Contracting & Compliance Considerations in Clinical Trials

$195.00

CLE Credits earned: 2 GENERAL (or 2 LAW & LEGAL for WA state)

Participants will walk away from this session with an understanding of how to approach negotiating key provisions in a Clinical Trial Agreement, e.g., indemnification and subject injury, and how to approach negotiating key provisions in a Master Services Agreement with Contract Research Organizations. Participants will also learn about key compliance issues that must be considered when engaging in clinical trials, e.g., investigator selection, conflicts of interest and fair market value considerations.

This course is co-sponsored with myLawCLE.

Key topics to be discussed:

•   Negotiating Clinical Trial Agreements
•   Negotiating Master Services Agreements with Contract Research Organizations
•   Clinical Trial Compliance

Date / Time: July 11, 2019

•   2:00 pm – 4:00 pm Eastern
•   1:00 pm – 3:00 pm Central
•   12:00 pm – 2:00 pm Mountain
•   11:00 am – 1:00 pm Pacific

Choose a format:

•   Live Video Broadcast/Re-Broadcast:Watch Program “live” in real-time, must sign-in and watch program on date and time set above. May ask questions during presentation via chat box. Qualifies for “live” CLE credit.
•   On-Demand Video:Access CLE 24/7 via on-demand library and watch program anytime. Qualifies for self-study CLE credit. On-demand versions are made available 7 business days after the original recording date and are view-able for up to one year.

Select your state to see if this class is approved for CLE credit.

Choose the format you want.

Clear

Original Broadcast Date: July 11, 2019

Kyle Faget, Esq. is a special counsel and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies. 

Pharmaceutical, Medical Device, and Healthcare Compliance and Counseling

Kyle has been counseling clients on health care regulatory and compliance issues for more than a decade both as an in-house and a private practice attorney. Her practice includes assisting companies to structure, develop, and implement corporate compliance programs suitable for pre-commercial stage and commercial stage pharmaceutical and medical device companies, including drafting core compliance policies and advising on Sunshine Act reporting obligations. She also works with companies to assess compliance risks associated with sales and marketing efforts. In this capacity, Kyle counsels clients on False Claims Act, Civil Monetary Penalties, including beneficiary inducement, and Anti-Kickback Statute issues. Kyle conducts internal investigations and provides clients with strategic and tactical advice regarding government investigations. She has also assisted companies operating under Corporate Integrity Agreements and Deferred Prosecution Agreements and has managed Independent Review Organizations.

FDA Regulatory

Kyle regularly advises pharmaceutical and medical device clients regarding advertising and promotion issues, including off-label promotion. She regularly assesses marketing materials directed toward healthcare providers and direct-to-consumer advertising campaigns for compliance with the Food, Drug, & Cosmetic Act and FDA Guidance documents. Kyle helps clients navigate through the new drug and device approval process.

Clinical Research, Clinical Trials, and Life Sciences

Kyle has extensive experience drafting and negotiating agreements with and for Contract/Clinical Research Organizations and Site Management Organizations. She regularly drafts and negotiates Clinical Trial Agreements, Informed Consents, and other clinical development agreement on behalf of pharmaceutical and medical device clients. Additionally, Kyle has drafted and negotiated a broad swath of operational agreements for her pharmaceutical and medical device clients, including Contract Manufacturing Agreements, Distribution Agreements, Master Services Agreements, and Material Transfer Agreements.

Telemedicine, Telehealth, and Digital Health

Kyle advises suppliers, physician practices, consultants and vendors, and a variety of other health care entities on a range of business, legal and regulatory issues affecting the telemedicine industry. She handles matters involving contracting fraud and abuse compliance, Medicare and Medicaid reimbursement, self-disclosures and overpayments, the Anti-Kickback Statute, physician self-referrals (the Stark Law), health care marketing rules, HIPAA, corporate compliance programs, contracting, confidentiality and information sharing, and policies and procedures.

Accreditation Policy
myLawCLE seeks accreditation for all programs in all states. (Accreditation for paralegals sought thru NALA and NFPA paralegal associations.) Each attending attorney/paralegal will receive a certificate of completion following the close of the CLE program as proof of attendance. In required states, myLawCLE records attorney/paralegals attendance, in all other states attorney/paralegal is provided with the approved CLE certificate to submit to their state bar or governing association.

    Automatic MCLE Approvals

All myLawCLE CLE programs are accredited automatically either directly or via reciprocity in the following states: AK, AR, CA, CT, FL, HI, ME, MO, MT, ND, NH, NM, NJ, NY, WV, and VT. (AZ does not approve CLE programs, but accepts our certificates for CLE credit.)

    Live Video Broadcasts

Live video broadcasts are new live CLE programs being streamed and recorded for the first time. All of these programs qualify for “Live” CLE credit in all states except NV, OH, MS, IN, UT, PA, GA, SC, and LA —these states require in-person attendance to qualify for “Live” CLE credit.

    “Live” Re-Broadcasts

“Live” Re-broadcasts are replays of previous recorded CLE programs, set on a specific date and time and where the original presenting speakers calls in live at the end of the event to answer questions. This “live” element allows for “live” Re-broadcast CLEs to qualify for “Live” CLE credits in most states. [The following states DO NOT allow for “live” CLE credits on re-broadcast CLEs: NV, OH, MS, IN, UT, PA, GA, SC, and LA]

Reciprocity
Many states allow for credit to be granted on a 1:1 reciprocal basis for courses approved in another mandatory CLE jurisdiction state. This is known as a reciprocity provision and includes the following states: AK, AR, HI, CT, FL, ME, MO, MT, ND, NH, NM, VT, NJ, NY, and WV. myLawCLE does not seek direct accreditation of live webinars or teleconferences in these states.