A Closer Look at FDA’s Interchangeable Biosimilar Approvals
Home Study Webinar
Free Activity – available through February 28, 2023.
In advance of Food and Drug Administration’s approval of interchangeable biosimilars in 2023, presenters will cover a range of topics, including:
- regulatory and approval process for biosimilars,
- interchangeable biosimilar designations and regulations,
- pharmacists’ responsibility to patients receiving interchangeable biosimilars, and
- how biosimilar trends may affect the health care environment.
Panelists will also discuss their experience with biosimilars in the field and common questions surrounding interchangeable biosimilars.
This home study webinar is a recording of the live activity that was held on February 11, 2022.
How to Access the Webinar and Earn CPE
The complimentary webinar is eligible for Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. More details regarding the presentations, CPE activity credits, and browser requirements can be found in the CPE Activity Information guide.
Follow the steps below to access the home study webinar and claim CPE credit:
- Complete the interest form for the desired home study.
- Check your email to get the access code for the requested home study.
- Log in to NABP’s CPE Submission Site and select the “Home Study CPE” tab.
- If you do not have a log in for Learner Community, you will need to create an account.
- Enter the access code provided in your email and click “Redeem Code.”
- Enter only one code at a time.
- View the recording, complete the activity in its entirety, including watching the full video, and pass the post-test. Once completed, the Credit section will unlock.
- Select the appropriate credit (pharmacy or pharmacy technician), enter your NABP e-Profile ID and date of birth, and click the “claim” button to earn credit.
Claims must be submitted within 60 days from the date you opened the activity.
Dr Ilisa Bernstein is currently the Interim CEO at the American Pharmacists Association (APhA). She is responsible for leading the development and implementation of APhA’s strategies related to pharmacy practice and professional affairs, advocacy, and government affairs.
She has over 30 years of experience advocating for pharmacy and patients at FDA, where she has held several senior leadership positions. Prior to joining APhA, Dr Bernstein was deputy director of FDA’s Office of Compliance in the Center for Drug Evaluation and Research, leading policies, compliance, and enforcement in areas including drug compounding, supply chain security, drug manufacturing and quality, drug shortages, and post-market drug safety. Dr Bernstein also served as director of pharmacy affairs for FDA and senior advisor for regulatory policy in the Office of the Commissioner. She started at FDA as a clinical pharmacology reviewer of investigational and new drug applications.
Previously, Dr Bernstein was senior associate director of worldwide regulatory affairs for Pfizer and completed a post-doctoral clinical residency at the National Institutes of Health. She earned her Doctor of Pharmacy from the University of Michigan and her Juris Doctor from American University Washington College of Law.
Dr John Clay Kirtley is the Executive Director of the Arkansas State Board of Pharmacy. He currently serves as a member and president of the ACPE’s Board of Directors as well as the president of MALTAGON, a professional association of boards of pharmacy across the Southeast US. Dr Kirtley completed his pre-pharmacy coursework at Ouachita Baptist University in Arkadelphia, AR and graduated from the University of Arkansas for Medical Sciences College of Pharmacy with his Doctor of Pharmacy degree. Dr Kirtley and his wife Melanie, who is also a pharmacist, live outside Little Rock with their two children, Allison and Jack.
Dr Robert Popovian is the Founder of the strategic consulting firm Conquest Advisors. He also serves as chief science policy officer at the Global Healthy Living Foundation, vice president of health economics and policy for Equideum Health and senior healthy policy fellow at the Progressive Policy Institute. He previously served as Vice President, US Government Relations at Pfizer. He also serves an as advisor to the Board of Councilors for the University of Southern California School of Pharmacy.
One of the country’s foremost experts on every significant facet of biopharmaceuticals and the health care industry, he is a recognized authority on health economics, policy, government relations, medical affairs, and strategic planning. Dr Popovian has published extensively and referenced on the impact of biopharmaceuticals and health policies on costs and clinical outcomes in the most prominent medical sources and media publications, including the Clinical Economics and Outcomes Research, The Oncologist, Journal of Vaccines and Vaccinations, Health Science Journal, USA Today, Washington Examiner, Managed Healthcare Executive, and Morning Consult. He is also a sought-after speaker and has been invited to provide detailed presentations, briefings, and expert reviews for the US Congress, dozens of state legislatures, and at conferences and medical symposiums throughout the country and around the world. He was an invited guest speaker for the Center for Biosimilars.
Dr Popovian is one of the few researchers to study and publish both clinical and policy-related economic analysis as well as empirical data regarding emerging payment models in the US health care system and for biopharmaceutical reimbursement. His insight and analysis also led to one of the first inclusions of health outcomes data regarding a biopharmaceutical labeled indication.
Dr Popovian completed his Doctor of Pharmacy and Master of Science in Pharmaceutical Economics and Policy degrees at the University of Southern California (USC) with honors. He has also completed a residency in Pharmacy Practice/Adult Internal Medicine and Infectious Diseases at the Los Angeles County-USC Hospital and a fellowship in Pharmaceutical Economics and Policy at USC.
Home Study Registration
Complete the form to receive an enrollment code for the Home Study Program(s). You will need to log in to NABP’s CPE Submission Site and enter the enrollment code to view the webinar and earn credit.