo concentration-dependent pharmacokinetics during pregnancy;
    • Interpret that infant exposure to prednisone and prednisolone via breast milk is minimal.

    Requirements to Receive Credit

    In order to receive CE credit, the learner must register for the educational activity, study the provided journal article, attend the Live webinar or view the on-demand webinar, complete the online learning self-assessment (post-test), complete the online course evaluation and print the certificate.


    See CE Info tab for more information on CME and CPE credits.


    Mary Hebert, PharmD, FCCP

    Professor of Pharmacy & Adjunct Professor of OB/GYN, Univ of Washington

    Mary F. Hebert, Pharm.D., FCCP is a Professor of Pharmacy, Adjunct Professor of OBGYN, Director of the University of Washington Obstetric-Fetal Pharmacology Research Unit, Core Member of the Univ of Washington, Ctr for Ecogenetics and Environmental Health and Member of the Univ of Washington Inst of Translational Health Sciences. She completed her PharmD, residency and post-doctoral training at the Univ of California, San Francisco. Dr. Hebert joined the Univ of Washington Faculty in 1996 after serving on the Clinical Faculty at the Univ of California, San Francisco for 6 years. She has a long-standing, well-funded, productive research program and has been an invited speaker at many national and international conferences. Her research focuses on a mechanistic understanding of changes in the clinical pharmacology of medications during pregnancy and lactation. Dr. Hebert has more than 30 years experience conducting clinical pharmacology research resulting in over 100 publications.

    Joseph D. Ma, PharmD, FCP (Moderator)

    Professor, Skaggs School of Pharmacy & Pharmaceutical Sciences, Univ of California San Diego, Div of Clinical Pharmacy

    Joseph D. Ma, PharmD, FCP is Professor in the Division of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences, Univ of California San Diego.  He completed his Pharmacy Doctorate at Univ of California, San Francisco and a clinical pharmacology fellowship at Bassett Healthcare, Cooperstown, NY. His current research interests are evaluating in vivo drug metabolizing enzyme activity and opioid pharmacokinetic variability.  His current clinical practice is the Doris A. Howell Pain and Palliative Care Service at UC San Diego  specializing in symptom management.  Under a collaborative practice agreement he is able to assess, initiate, stop, and/or adjust therapy for the management of pain and other physical symptoms with independent prescriptive authority.  

    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

    UAN: 0238-0000-18-037-L/H01-P– ACPE 1 Contact Hours

    Activity Type:  Knowledge-based   Format: Live & Home-study   Target Audience: ‘P’

    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    ACCME Designation Statement

    The Accreditation Council for Continuing Medical Education designates this live and enduring CE activity for 1 AMA PRA Category 1TM credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.


    Requirements to Receive Credit

    In order to receive CE credit, the learner must register for the educational activity, study the provided journal article, attend the Live webinar or view the on-demand webinar, complete the online learning self-assessment (post-test), complete the online course evaluation and print the certificate.

    Online Location: How to Print CE Certificates

    https://accp1.org/documents/CommPartners/ReprintCECertificates.pdf


    Disclosures: 

    Author/Faculty:   Mary F. Hébert, PharmD, FCCP, Professor of Pharmacy and Adjunct Professor of Obstetrics & Gynecology, University of Washington, has nothing to disclosure related to this topic.

     Moderator/CE Planner:  Joseph D. Ma, PharmD, FCP, Professor, Skaggs School of Pharmacy & Pharmaceutical Sciences,Univ of California San Diego, Div of Clinical Pharmacology, has nothing to disclose related to this topic.

     Reviewer:   Francis Achike, MD, PhD, MEd, Professor of Pharmacology, Anesthesiology & Clinical Skills, California Univ of Science & Medicine, has nothing to disclose.


    Schedule & Fees

    The ACCP webinar programs occur several times per year. Registration for the webinars are required but are free of charge to all learners.

    Acknowledgement of Financial Support

    No financial support was received for this educational activity.


    Home Study Initial Release and Expiration Dates

    Date of Issuance: September 19, 2018

    Expiration Date: September 19, 2021

  • ACCP 2018 Virtual Journal Club August - Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended‐Release Once‐Daily Tacrolimus Tablets

    Contains 5 Component(s), Medical Credits Offered

    Presented by: Timothy Horwedel, MHA, PharmD, BCPS and Patricia West-Thielke, PharmD. This webinar will assist learners to evaluate and apply a flexible tacrolimus concentration monitoring approach in the management of kidney transplant patients receiving extended-release once-daily tacrolimus tablets that allows for an extended therapeutic monitoring window based upon utilization of formulas and tools for interpreting drug levels within the expanded window.

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    Attendees Obtain Free CE Credits from ACCP Virtual Journal webinars!

    Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended‐Release Once‐Daily Tacrolimus Tablets

    ACCP 2018 Virtual Journal Club Webinars

    Live Session: Wednesday, August 8, 2018 from 2:00pm to 3:00pm ET

    On Demand: August 8, 2018 to August 8, 2021

    Why is this webinar important to you? 

    Learners that complete this course will be able to evaluate and apply a flexible tacrolimus concentration monitoring approach in the management of kidney transplant patients receiving extended‐release once‐daily tacrolimus tablets that allows for an extended therapeutic monitoring window based upon utilization of formulas and tools for interpreting drug levels within the expanded window.


    image

    ACPE Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

    UAN: 0238-0000-18-035-L/H01-P– ACPE 1 Contact Hours

    Activity Type:  Knowledge-based   Format: Live & Home-study   Target Audience: ‘P’

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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    ACCME Designation Statement

    The Accreditation Council for Continuing Medical Education designates this live and enduring CE activity for 1 AMA PRA Category 1TM credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.


    Target Audience

    Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and Physician Assistants.

    Learning Objectives

    After completing this activity, the learner will be able to:

    • Compare the different pharmacokinetic profiles of immediate release and extended-release once-daily tacrolimus formulations;
    • Describe the correlations between tacrolimus concentrations around trough levels and the overall exposure (plasma drug concentration curve/AUC) over a dosing interval;
    • Interpret non-standard tacrolimus concentration monitoring results and apply these approaches to dosage monitoring/adjustments plans in patients.

    Requirements to Receive Credit

    In order to receive CE credit, the learner must register for the educational activity, study the provided journal article, attend the Live webinar or view the on-demand webinar, complete the online learning self-assessment (post-test), complete the online course evaluation and print the certificate.

    Disclosures: 

    • Author/Faculty:   Timothy Horwedel, MHA, PharmD, BCPS, Transplant Clinical Specialist, Barnes-Jewish Hosp, Dept of Pharmacy, reports a relevant financial relationship (honoraria, grant support) with Veloxis Pharmaceuticals. An independent content review has been completed which finds the article and presentation to be evidence-based, unbiased and non-promotional in nature.
    • Author/Faculty:   Patricia West-Thielke, PharmD, Director of Clinical Transplant Research, Univ of Illinois, Dept of Surgery, reports relevant financial relationships (honoraria, grant support) with Veloxis Pharmaceuticals and Astellas Pharma US. An independent content review has been completed which finds the article and presentation to be evidence-based, unbiased and non-promotional in nature.
    • Moderator/CE Planner:  Parag Kumar, PharmD, Associate Director Clinical Pharmacology, Otsuka America Pharmaceuticals, has nothing to disclose related to this topic.
    • CE Content Reviewer:   Sandeep Kushal, MBBS, MD, Professor and Head, Dayanand Medical College and Hosp, Dept of Pharmacology, has nothing to disclose.

    Schedule & Fees

    The ACCP webinar programs occur several times per year. Registration for the webinars are required but are free of charge to all learners.

    Acknowledgement of Financial Support

    No financial support was received for this educational activity.

    Home Study Initial Release and Expiration Dates

    Date of Issuance: August 8, 2018

    Expiration Date: August 8, 2021

    Online Location: https://accp1.org/Members/Cont...


    ACCP is a Member-focused/Member-driven clinical pharmacology society with

    Member Benefits that enhance your professional growth. Join today!


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    Timothy Horwedel, MHA, PharmD, BCPS

    Clinical Pharmacy Specialist, Barnes-Jewish Hosp

    Timothy Horwedel, MHA, PharmD, BCPS, received his PharmD from Northeastern Univ in 2008, then completed a PGY1 residency at Henry Ford Hosp, followed by a PGY2 in Solid Organ Transplantation at Barnes-Jewish Hosp. Following training, he served first as a clinical specialist in liver, kidney, and pancreas transplant from 2010 – 2012 at Univ of Michigan. Since 2012, he has been a clinical specialist in liver, kidney, and pancreas transplant at Barnes-Jewish Hosp, as well as serving as transplant supervisor and PGY1 residency program director. He holds an appointment of Adjunct Experiential Assistant Professor with the St. Louis Coll of Pharmacy as well as an appointment as an Adjunct Instructor with Washington Univ School of Medicine.

    Patricia West-Thielke, PharmD

    Director of Clinical Transplant Research, Univ of Illinois, Dept of Surgery

    Dr. Patricia West-Thielke, PharmD, is the Director of Clinical Transplant Research and Research Assistant Professor of Surgery at the Univ of Illinois Hosp and Health Sciences System. She has  been the principal investigator for over 30 kidney transplant clinical trials and manages a clinical trials unit. She is actively involved with the transplant program educating patients in both the pre- and post-transplant phases. Her areas of research include adherence, pharmacokinetics and sensitization .  

    Parag Kumar, PharmD (Moderator)

    Associate Director, Otsuka Pharmaceutical America, Dept of Clinical Pharmacology

    Dr. Parag Kumar, PharmD, graduated with a Doctorate in Pharmacy Summa Cum Laude from the Univ of Georgia Coll of Pharmacy, and then completed a two-year Clinical Research and Drug Development Fellowship at the Univ of North Carolina Chapel Hill and United Therapeutics Corporation (Durham, NC).  Dr. Kumar is currently an Associate Director, Clinical Pharmacology at Otsuka American Pharmaceutical, Inc. (Rockville, MD).  Previously he served as the Director of the Clinical Pharmacokinetics Research Unit (CPRU) of the National Institutes of Health (NIH), Clinical Center Pharmacy Department. In his role as director of the CPRU, Dr. Kumar has been a principal investigator or lead investigator on several clinical studies at the NIH evaluating the potential for drug interactions between HIV medications and other medications that may be used in this population. In addition to HIV, Dr. Kumar has collaborated as an associate investigator in several clinical research investigations including studies of drug metabolism/transport, drug-drug interactions, drug-gene interactions, and dose-escalation/dose-safety/tolerability in various rare/orphan disease states at the NIH. 

  • ACCP 2018 Webinar: How to be a Great Journal Peer Reviewer

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Joseph S. Bertino Jr., PharmD, FCP, FCCP, Editor-in-Chief, The Journal of Clinical Pharmacology and David J. Greenblatt MD, FCP, Editor-in-Chief Clinical Pharmacology in Drug Development. This webinar provides professional training on performing scientific journal manuscript peer reviews.

    ACCP 2018 Webinar - How to be a GREAT Journal Peer Reviewer

    Live webinar with the Editor-in-Chiefs: June 13, 2018   2:00 – 3:00 PM ET  

    On-demand webinar recording:  June 13, 2018 to June 13, 2021

    Why is this article important to your practice? 

    At the completion of this webinar participants will have a strong understanding and the skills to properly review a scientific manuscript, a professional competency applicable to journal peer reviewing across professions. Topics to be covered include: why one should serve as peer reviewer; the purpose of manuscript reviews; aspects of a great review; when to decline a review; confidentiality; a technical guide for reviews for each section of the manuscript; and writing the review.  

    Target Audience: 

    Researchers, Physicians, Pharmacists, and other professionals requiring training in the professional competencies of peer reviewing. 

    Learning Objectives: 

    After completing this activity, the learner will be able to:

    1. Describe why the peer review process is important;
    2. Explain how to review various sections of a scientific manuscript;
    3. Identify elements of writing a review that will be of benefit to the authors and to the Editor of the Journal.

    To receive full credit, learners must attend the complete live webinar or view the complete on-demand webinar; pass a post-course assessment with 75% or greater and complete an evaluation.


    Joseph S. Bertino Jr., PharmD, FCP, FCCP

    Editor-in-Chief The Journal of Clinical Pharmacology

    Joseph S. Bertino Jr., Pharm.D., FCP, FCCP, is currently a Principal at Bertino Consulting, located in Schenectady, NY.  He is an Associate Professor of Pharmacology at the College of Physicians and Surgeons, Columbia University, New York, NY and an adjunct Associate Professor at the University at Buffalo School of Pharmacy.  He is also an Honorary Professor, Hanoi University of Pharmacy and a Distinguished Professor of the Hai Phong University of Medicine and Pharmacy.

    Dr. Bertino received his B.S.Pharmacy and Pharm.D. degrees from the University at Buffalo in Buffalo, NY, USA.  He has published over 100 original research papers, review articles and book chapters and a textbook of pharmacogenomics. His publications have included work in the area of antimicrobial pharmacokinetics, pharmacodynamics and toxicity, drug-drug interactions, general clinical pharmacology, vaccine pharmacology and the application of pharmacogenetics and pharmacogenomics to the drug development process.

    He serves on the Editorial Board of The European Journal of Clinical Pharmacology and Antimicrobial Agents and Chemotherapy.  Dr. Bertino has served on the Food and Drug Administration’s Antiinfective and Antiviral Advisory Committees.  He also serves as the Editor-in-Chief of the Journal of Clinical Pharmacology.

     

    David J. Greenblatt MD, FCP

    Editor-in-Chief Clinical Pharmacology in Drug Development

    Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine and the Staff of Tufts Medical Center since 1979.  He holds the Louis Lasagna, M. D., Endowed Professorship at Tufts University School of Medicine, in the Department of Immunology (formerly the Department of Pharmacology and Experimental Therapeutics), and is a senior faculty member in the Graduate Program in Pharmacology & Experimental Therapeutics at the Sackler School of Graduate Biomedical Sciences at Tufts University. He also holds appointments as Professor of Psychiatry, Medicine, and Anesthesia, Tufts University School of Medicine.  He has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine, Program Director and Associate Program Director of the institution’s Clinical/Translational Research Center (formerly the General Clinical Research Center), and Chair of the Institutional Review Board. He is Editor-in-Chief of Clinical Pharmacology in Drug Development, operated by the American College of Clinical Pharmacology.  He also is Co-Editor-in-Chief, with Dr. Richard I. Shader, of the Journal of Clinical Psychopharmacology,

     

    A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966), where he was senior class president and co-captain of the varsity football team. After college he attended Harvard Medical School, graduating in 1970.  Thereafter he trained in internal medicine at the Montefiore Hospital, New York City (1970-1971), and on the Harvard Medical Service at Boston City Hospital (1971-1972).  Following a Fellowship in Clinical Pharmacology at Massachusetts General Hospital under the mentorship of Dr. Jan Koch-Weser (1972-1974), he stayed on to head the Clinical Pharmacology Unit at Mass. General from 1975 to 1979, at which time he moved to Tufts.

    Joan Korth-Bradley, PharmD, PhD, FCP (Moderator)

    Senior Director, Clinical Pharmacology, Pfizer Inc.

    Joan Korth-Bradley is Senior Director, Clinical Pharmacology at Pfizer Inc where she has worked since 1991.  She received her B.Sc.Phm. from the University of Toronto, her Pharm.D. from the University of Minnesota and her Ph.D. from the University of Texas at Austin.  She also completed a residency in hospital pharmacy at the Ottawa General Hospital and a post-PharmD fellowship in pediatric clinical pharmacy at the University of Texas at Austin/Brackenridge Hospital, Austin.  She serves on the editorial board of the Clinical Pharmacology and Therapeutics, Clinical and  Translational Science, and the Journal of Clinical Pharmacology.  Joan also serves as a peer reviewer for several other clinical therapeutics and pharmacology journals. In addition, she has served as a leader in the American Association of Pharmaceutical Scientists (CPTR Section), American College of Clinical Pharmacy (PK PRN, Industrial Pharmacy PRN), the American College of Clinical Pharmacology (Regent), and the American Society of Clinical Pharmacology and Therapeutics (TPM Network). Her work includes participating as a member of multi-disciplinary development teams working in rare diseases, including hemophilia and growth hormone deficiency.  Previously, she supported anti-infectives and anti-inflammatories as well as life-cycle management activities and market support for a variety of products. Her current research interests are the application of modeling and simulation of pharmacokinetic and pharmacodynamic data in drug development of hemophilia replacement products as well as for drugs in children and other special populations.

  • ACCP 2018 Virtual Journal Club February - Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Manuel Gerónimo-Pardo, MD, PhD, Department of Anesthesiology, Complejo Hospitalario Universitario of Albacete, Spain. This article addresses a new dose form and therapeutic application of acetaminophen in multi-trauma patients.

    ACCP Virtual Journal Club - 2018 Feb - Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration

    Live webinar with the author: February 21, 2018   2:00 – 3:00 PM EST  

    On-demand webinar recording:  February 28, 2018 to February 28, 2021

    Why is this article important to your practice? 

    This article addresses a new dose form and therapeutic application of acetaminophen in multi-trauma patients. 

    Target Audience: Physicians, Pharmacists, and other clinicians involved in treating multi-trauma patients. 

    Goal and Objectives - After completing this activity, the learner will be able to:

    • Describe three potential clinical benefits of acetaminophen in the critically ill patient.
    • List the primary hepatic metabolic routes and the reported renal clearance of acetaminophen.
    • Describe the serum concentrations of acetaminophen needed to provide an antipyretic effect and analgesia.
    • Compare the total daily dose of acetaminophen needed to maintain a serum concentration of 10 ug/ml using multiple dosing and a continuous infusion.  

    To receive full credit, learners must pre-read the article located in the "handouts" tab.

    See Continuing Education Information in the "handouts" tab for more details.


    Manuel Gerónimo-Pardo

    MD, PhD

    Manuel Gerónimo-Pardo, MD, PhD, became a specialist in Clinical Pharmacology at the “Hospital Clínico San Cecilio” of Granada, Spain, in 1998. He worked as a Clinical Pharmacologist first at that hospital and then at the “Complejo Hospitalario Universitario” of Albacete, Spain, for 4 years. While working as a pharmacologist his main field of interest was individualizing the dosage of antibiotics to each patients requirements, based in both pharmacokinetic and pharmacodynamic principles. In 2002 he started a new residence, this time in Anesthesiology, and since 2010 he has been working as an anesthesiologist at the Department of Anesthesiology for the “Complejo Hospitalario Universitario” of Albacete. There he worked some years as an intensive-care physician at the Reanimation Unit, where he could regain his activity adapting drug dosages to patients individual requirements based mainly on renal function. His main activity now, is in the operating theater, but his current field of interest is the development of a new indication for sevoflurane: administration of topical sevoflurane on chronic wounds with analgesic, antimicrobial and pro-healing purposes.

    Brian Decker (Moderator)

    MD, PharmD

    Brian Decker joined the nephrology faculty at the Indiana University School of Medicine in 2007 after completing his nephrology fellowship. Subsequently, Dr. Decker completed a Master’s of Science in clinical research in 2009 and a clinical pharmacology fellowship in 2012 at the Indiana University School of Medicine.  Dr. Decker’s primary clinical and research interests are nephrology, hypertension, clinical pharmacology and the clinical implementation of personalized medicine.  Dr. Decker is also the nephrology fellowship program director and the Clinical Research Center Phase One principal investigator.  In this latter capacity, he oversees the phase one drug studies that are conducted in the Indiana Clinical and Translational Sciences Institute Clinical Research Center.  In his role as an educator, Dr. Decker provides seminars and conferences to clinicians at the intersection of internal medicine, nephrology and personalized medicine.

  • ACCP Virtual Journal Club - Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial

    Contains 4 Component(s), Medical Credits Offered

    Presented by: Susan E. Shoaf, PhD, Otsuka Pharmaceutical Development & Commercialization, Inc.

    ACCP Virtual Journal Club - Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial

    Date: December 13, 2017   2:00 – 3:00 PM ET  

    Why is this article important to your practice? In the pivotal TEMPO 3:4 trial, the arginine vasopressin V2-receptor antagonist tolvaptan reduced the rate of kidney growth in patients with autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan was initiated as daily morning/afternoon doses of 45/15 mg, and uptitrated weekly to 60/30 mg and 90/30 mg according to patient-reported tolerability. Since publication of the TEMPO 3:4 trial, there has been interest in better understanding how this dosing regimen was developed so that the rationale for uptitration to the 90/30-mg dose regimen or to the highest tolerated dose are made in ADPKD patients on tolvaptan.

    The article describes 3 phase 2 trials in adult autosomal dominant polycystic kidney disease subjects that were the basis for the titrated split-dose regimen: a single ascending-dose trial (tolvaptan 15 to 120 mg; n = 11), a multiple split-dose trial (tolvaptan 15/15 mg, 30/0 mg, 30/15 mg, and 30/30 mg; n = 37), and an 8-week open-label safety and efficacy trial in 46 of the 48 subjects who participated in the prior 2 trials (tolvaptan 30/15 mg, 45/15 mg, 60/30 mg, and 90/30 mg). 

    Target Audience: Physicians, Pharmacists, and other clinicians involved in treating ADPKD patients or other renal impairment conditions as well as pharmacologists involved in dose-response and exposure-response safety and efficacy analysis. 

    Goal and Objectives - After completing this activity, the learner will be able to:

    • Understand biomarkers related to vasopressin V2-receptor antagonist efficacy and safety
    • Fully comprehend and explain the PK-PD rationale behind dosing titrations with tolvaptan in ADPKD patients
  • ACCP Virtual Journal Club - Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients

    Contains 4 Component(s), Medical Credits Offered Recorded On: 10/25/2017

    Presented by Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University

    ACCP Virtual Journal Club - Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients

    Wednesday, October 25, 2017; 2:00 – 3:00 PM ET 

    Presented by Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University

    Why is this article important to your practice?
    This article evaluates the role of continuous intravenous lidocaine infusion (IVLI) as an adjunct agent in the management of pain in intensive care unit patients. This article is particularly important for ICU patients who are refractory to opioids or those in whom opioid-induced respiratory depression is a concern as IVLI may lead to a reduction in opioid requirements. This study suggests that IVLI could be a safe and effective adjunctive treatment option for selected ICU patients.

    Target Audience
    Physicians, ICU Nurses, Clinical Pharmacologists and Clinical Pharmacists

    Goal and Objectives
    After completing this activity, the learner will be able to: 

    1. Discuss the indications of IVLI in the management of pain
    2. Analyze the various adverse effects associated with IVLI Describe the limitations of the use of IVLI as an adjunct therapy for pain management in ICU patients


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    Dr. Mo received her PharmD from Creighton University in 2002 and completed a PGY-1 Pharmacy Practice Residency at Barnes-Jewish Hospital in St. Louis, Missouri and a PGY-2 residency in Critical Care at University of Washington Medical Center in Seattle, Washington. After completing residency trainings, she pursued her career as a clinical pharmacy specialist in Surgery/Trauma Intensive Care Unit (ICU) at Cedars-Sinai Medical Center. In the fall of 2016, Dr. Mo joined Long Island University (LIU) Pharmacy as an Associated Professor of Pharmacy Practice. Prior to joining LIU Pharmacy, she taught as an Assistant Professor in the Department of Pharmacy Practice at the Western New England University College of Pharmacy in Springfield, Massachusetts. She also served as an ICU pharmacy specialist at Mercy Medical Center. She is board certified in pharmacotherapy as well as critical care. Her research interests lie in the area of critical care medicine, including pain/sedation/delirium practices, anticoagulation/coagulation management, sepsis, and nosocomial infections. Dr. Mo is currently practicing in the medical ICU and precepting pharmacy students at Brookdale University Hospital and Medical Center in Brooklyn, New York.

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    ACPE Accreditation Statement

    http://accp1.inreachce.com/content/owners/accp1/images/ACPE-black.pngThe American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    ACPE 1 Contact Hours UAN Number: Live:  0238-0000-17-042-LO1-P On Demand: 0238-0000-17-043-H01-P

    Knowledge Based Activity


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    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

     

    Date of Issuance:  10/25/17

    Expiration Date:  10/25/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test; complete an online evaluation and print a certificate.


    Disclosures 

    Presenter: Yoonsun Mo, PharmD, BCPS, BCCCP, Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University has nothing to disclose.

    Moderator: Theodoros Xanthos MD, Pg Dip (Ed), MSc, MRes (EdD), PhD, FHEA, FAcadMEd, FCP, FERC, ERT, FESC, Professor of Medicine European University Cyprus; Professor of Resuscitation, School of Specialties, University of Cagliari, Italy; Professor of Pharmaceutical Sciences (Adjunct) Midwestern University of Chicago who reviewed the activity has no disclosures related to its content.

  • ​ACCP Virtual Journal Club - Prediction of Clearance in Neonates and Infants (≤ 3 Months of Age) for Drugs That Are Glucuronidated: A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling

    Contains 4 Component(s), Medical Credits Offered

    Presented by Iftekhar Mahmood PhD, Division of Clinical Evaluation and Pharmacology/Toxicology Branch, Office of Tissues & Advance Therapies, Center for Biologic Evaluation and Research, US Food & Drug Administration

    ACCP Virtual Journal Club - Prediction of Clearance in Neonates and Infants (≤ 3 Months of Age) for Drugs That Are Glucuronidated: A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling

    Wednesday, August 30, 2017; 2:00 - 3:00 PM ET

    Presented by Iftekhar Mahmood PhD, Division of Clinical Evaluation and Pharmacology/Toxicology Branch, Office of Tissues & Advance Therapies, Center for Biologic Evaluation and Research, US Food & Drug Administation

    Why is this article important to your practice?
    The capacity of drug metabolism in neonates and infants occurs at a much slower rate than adults and is mainly affected by ontogeny of many drug metabolizing enzymes. This article evaluates several allometric and PBPK approaches to predict clearance in neonates (≤3 Months of Age) of nine drugs that undergo glucuronidation. It highlights key physiological factors and allometric exponents that should be considered for acceptable clearance prediction (i.e., ≤ 50% error) for better development of neonatal drugs.

    Target Audience
    Clinical Pharmacologists, Pharmacometricians, DMPK scientists, graduate and postgraduate trainees and pediatricians from academia, industry and regulatory agencies who are interested in neonatal drug development.

    Goal and Objectives
    After completing this activity, the learner will be able to:

    1. Evaluate several allometric and PBPK approaches to predict clearance in neonates (≤3 Months of Age) of nine drugs that undergo glucuronidation
    2. Acknowledge that allometric exponents are not universal and that there is a need to adjust the allometric exponents and incorporate glucuronidation processes for better clearance prediction in different age-groups.
    3. Identify the pros and cons of allometric approaches and how they compare to PBPK approaches to estimate first-in-neonatal dose during drug development.

    image(Author and Presenter) Iftekhar Mahmood, PhD, is a clinical Pharmacologist at the Center for Biologic Evaluation and Research (CBER), FDA.  He holds a Bachelor of Pharmacy degree and a PhD in Pharmaceutical Sciences with specialization in pharmacokinetics.  Dr. Mahmood joined the FDA in December 1993 and for more than eight years served as a clinical pharmacologist dealing with neuro-pharmacology products. In the last ten years, Dr. Mahmood has been a clinical pharmacologist for therapeutic proteins and blood products.  Over the years, Dr. Mahmood has published several papers on the application of allometry to interspecies scaling as well as to pediatric drug development.  Dr. Mahmood has published more than 100 scientific papers in peer-reviewed scientific journals. He is the author of the books Interspecies Pharmacokinetic Scaling, Pediatric Pharmacology and Pharmacokinetics and Pharmacokinetic allometric scaling in pediatric drug development and the editor of the books Clinical Pharmacology of Therapeutic Proteins and Immunogenicity of Therapeutic Proteins.  Dr. Mahmood is the recipient of several CDER Intramural Research Grants as well as the recipient of several CDER and CBER awards.


    image(Moderator) Hazem E. Hassan, PhD is an Assistant Professor of Clinical Pharmacology and Pharmacometrics and Director of the Pharmacokinetics and Biopharmaceutics Laboratory (PBL) at the school of Pharmacy, University of Maryland Baltimore (UMB). His research program is supported by grants from FDA, NIH and NIPTE and focuses on investigating the underlying factors that impact drug development and drug therapy optimization in adults and pre-term neonates via employing in vitro, in vivo and in silico quantitative pharmacology (QP) approaches. Dr. Hassan received several national and international awards including the AAPS award in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism/Clinical Sciences (PPDM/CS), Dr. Ralph Shangraw award, Dr. Arthur Shwartz award, the Egyptian Government General Mission award and was recently selected as the ASCPT Dedicated Member. Dr. Hassan is actively serving on different capacities on several scientific leadership committees including ACCP, ASCPT, AAPS and AACP (i.e., Educational, QP, DDDI and Pharmaceutics, respectively) committees. Dr. Hassan received his doctorate degree (Drug Metabolism and Pharmacokinetics), post-doctoral training (Clinical Pharmacology) and master’s degree (Pharmacometrics) from UMB. He is a registered pharmacist by NABP and a certified controlled dangerous substances researcher by the State of Maryland and the US Department of Justice.  


    Presenter: Iftekhar Mahmood PhD, Div of Hematology Clinical Review, Office of Blood Review & Research, Center for Biologic Evaluation & Research, US Food & Drug Administration, has nothing to disclose.

    Moderator:Hazem Hassan, PhD, MS, RPh, RCDS, Assistant Professor & Director, University of Maryland School of Pharmacy, has nothing to disclose. 

    Reviewer:  Theodoros Xanthos MD, Pg Dip (Ed), MSc, MRes (EdD), PhD, FHEA, FAcadMEd, FCP, FERC, ERT, FESC, Professor of Medicine European University Cyprus; Professor of Resuscitation, School of Specialties, University of Cagliari, Italy; Professor of Pharmaceutical Sciences (Adjunct) Midwestern University of Chicago who reviewed the activity has no disclosures related to its content.

    imageACPE Accreditation Statement

    http://accp1.inreachce.com/content/owners/accp1/images/ACPE-black.pngThe American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. 

    ACPE 1 Contact Hours
    UAN Number:
    Live:  0238-0000-17-037-L01-P
    On Demand: 0238-0000-17-038-H01-P

    Knowledge Based Activity


    image

    ACCME Accreditation Statement

    The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    Designation Statement

    The American College of Clinical Pharmacology designates this journal CE activity for 1 AMA PRA Category 1TM credit.  Physicians should only claim credit commensurate with the extent of the participation in the activity.

    Date of Issuance:  8/30/17
    Expiration Date:  8/30/20

    In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.