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Contains 5 Component(s), Includes Credits Includes a Live Web Event on 10/09/2025 at 2:45 PM (EDT)
This webinar will increase learner knowledge of the effects of diet-and-exercise-induced weight loss on drug-metabolizing enzymes and gastric emptying in patients with obesity. The program will cover drug metabolizing enzymes are affected by diet-and-exercise-induced weight loss in patients with obesity. Learners that complete this webinar will recognize patients with obesity can have lower CYP1A2, CYP2C19, and CYP3A4 activity that counterintuitively implies the need for lower doses of drugs metabolized by these pathways.
2025 ACCP Virtual Journal Club Webinar: Examining the Impact of Diet-and-Exercise-Induced Weight Loss on Drug Metabolism and Gastric Emptying in Patients with Obesity - LIVE
Live Session: Thursday, October 9th, 2025, from 12:00 to 1:00 PM ET
On Demand: October 9th, 2025 to October 9th, 2028
Why is this webinar important to your practice?
This webinar will increase learner knowledge of the effects of diet-and-exercise-induced weight loss on drug-metabolizing enzymes and gastric emptying in patients with obesity. The program will cover drug metabolizing enzymes are affected by diet-and-exercise-induced weight loss in patients with obesity. Learners that complete this webinar will recognize patients with obesity can have lower CYP1A2, CYP2C19, and CYP3A4 activity that counterintuitively implies the need for lower doses of drugs metabolized by these pathways.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other healthcare professionals interested in the impact of diet & exercise-induced weight loss on patients with obesity.
Learning Objectives
After completing this activity, the learner will be able to:
- List at least one cytochrome (CYP) enzyme whereby activity increased after weight loss;
- Define the parameter used to assess gastric emptying time;
- Identify at least one single time point metabolic ratio that correlated with exposure (AUC) ratio.
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Contains 45 Component(s), Includes Credits
Thank you for registering for the ACCP Annual Meeting. Please complete a self-assessment of your knowledge.
The ACCP Annual Meeting Self-assessment is available only to registered attendees.
Please complete the self-assessment of your knowledge for the sessions you attend.
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Contains 3 Component(s), Includes Credits
Thank you for registering for the 2025 ACCP Annual Meeting PMWS: Artificial Intelligence & Machine Learning: Revolutionizing Clinical Pharmacology. Please complete a self-assessment of your knowledge.
The ACCP Annual Meeting PMWS Self-assessment is available only to registered attendees of the Pre-Meeting Workshop.
Please complete the self-assessment of your knowledge.
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Contains 36 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 12/31/2028
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Contains 4 Component(s), Includes Credits
This webinar will explore how pharmacokinetic (PK) bridging is a cornerstone of successful formulation changes, with a specific focus on intravenous (IV) to subcutaneous (SC) transitions. Industry and regulatory experts will examine how the PK landscape has evolved and share practical, forward-looking strategies—including model-informed drug development approaches—to address the complexities of bridging. Real-world case studies will provide insight into what has worked, what hasn’t and why. Whether you're in early development or managing a late-stage formulation shift, this session will equip you with the scientific, regulatory and strategic knowledge needed to implement effective PK bridging and streamline development. Attendees will gain a clear understanding of when PK bridging is essential, how to recognize key decision points and what tools and cross-functional perspectives are shaping the future of route transition in drug development. Learners who complete this activity will have enhanced knowledge in the use of PK bridging strategies in therapeutic drug monitoring.
2025 ACCP STEP & ESP Webinar: Navigating PK Bridging: Essential Strategies for Streamlining Change in Route of Administration in Drug Development
Live Session: Wednesday, June 25th, 2025, from 1:00 to 2:30 PM ET
On Demand: June 25th, 2025 to June 25th, 2028
Target audience:
Interprofessional team of MDs, PharmDs, PhDs and other healthcare professionals across the spectrum of academia, industry, regulatory and clinical settings who are interested in the use of PK bridging strategies in therapeutic drug monitoring.
Objectives
After completing this activity, the learner will be able to:
- Recognize the importance and need for PK bridging during therapeutic development;
- Identify key scenarios requiring PK bridging strategies between IV and SC formulations drug drug development;
- Discuss the challenges and opportunities for model-informed PK bridging strategies;
- Describe the multidisciplinary perspectives on PK bridging in practice.
Description:
This webinar will explore how pharmacokinetic (PK) bridging is a cornerstone of successful formulation changes, with a specific focus on intravenous (IV) to subcutaneous (SC) transitions. Industry and regulatory experts will examine how the PK landscape has evolved and share practical, forward-looking strategies—including model-informed drug development approaches—to address the complexities of bridging. Real-world case studies will provide insight into what has worked, what hasn’t and why. Whether you're in early development or managing a late-stage formulation shift, this session will equip you with the scientific, regulatory and strategic knowledge needed to implement effective PK bridging and streamline development. Attendees will gain a clear understanding of when PK bridging is essential, how to recognize key decision points and what tools and cross-functional perspectives are shaping the future of route transition in drug development. Learners who complete this activity will have enhanced knowledge in the use of PK bridging strategies in therapeutic drug monitoring.
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Contains 5 Component(s), Includes Credits
This webinar will explore how model-informed drug development (MIDD) techniques are being used to support regulatory approval of new products through the 505(b)(2) pathway. Through detailed case studies, learners will gain practical insight into how the US Food & Drug Administration has accepted model-based justifications for dosing, safety and efficacy, using examples involving fixed-dose combinations, high-potency opioid antagonists and dose optimization in renal or hepatic impairment. Learners that complete this event will understand the significance of model-informed approaches in drug development and regulatory decisions associated with 505(b)(2) submissions.
2025 ACCP Virtual Journal Club Webinar: Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions - ON DEMAND
Live Session: Tuesday, June 10th, 2025, from 12:00 to 1:00 PM ET
On Demand: June 10th, 2025 to June 10th, 2028
Why is this webinar important to your practice?
This webinar will explore how model-informed drug development (MIDD) techniques are being used to support regulatory approval of new products through the 505(b)(2) pathway. Through detailed case studies, learners will gain practical insight into how the US Food & Drug Administration has accepted model-based justifications for dosing, safety and efficacy, using examples involving fixed-dose combinations, high-potency opioid antagonists and dose optimization in renal or hepatic impairment. Learners that complete this event will understand the significance of model-informed approaches in drug development and regulatory decisions associated with 505(b)(2) submissions.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other healthcare professionals interested in the application of MIDD in regulatory applications.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe applications of model-informed approaches that have been utilized to provide evidence of effectiveness;
- Explain how model-informed approaches have been applied to optimize dosing in patient subgroups;
- Explain how a model-informed approach has been used to inform policy.
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Contains 4 Component(s), Includes Credits
Cytokine release syndrome (CRS) is a life-threatening systemic inflammatory syndrome involving elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions and monogenic disorders. Many therapeutics such as cancer immunotherapy (CAR-T, CD3 bispecifics, etc.) can lead to CRS. To mitigate the CRS risk, various approaches were investigated in clinical trials, including priming dosing (step-up dosing, split dosing, dose fractionation, etc.) and premedications. Translational modeling approaches such as mechanistic quantitative systems pharmacology models were also developed to optimize the dose in the clinic to minimize the CRS. In addition, CRS could also result in drug-drug interaction (DDI) risks due to the suppression of CYP enzymes and transporters by the proinflammatory cytokines. Physiologically-based pharmacokinetic approaches have been utilized to assess CRS mediated DDI risks. This activity will focus on the current scientific aspects for CRS and its implications in drug development as well as future perspectives. Learners who complete this activity will have enhanced knowledge utilizing case examples and discussions.
ACCP Clinical Practice Webinars: Cytokine Release Syndrome: Implications in Drug Development - On Demand
Live Session: Thursday, May 29th, 2025, from 12:00 to 1:00 PM ET
On Demand: May 29th, 2025 to May 29th, 2025
Why is this webinar important to your practice?
Cytokine release syndrome (CRS) is a life-threatening systemic inflammatory syndrome involving elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions and monogenic disorders. Many therapeutics such as cancer immunotherapy (CAR-T, CD3 bispecifics, etc.) can lead to CRS. To mitigate the CRS risk, various approaches were investigated in clinical trials, including priming dosing (step-up dosing, split dosing, dose fractionation, etc.) and premedications. Translational modeling approaches such as mechanistic quantitative systems pharmacology models were also developed to optimize the dose in the clinic to minimize the CRS. In addition, CRS could also result in drug-drug interaction (DDI) risks due to the suppression of CYP enzymes and transporters by the proinflammatory cytokines. Physiologically-based pharmacokinetic approaches have been utilized to assess CRS mediated DDI risks. This activity will focus on the current scientific aspects for CRS and its implications in drug development as well as future perspectives. Learners who complete this activity will have enhanced knowledge utilizing case examples and discussions.
Target Audience:
Interprofessional team of graduate students, postdoctoral fellows/trainees and professionals in the field of pharmacy, pharmacometrics, clinical pharmacology and clinical pharmacy practice. This activity is applicable to participants across academia, pharmaceutical industry and regulatory agencies interested in expanding their knowledge in cytokine release syndrome.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the cytokine release syndrome (CRS);
- Discuss the implication of CRS in drug development;
- Explain the utility of modeling approaches for prediction of CRS;
- Describe the utility of modeling approaches for estimating CRS mediated DDI.
Benjamin Colton (Moderator)
Section Chief, Clinical Pharmacy Specialists
National Institutes of Health
Dr. Colton received his Doctor of Pharmacy from Drake University before completing a postdoctoral fellowship in Infectious Diseases Pharmacotherapy at the University of Illinois at Chicago. In 2015, Dr. Colton joined the NIH Clinical Center's Pharmacy Department. As the Infectious Diseases and Immunology Clinical Pharmacy Specialist, Dr. Colton collaborates with NIAID Intramural Research Program Clinical Investigators on the design, implementation, conduct, and interpretation of early phase clinical trials. His contributions to this translational research include proctocol study design, dose selection, dose modification, risk management strategies, and pharmacometric approaches and analysis. Current collaborations include research evaluating immunomodulating therapies for patients with primary immunodeficiencies and autoinflammatory disorders and optimizing antimicrobial therapy for fungal and mycobacterial disease. Further, Dr. Colton maintains a clinical practice at the NIH Clinical Center, leveraging his expertise to support the pharmacotherapy needs of these unique patient populations. Collectively, these collaborations and patient care advance the knowledge and understanding of the complexity of the immune system, the interface between host immunity and pathogen, and pioneering interventions to modulate these complex interactions to improve the health of patients with primary immunodeficiencies, autoinflammatory conditions, disseminated fungal and mycobacterial infections, and their accompanying complications.
Yanke Yu
Distinguished Scientist
Genentech Inc/Roche
Dr. Yanke Yu, is a distinguished scientist of clinical pharmacology in Genentech Inc. Prior to Genentech, Dr. Yu held positions in Pfizer Inc. and Eisai Inc. Dr. Yu has a wealth of experience in clinical pharmacology, and modeling and simulation. Following a 13+ year industry career, Dr. Yu contributed to multiple products regulatory approvals in both oncology and immunology. Prior to his industry career, Dr. Yu completed his Ph.D. in Pharmaceutical Sciences at the University of Michigan. Dr. Yu is a prolific publisher, with 39 peer-reviewed articles and 50+ abstracts/posters/oral presentations.
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Contains 5 Component(s), Includes Credits
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
2025 ACCP Virtual Journal Club Webinar: Safety, Tolerability & Pharmacokinetics of Oral Doses of the Sirtuin 6 Activator SP-624 - ON DEMAND
Live Session: Tuesday, March 18th, 2025, from 12:00 to 1:00 PM ET
On Demand: March 18th, 2025 to March 18th, 2028
Why is this webinar important to your practice?
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other health care professionals, including Clinical Pharmacologists and Allied Health Services, who are involved or interested in the dosing of Sirtuin 6 Activator SP-624.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the pharmacokinetics of SP-62;
- Identify key characteristics of dose estimation via ascending dose response of Sirtuin 6 Activator;
- Describe the safety assessments based on the adverse events, serious adverse events and treatment emergent adverse events (TEAEs) of Sirtuin 6 Activator;
- Discuss the use of pharmacokinetics in early drug development.
Vatsalya Vatsalya (Moderator)
Assistant Professor of Medicine
Univ of Louisville
Dr. Vatsalya is an Assistant Professor of Medicine in the Department of Medicine at the University of Louisville in the Division of Gastroenterology, Hepatology and Nutrition. He is also affiliated with the VA Robley Rex Medical Ctr as a clinical scientist. Dr. Vatsalya is trained as a physician, but his primary role is research and support for patients with their mental health conditions. He is an addiction specialist, licensed in addiction and mental health in Kentucky. He is a PI on medication trials on AUD, funded both institutionally and federally, including the National Inst of Health. During his fellowship, he developed and validated the food-alcohol task, which is used widely in human neural-mechanistic-treatment studies (disease, and non-treatment-seeking cohorts). He has developed novel clinical paradigms to study treatment efficacy in various patient populations. Dr. Vatsalya has a novel drug registered with the US Patent and Trademark Office for the treatment of AUD-ALD as a dual-target therapy, licensing efforts and phase I preparation have been initiated. Notably, he was also in a group of addiction investigators that developed the WHO's ICD 11 code for alcohol hangover conditions. He has an independent clinical research lab and has several clinical publications in high-impact, prestigious-ranking national and international journals. He mentors several clinical trainees and clinical and non-clinical students.
Greg Rigdon
Senior Vice President, Scientific Affairs
Arrivo Bioventures LLC
Dr. Greg Rigdon is Senior Vice President of Scientific Affairs at Arrivo Bioventures LLC. Dr. Rigdon’s drug development experience includes discovery through Phase 4 clinical trials and his regulatory experience includes IND and NDA filings. He has over 30 years experience in the industry from running a neuropharmacology laboratory at Burroughs Wellcome to managing clinical development teams at Glaxo Wellcome and Icagen to serving as a clinical pharmacology consultant. He has experience in multiple therapeutic areas: psychiatry, neurology, sickle cell disease, preeclampsia and multiple GI indications. In his current role he manages the nonclinical aspects of drug development, interacts with regulatory authorities and designs clinical trials.
Dr. Rigdon has authored/co-authored over 30 journal articles in pharmacology, neuroscience and clinical research. He is also an inventor with multiple patents and has guest lectured at the University of North Carolina at Chapel Hill, North Carolina State University and Campbell University. Greg earned his PhD in Pharmacology from Texas Tech University Health Sciences Center in 1985.William Wargin
Pharmacokineticist
Sirtsei Pharmaceuticals Inc
Dr. Wargin has over 20 years of experience as a pharmacokineticist, having worked with 60+ small and large pharmaceutical companies developing drugs in several therapeutic areas including CNS, oncology, anti-viral, cardiovascular and metabolic disease. In this context, he has worked in nonclinical drug development including in vitro and in vivo metabolism and pharmacokinetics. During Phase 1 development, he participated in design and implementation of clinical pharmacology studies from First-in-Human to bioequivalence studies for new formulations post-approval, partnered with CROs for protocol development, review and study conduct, and provided pharmacokinetic and PK/PD data analysis of data and report writing. Dr. Wargin has written several nonclinical ADME/PK sections of IND submissions and clinical pharmacology sections of NDAs in CTD format and has participated in 10+ pre-IND meetings in various therapeutic areas.
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Contains 1 Component(s)
Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset - ON DEMAND WEBINAR
2025 ACCP STEP & ESP Webinar: Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset
Live webinar: February 26, 2025 from 1:00 - 2:30 PM ET
On-demand webinar recording: February 26, 2025 to February 26, 2028
Target audience:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers that may require an assessment of their skillset.
Objectives
After completing this activity, the learner will be able to:
1. Identify specific skill sets essential to your career path;
2. Navigate resources to supplement current experiences;
3. Strategize on building a professional and mentoring network;
4. Adopt a lifelong learning mindset to stay current in the field.
Description:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers will benefit from this webinar that elucidates the skills required across the spectrum of academic, industry, clinical, regulatory or consulting careers. Hear from established experts in the field as they share their experiences and knowledge as leaders in the field and hiring managers about what skills are desirable to achieve not only your next position but long-term success. Panel discussions will be followed by a Question & Answer period.
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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 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
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