Jointly provided by Impact Education, LLC and Postgraduate Institute for Medicine.     This activity is supported by educational funding provided by Amgen. Tuesday, October 23, 2018 6:30 PM - 8:30 PM Orlando World Marriott Center Room: Canary 1-2 Orlando, FL Please note: No additional fee is required to attend this CME/CPE activity; however, registration to AMCP Nexus 2018 is required. Held in conjunction with Click here to download the slides from this symposium.   Hot Topics Operational challenges associated with biosimilars Interchangeability of biosimilars and reference biologics Regulatory processes leading to approval of biosimilars Differences between biosimilars and reference biologics and conventional generic drugs   Expert Faculty Presenters Vanita Pindolia, PharmD, BCPS, MBA Vice President, Ambulatory Clinical Pharmacy Programs_PCM Henry Ford Health System/Health Alliance Plan of Michigan James G. Stevenson, PharmD, FASHP Professor Department of Clinical Pharmacy University of Michigan College of Pharmacy Edmund Pezalla, MD, MPH CEO Enlightenment Bioconsult, LLC   Who Should Attend? This activity is designed to meet the educational needs of managed care pharmacy directors, clinical pharmacists, quality directors, medical directors, members of the AMCP, and other managed health care professionals attending AMCP Nexus 2018.   Statement of Need/Program Overview Biologic drugs have revolutionized the treatment of many acute and chronic conditions by providing more effective symptom control, improved patient quality of life, and enhanced other relevant clinical and humanistic outcomes. By 2020, it is anticipated that several "innovator" or "reference" biologics will lose patent protection. Consequently, interest in biosimilar or biologic products highly similar to an FDA-approved biologic product (with no clinically meaningful differences in terms of safety and effectiveness from the reference product) is intensifying.   Educational Objectives At the conclusion of this activity, participants should be able to demonstrate improved ability to: Describe the regulatory pathway including clinical trials, approval, and labeling Explain the differences between biosimilars and 1) reference biologics and 2) conventional generic drugs Discuss the interchangeability of biosimilars and reference biologics Outline the operational challenges associated with biosimilars   Agenda Date and Time Tuesday, October 23, 2018 6:30 PM - 8:30 PM Orlando World Center Marriott Room: Canary 1-2 Orlando, FL 6:30 PM Registration and Dinner Pre-Activity Learning Assessment and Opening Comments/Overview 6:35 PM Differentiating Biosimilars and Reference Products: Developmental and Regulatory Pathways James G. Stevenson, PharmD, FASHP 7:20 PM Addressing Challenges for Managed Care Posed by Biosimilars Edmund Pezalla, MD, MPH 7:45 PM Therapeutic Scenarios: Immunology Biosimilars Oncology Biosimilars Vanita Pindolia, PharmD, BCPS, MBA 8:15 PM Moderated Faculty Panel Discussion and Audience Q&A 8:30 PM Key Takeaways and Closing Comments; Post-Activity Assessment and Evaluation   Accreditation Information Joint Accreditation Statement In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Impact Education, LLC. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Continuing Medical Education The Postgraduate Institute for Medicine designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Continuing Pharmacy Education Postgraduate Institute for Medicine designates this continuing education activity for 2.0 contact hours (0.20 CEUs) of the Accreditation Council for Pharmacy Education. Universal Activity Number: JA4008162-9999-18-347-L04-P Type of Activity: Knowledge Interprofessional Continuing Education This activity was planned by and for the healthcare team, and learners will receive 2.0 Interprofessional Continuing Education (IPCE) credit for learning and change. Disclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. Americans with Disabilities Act ♿ Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc). Please contact Impact Education, LLC, prior to the live event at (215) 619-8812. Fee Information No additional fee is required to attend this CPE/CME activity. Please note: No additional fee is required to attend this CME/CPE activity; however, registration to AMCP Nexus 2018 is required. Pre-registration will close at 12:00 pm on October 22, 2018. Walk-in registration will be available at the time of the program. If you have any questions, please call (215) 619-8812 or email info@impactedu.net.