This program will provide a broad overview of the main laws and regulations governing clinical trials, as well as the typical terms included in clinical trial agreements, and issues commonly encountered during their negotiation. The speakers will also briefly discuss other agreements commonly required between research sponsors, hospitals, physicians, physician groups, and other entities involved in research activities or oversight. Our speakers have experience representing sponsors, healthcare institutions, and individual researchers, so we expect a lively discussion.
Amanda Coulter, of counsel at Coppersmith Brockelman, advises clients in the healthcare industry on clinical research matters. She has extensive experience developing research compliance policies and processes, template forms, and template agreements. She assists clients by reviewing and negotiating confidentiality agreements, data use agreements, business associate agreements, federal grants and subcontracts, and industry-sponsored clinical trial agreements. Before joining Coppersmith Brockelman, she was Associate Director of the Sponsored Projects office at the University of Michigan, where she trained and managed a team of contract negotiators and research administrators dedicated to clinical research contracts and grants. She also developed, coordinated and administered training on research contracts, financial award management, grant administration, and compliance to physicians, clinical research coordinators, and research administrators.
Miranda Preston is a transactional attorney and shareholder at Milligan Lawless, P.C. She primarily represents clients in the health care and life sciences industries, with a focus on clinical studies and preclinical research. She serves as chief outside counsel for a clinical research organization sponsoring multiple Phase 0 and Phase 3 studies, including an international Phase 3 study. Her work in the clinical research space includes the review and drafting of material transfer agreements, confidentiality agreements, collaborative research agreements, master research services agreements, grant agreements, industry-sponsored clinical trial agreements, investigator-initiated trial agreements, agreements delegating regulatory responsibilities, and subcontracts. Miranda’s practice outside of the research context includes representation of corporate and health care clients on a variety of matters, including general corporate matters and compliance with health care laws and regulations.
To Register
Regardless of membership, you must login to purchase tickets. To do so:
- Under ticket information, click “login to purchase”
- This will take you to the login page. If you are a member, use the login information utilized for your membership. If you are a non-member, you will need to create an account to purchase a ticket. Non-members who have not created an account yet, must select “Register” along the bottom next to “Lost your password?”
- From there, you will create an Account by entering a username, name, email address, and password. Then select “Complete Sign Up.”
- The account will need to be activated by using the link in a confirmation email sent to the registered email address. Once the account is activated, you will login using the credentials provided (username and password).
- Once logged in, navigate to the Program page and select the number of tickets needed and select “Get Tickets” to proceed with the checkout process.
Should you have any questions or issues with the registration process, please contact us at azhealthcareattorneys@gmail.com.
Once you have registered online, you will receive a calendar invitation and information about accessing the program. This program will be held via video conference through Zoom. The program cost is as follows:
- Member – $20
- Non-Member – $40
- Student Member – $5
- Student Non-Member – $25
Interested in becoming an AzSHA Member? Sign-Up Here.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.