Vaccines Law and Policy

Vaccines Law and Policy

Saturdays, June 6 - June 27 (11:00 am - 4:15 pm ET)

This course is Fully Remote/Virtual

The Schedule is as follows:

●      Saturday, June 6 (11 am to 4:15 pm ET) Virtual Synchronous Session

●      Saturday, June 20 (11 am to 4:15 pm ET) Virtual Synchronous Session

●      2 hours of additional asynchronous material

●      Saturday, June 27 (11 am to 12:00 pm ET) Virtual Synchronous Review Session

Course Description

This course will introduce students to the broad range of legal and policy issues that impact the biopharmaceutical industry in the United States. Through reading materials, lectures and discussions, students will explore the regulatory framework governing biopharmaceutical innovation and patient access to new therapies. This course will delve into the laws and regulations related to vaccines and vaccination and discuss policy implications.

Meet your instructor:

Sonali Gunawardhana is Assistant General Counsel at Becton Dickinson, a large medical device company. She is also an adjunct professor at AUWCL and The Catholic University of America. Previously, she served as Assistant General Counsel-Regulatory Law at Cardinal Health and previously as Chief Counsel FDA and Regulatory Law at McKesson. She has also served as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP. Prior to her tenure in private practice, she served as Regulatory Counsel at the FDA for nearly ten years. There she assisted on a variety of legal and policy issues in the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition. Sonali also serves on the Board of Directors for the Food & Drug Law Institute.

Policies and Processes Refunds:

The following is the refund policy for this Health Law and Policy Program Summer course administered by the Washington College of Law and registered through our Professional and Lifelong Learning Portal (https://american.catalog.instructure.com/ ).

Participants enrolled in the course will be eligible for a refund if the course is dropped and a refund is requested by Noon ET on Friday, May 22nd. If a refund is requested, the net refunded amount will be the tuition minus 4%. Withdrawal from the course after this deadline will not qualify for a refund; however, electronic course materials will be provided.

Notifications of course withdrawal and refund requests should be directed to Professor Asha Scielzo via email at: scielzo@american.edu.

Refund requests not meeting the deadline (noon ET on Friday, May 22nd) will not be accepted.

Payments and fees:

For payments with credit cards, debit cards or bank accounts, the tuition cost includes a non-refundable 4% administrative fee. In case an eligible refund is requested, the net funds returned will be the tuition minus 4%.

Notice about AU Non-Credit Courses:

Non-credit courses are not recorded in American University transcripts. No credit is earned from these courses and grades are not posted. Learners enrolled in Non-Credit courses will not receive an AU ID or have access to services and or facilities reserved for AU students. Access to the AU library system will be available to all members of the greater Washington DC area through visitor services. See the link for more information https://www.american.edu/library/services/visitors.cfm

Questions about this course? Please contact:

ASHA B. SCIELZO, JD

Scielzo@american.edu

AUWCL HEALTH LAW AND POLICY PROGRAM

health@wcl.american.edu