2nd Clinical Trial Agreements Forum

Foley Partner Kyle Faget and Senior Counsel Jennifer Hennessy, members of the firm’s Health Care Industry Team, will be presenting at the 2^nd Clinical Trial Agreements Forum on September 16, 2021.

Jennifer’s presentation will take place at 10:00 a.m. ET on September 16, and her presentation is entitled “Impact of the EU General Data Protection Regulation (GDPR) and Recently Adopted Standard Contractual Clauses (SCCs) on Clinical Trial Agreements. GDPR has been in effect for a few years, but the European Commission adopted new versions of the SCCs on June 4, 2021. What are the most important takeaways for CTAs? How quickly must you implement the new versions of the SCCs? Her session will:

• Summarize the purpose and key impacts of GDPR and the SCCs on CTAs
• Analyze the impact on patient rights and consent management in particular
• Clarify responsibilities of involved parties

Kyle’s presentation will take place at 1:00 p.m. ET on September 16^th, and her presentation is entitled “Decipher How Best to Incorporate the Use of Telemedicine in Virtual Clinical Trails into the CTA.” CTAs are incorporating virtual clinical trials and a reliance on telemedicine. While standards may be released at some point in the future, currently telemedicine can be difficult to navigate. Her presentation will:

• Evaluate state by state considerations and standards regarding telemedicine
• Outline the risks involved in telemedicine and know what to account for
• Uncover the requirements for informed consent via telemedicine