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  • Contains 5 Component(s), Includes Credits Includes a Live Web Event on 03/20/2024 at 2:15 PM (EDT)

    Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study.

    2024 ACCP Virtual Journal Club Webinar: Edoxaban Exposure in Patients with Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min - LIVE

    Live Session: Wednesday, March 20th, 2024, from 2:00 to 3:00 PM ET

    On Demand: March 20th, 2024 to March 20th, 2027

    Why is this article important to your practice? 

    There is a lack of clear understanding of high creatinine clearance on pharmacokinetic/pharmacodynamic (PK/PD) outcomes. Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study. 

    Target Audience:

    Interprofessional team of Physicians, Pharmacists, PhDs, and other health care professionals.

    Learning Objectives

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

    • Describe the impact of high creatinine clearance on edoxaban PK and PD and the potential clinical implications;
    • Recognize the utility of population PK modeling in analyzing sparse PK concentrations collected from clinical studies;
    • Describe the key elements of a prospective, randomized, placebo-controlled clinical trial.

     

    Ophelia Yin

    Vice President, Head of Clinical Pharmacology

    iTeos Therapeutics

    Ophelia Yin is currently Vice President, Head of Clinical Pharmacology at iTeos Therapeutics. Ophelia’s career began as Assistant Professor at the Pharmacy School of Chinese University of Hong Kong. She joined Novartis Oncology 2005, serving as the global clinical pharmacology expert to support oncology drug development. From 2012 to 2020, Ophelia was Executive Director and Head of Advanced Pharmacometrics at the Quantitative Clinical Pharmacology Department of Daiichi Sankyo. Her work included development and execution of quantitative clinical pharmacology plans, and use of state-of-the-art pharmacometrics methods to contribute to key decision making at all stages of clinical development across a variety of therapeutic areas, including oncology, cardiovascular and metabolic disease. From 2021 to May 2023, Ophelia was Head of Pharmacometrics at Agios Pharmaceuticals, providing strategic leadership and subject matter expertise to support research and development activities in genetically defined diseases. 

    Ophelia earned a PhD in Pharmaceutics from Shanghai Medical University. She has published over 90 abstracts, 80 peer-reviewed articles, and 2 book chapters in the field of clinical pharmacology and pharmacometrics. Ophelia is a Fellow of American College of Clinical Pharmacology, and a member of editorial board of Journal of Clinical Pharmacology.

    Dr. Yin is an employee of iTeos Therapeutics. All of the relevant financial relationships for this individual have been mitigated

    Stefanie Drescher

    Manager, Clinical Pharmacology

    Pfizer Inc

    Dr. Stafanie Drescher is an accomplished Pharmacist, Quantitative Clinical Pharmacologist, and Clinical Pharmacology Leader with over 8 years of comprehensive experience in Translational Medicine & Early Clinical Development working in the biopharmaceutical sector, regulatory bodies (U.S. Food and Drug Administration), and academia. Actively promoting the implementation of model-informed drug development (MIDD) principles to ensure swift and effective transition of new therapeutics from the laboratory to the patient's bedside. Regularly collaborate within multidisciplinary teams on innovative early-stage oncology programs.

    Experienced across all stages of drug development, encompassing the design, management, and analysis of both preclinical and clinical studies, such as xenograft and syngeneic tumor models, first-in-human investigations in healthy volunteers and cancer patients (Phase I/II trials), clinical DDI, relative BA, BE, IVIVC, food effect, special populations, and QTc. Broad therapeutic knowledge in infectious diseases, oncology, and respiratory diseases.

    Stefanie Drescher is an employee of Pfizer Inc.  All of the relevant financial relationships for this individual have been mitigated.

  • Contains 12 Component(s), Includes Credits

    The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.

    Registration and Pricing

    The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.

    To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.

    Requirements for Credits

    All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated in their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.

    CE Expiration 12/31/2027




     

  • Contains 48 Component(s), Includes Credits

    The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.

    Registration and Pricing

    The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.

    To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.

    Requirements for Credits

    All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated into their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.

    CE Expiration 12/31/2026




     

  • Contains 1 Component(s)

    This 60 minute webinar will explain the assessment of transporter-medicated DDIs using exogenously-administered probe drugs and discuss pros/cons of various probe cocktails.

    2023 ACCP Webinar: From Exogenous Probes to Endogenous Biomarkers: A Paradigm Shift in the Approach to Assess Transporter Mediated Drug-Drug Interactions - ON DEMAND

    Why is this Webinar important to you?

    Membrane bound drug transporters, expressed in various tissues throughout the body, control the movement of endogenous and exogenous substances in and out of cells at various sites in the body.  Some drugs interact with transporters either as substrates or modulators (inhibitors or inducers), therefore, evaluation of transporter mediated drug-drug interactions (DDI) during drug development and post-approval is important to formulate clinical management strategies and ensure the safe and effective use of concomitantly administered drugs.  

     An integral part of a comprehensive clinical pharmacology program includes assessing the effect of an investigational drug on various transporters.  This assessment may be completed by either conducting several DDI trials (generally a trial for each transporter modulated by the investigational drug) or by conducting one trial to explore the effect of the investigational drug on the pharmacokinetics of several simultaneously administered (at therapeutic dose or microdose) probe drugs (“probe cocktail” approach). 

     More recently, the idea of assessing changes in the concentration of endogenous biomarkers (which are substrates of clinically relevant transporters) to gain insight on the potential of a drug to inhibit transporter activity has received widespread attention. Numerous publications and presentations by various investigators have highlighted how endogenous biomarkers can enable early “derisking” by assessing DDI potential over a wide range of inhibitor exposures, facilitate quantitative prediction of DDIs and provide mechanistic insights into observed DDIs. 

    Target Audience

    Physicians, Pharmacists, PhDs and other healthcare professionals interested in the evaluation of transporter-mediated DDIs during drug development and post-approval.

    Learning Objectives

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

    1. Learn how the transporter only probe cocktail trial approach has been used in drug development;
    2. Explain the advantages and challenges of using microdose trials for assessment of transporter-mediated DDIs;
    3. Describe the emerging role of endogenous biomarkers in the assessment of transporter-mediated DDIs;
    4. Discuss how the assessment of endogenous biomarkers can be integrated in probe cocktail trials for comprehensive characterization of transporter-mediated DDI assessments.
  • Contains 1 Component(s)

    This webinar is part of a 3 Webinar series "Exceeding Expectations to Land Your Dream Job" that will guide the audience on essential skills and technical aspects required during job application and interview processes to meet hiring manager expectations (industry, academic, regulatory, clinical). This webinar was recorded and is now available On Demand. It will be available for up to three years following the date of the Live webinar.

    2023 ACCP Student, Trainee & Early-stage Professional Webinar: "Delivering an Effective Interview Presentation" | ON DEMAND

    On Demand: October 25th, 2023 to October 25th, 2026

    Target Audience:

    This webinar will be important to physicians, pharmacists, PhDs and other (students, trainees & early-stage professionals) seeking guidance and valuable insights on how to present an impactful scientific presentation and be well prepared for a robust Q&A as part of an interview process.

    Learning Objective:

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

    1. Discuss approaches for creating clear and concise presentation targets for the hiring audience and target position;
    2. Learn and understand key strategies to engage and retain the target audience's interest;
    3. Develop skills to approach Q&A sessions with confidence.
  • Contains 1 Component(s)

    This webinar is part of a 3 Webinar series "Exceeding Expectations to Land Your Dream Job" that will guide the audience on essential skills and technical aspects required during job application and interview processes to meet hiring manager expectations (industry, academic, regulatory, clinical). This webinar was recorded and is now available On Demand. It will be available for up to three years following the date of the Live webinar.

    2023 ACCP Student, Trainee & Early-stage Professional Webinar: "Key Expertise/Insight to Ace the Interview" | ON DEMAND

    On Demand webinar: October 11th, 2023 to October 11th, 2026 

    Target Audience:

    This webinar will be important to physicians, pharmacists, PhDs and other (students, trainees & early-stage professionals) seeking guidance and valuable insights on how to prepare for  and ace an interview to get the job you want!

    Learning Objective:

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

    1. Navigate etiquette expectations throughout introductions and the interview process;
    2. Identify appropriate and inappropriate behaviors during the virtual and on-site job interview;
    3. Formulate directed and meaningful questions and answers during the interview process.

    Islam Younis, PhD, MSc

    Senior Director

    Merck & Co Inc

    Lorraine M. Rusch, PhD

    Chief Executive Officer

    Cardiovascular Clinical Sciences Foundation

  • Contains 1 Component(s)

    This webinar is part of a 3 Webinar series "Exceeding Expectations to Land Your Dream Job". In the first webinar, Crafting a High-impact CV, Attendees will be will provided with valuable tips and strategies for crafting a high-impact CV.

    2023 ACCP Student, Trainee & Early-stage Professional Webinar: "Crafting a High Impact CV" | ON DEMAND

    On Demand: September 20th, 2023 to September 20th, 2026

    Target Audience:

    This webinar will be important to physicians, pharmacists, PhDs and other (students, trainees & early-stage professionals) seeking guidance and valuable insights on developing a high-quality, impactful CV that will get the attention of  HR and the hiring managers.

    Learning Objective:

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

    1. Discuss the employer's perspectives on the screening and hiring process;
    2. Identify ways to develop and feature unique skills and experiences in a high impact CV based on targeted career goals;
    3. Utilize professional and social platforms effectively.
  • Contains 1 Component(s)

    This webinar will be important to Students, Trainees & Early-stage Professionals seeking guidance from career coaches and successful professionals on how to apply critical tools to nurture trust, purpose and gratitude to achieve career resilience that empowers professional success and personal fulfillment.

    2023 ACCP Student, Trainee & Early-stage Professional Webinar: Achieving Career Resilience to Cherish Professional Success & Personal Fulfillment: A Fireside Chat with Karthik Venkatakrishnan, PhD & Beth Kennedy, MS, LMFT | ON DEMAND

    On Demand: August 24th, 2023 to August 24th, 2026

    Target Audience:

    This webinar will be important to Students, Trainees & Early-stage Professionals seeking guidance from career coaches and successful professionals on how to apply critical tools to nurture trust, purpose and gratitude to achieve career resilience that empowers professional success and personal fulfillment.

    Learning Objective:

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

    1. Learn how to identify your Ikigai (your "Why") with Purpose Orientation;
    2. Understand how to discover and nurture your brand;
    3. Boost resilience by developing effective skills for time & energy management using the 4-Quadrant Theory.

  • Contains 3 Component(s), Includes Credits

    This webinar focuses on an overview of the importance to engage with the diverse community throughout clinical trials design and implementation. Attendees are provided with concrete examples of the different approaches of engaging with the community for under-represented populations. Current initiatives of regulatory agencies and drug companies to include special populations in clinical trials are presented and discussed. This session enables the audience to gain practical perspectives from multiple stakeholders including patient advocates, drug developers, health care practitioners and regulators.

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    2023 ACCP IDE Webinar: Engaging With the Community to Achieve Inclusivity, Equity & Diversity in Drug Development & Approval: Where to Start | ON DEMAND

    On Demand webinar recording: August 23rd, 2023 to August 23rd, 2026

    Why is this webinar important to your practice? 

    Racially and ethnically diverse study participants have been frequently under-represented in clinical trials. Public health and optimal health outcomes among racially, ethnically and gender diverse populations require a closer look at clinical trial disparities and how to improve design and conduct of studies. Other unrepresented populations include people with obesity, physical and mental health conditions limiting their access to clinical trials, including pregnant people.This lack of diversity among clinical trials participants can lead to an inability to fully characterize the impact of important differences in pharmacokinetics, safety and efficacy profiles. Clinical trials are critical part of the drug development process prior to market approval and require time and significant financial and organizational investment.  When diversity is not accounted for during the clinical trial and recruitment, access to a drug upon approval may not be inclusive for all and equitable to the populations in need.

    This webinar will focus on an overview of the importance to engage with the diverse community throughout clinical trials design and implementation. Attendees will be provided with concrete examples of the different approaches of engaging with the community for under-represented populations. Current initiatives of regulatory agencies and drug companies to include special populations in clinical trials will be presented and discussed. This session will enable the audience to gain practical perspectives from multiple stakeholders including patient advocates, drug developers, health care practitioners and regulators.

    Target Audience:

    Graduate students, post-doctoral fellows/trainees, early-stage and advanced professionals working in clinical trial design and implementation. 

    Learning Objectives

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

    1. Gain competence and improve performance to provide high quality care.

    2. Increase evidence-based new medical knowledge.

    3. Learn interdisciplinary educational strategies to improve patient safety and to facilitate patient-centered care.

  • Contains 5 Component(s), Includes Credits

    Venetoclax is an approved BCL-2 inhibitor that is primarily metabolized by cytochrome P450 3A (CYP3A). Although venetoclax exposure has been well characterized with 1 concomitant CYP3A inhibitor, complex drug-drug interactions involving more than 1 inhibitor have not been systematically evaluated despite the common polypharmacy in the target populations. In this webinar, the author will leveraged physiologically based pharmacokinetic (PBPK) and population PK modeling to describe the potential impact of multiple concomitant CYP3A inhibitors on venetoclax pharmacokinetics. The modeling approaches were informed by clinical data in the presence of single or multiple CYP3A inhibitors, and the effects of 1 or more inhibitors were systematically evaluated within these modeling frameworks. Learners that complete this activity will be able to describe the potential impact of multiple concomitant CYP3A inhibitors on venetoclax pharmacokinetics (PK) using physiologically based pharmacokinetic (PBPK) and population PK modeling.

    2023 ACCP Virtual Journal Club Webinar: Impact of Multiple Concomitant CYP3A Inhibitors on Venetoclax Pharmacokinetics: A PBPK and Population PK-Informed Analysis | ON DEMAND

    On Demand webinar recording: August 16th, 2023 to August 16th, 2026

    Why is this article important to your practice? 

    Venetoclax is an approved BCL-2 inhibitor that is primarily metabolized by cytochrome P450 3A (CYP3A). Although venetoclax exposure has been well characterized with one concomitant CYP3A inhibitor, complex drug-drug interactions involving more than one inhibitor have not been systematically evaluated despite the common polypharmacy in the target populations. In this webinar, the author will leverage physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PK) modeling to describe the potential impact of multiple concomitant CYP3A inhibitors on venetoclax pharmacokinetics. The modeling approaches were informed by clinical data in the presence of single or multiple CYP3A inhibitors and the effects of one or more inhibitors were systematically evaluated within these modeling frameworks. Learners that complete this activity will be able to describe the potential impact of multiple concomitant CYP3A inhibitors on venetoclax pharmacokinetics using PBPK and population PK modeling.

    Target Audience:

    Physicians, Pharmacists, PhDs and other healthcare professionals interested in PBPK/PopPK modeling, drug-drug interactions.

    Learning Objectives

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

    1. Describe the rationale to assess and quantify the potential impact of multiple concomitant CYP3A inhibitors on venetoclax pharmacokinetics;
    2. Describe the approaches and validation procedures used to inform dose adjustment for co-administration of venetoclax with multiple CYP3A inhibitors;
    3. Describe the benefits and limitations of these approaches to identify the potential impact of multiple concomitant medications in the development of new agents.

    Ahmed Salem, PhD

    Director

    AbbVie, Inc

    Dr. Ahmed Salem is a Senior Research Fellow of Clinical Pharmacology at Abbvie and an adjunct Professor at University of Minnesota. Dr. Salem got his PhD in Clinical Pharmacology in 2010 from the University of Minnesota with a focus on Pharmacometrics and a minor in Biostatistics. His research at UMN focused on Pharmacometric Applications in Infectious Diseases. At Abbvie, Dr Salem has led the clinical pharmacology, pharmacometrics and biopharmaceutics strategy of several small and large molecules in oncology, virology, and women’s health. He contributed to 14 different FDA and EMA approvals of new drugs, dosage forms or dosage regimens. He has worked on over 180 Phase I, II and III clinical trials. He has over 200 publications with an i-10 index of 114 and H index of 40 and holds seven patents in the USA and EU. 

    Recently, the American College of Clinical Pharmacology (ACCP) selected Dr Salem as the 2022 recipient of the prestigious Tanabe Investigator Award. He was also the 2018 recipient of the High Impact Article Award by the American Association of Pharmaceutical Scientists (AAPS) in addition to other awards and recognition from the IQ-Clinical Pharmacology Leadership Group (CPLG), UMN and
    AbbVie Inc. Dr. Salem has also been an invited speaker and chair at multiple conferences such as the American Society for Clinical Pharmacology & Therapeutics (ASCPT), ACCP and Accelerating Anti-Cancer Agent Development & Validation (AAADV). He also recently established a joint industry-academia postdoctoral fellowship in clinical pharmacology and pharmacometrics between Abbvie and University of Minnesota.

    Ahmed Hamed Salem, PhD, Director, AbbVie Inc is an employee at AbbVie Inc. All of the relevant financial relationships for this individual have been mitigated.