www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Drug Topics: 3D Printing in Drug Development and Emerging Health Care
May 21, 2019
FDA
Activity Coordinator
Lesley Navin
Lesley.Navin@fda.hhs.gov
 
Series Description

This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, students, and other healthcare professionals, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety.


Lecture Description
This webinar will discuss the emerging paradigm shift in drug manufacturing by three-dimensional (or 3D) printing. It will focus on CDER's the use of emerging technology with respect to clinical medicine, and the pharmaceutical and regulatory sciences, as it relates to drug development and review.
References
  • Akm Khairuzzaman, Abdul Basit, Simon Gaisford, 3D Printing of Pharmaceuticals. Springer 2018.
  • Spritam (Levetiracetam) FDA-approved drug product labeling at www.fda.gov/DrugsatFDA
  • A. Khairuzzaman et., al., A new chapter in pharmaceutical manufacturing: 3D printed drug products, Adv. Drug Delivery Review., 108 (2017) 39-50.
  • Ashley Johnson, et al., 3D Printing in Product Development, AAPS Magazine, March 2017.
  • M.D. Prima, A. Khairuzzaman., et al., Additively manufactured medical products – the FDA perspective., 3D Printing in Medicine., 2016.
  • Clive Roberts et al., 3D printing of tablets containing multiple drugs with defined release profiles, Intl Journal of Pharmaceutics., Vol 494, Oct’ 2015.
Series Objectives
  • Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives After completion of this activity, the participant will be able to:
  • Identify the fundamental principles of 3D printing as it relates to design and manufacture of pharmaceutical drug products.
  • Describe the motivation driving the paradigm shift of on-demand manufacturing of personalized medicine in upcoming emerging digital health care structure.
  • Explain how various types of 3D printing platforms operate, their capability with respect to complex and precision drug design, manufacturing design and flexibility, and compare with current practice.
  • Summarize upcoming regulatory challenges of this 21st century digitalized manufacturing and its impact on health care structure.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, and students other healthcare professionals.
Agenda

Lecture 1 May 21, 2019
Time Topic Speaker
1:00 - 2:00 PM 3D Printing in Drug Development and Emerging Health Care Akm Khairuzzaman, B.Pharm., M.S., Ph.D
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research 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.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-020-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-020-L04-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
AAPA Credit
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Pharmacists will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Khairuzzaman, Akm, B.Pharm., M.S., Ph.D, Senior Chemistry Reviewer, FDA - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose
  • DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
  • Weinstein, Edward, M.D., Ph.D., Medical Officer, CDER FDA My spouse received Salary from EndoCentre of Baltimore for a role as Employee.

CE Consultation and Accreditation Team
  • Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
  • This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
  • This system is provided for Government-authorized use only.
  • Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
  • Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
  • By using this system, you understand and consent to the following:
    • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
    • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.