Attend the only legal program proven to provide the strategies necessary to ensure compliance, mitigate liability, and adhere to Good Clinical Practice whether you are conducting trials in the U.S. or abroad.
From disclosure of physician payments to passage of the HITECH Act and proposed state clinical trial law revisions, conducting and structuring clinical trials has become even more complex over the past year, and will continue to produce new demands and challenges on even the most seasoned professionals in the months to come.
As of press time, record-breaking fines and new enforcement guidelines continue to dominate the headlines as the FDA, DOJ, and SEC continue to pursue greater standards of compliance from the pharmaceutical and medical device industries in an effort to better protect the public health and minimize fraud and corruption both at home and overseas. At the same time, financial pressures are forcing companies to carefully reexamine existing contracts and expenditures, making negotiating agreements and managing relationships with CROs and clinical trial vendors critical to success. Further compounding the complexities are the numerous state, federal, and international laws and regulations that have recently become enacted and can prove exasperatingly difficult to reconcile in pursuit of compliance and transparency.
Through a carefully crafted schedule of panel discussions, networking breaks, and interactive workshops, ACI’s Clinical Trials will show you how to successfully manage these risks and refine your current operations by identifying and incorporating strategies to:
- Streamline online transparency programs and navigate the myriad clinical trial registry laws
- Breakdown HITECH, HIPAA and EU privacy laws and adopt data security provisions into your practice
- Avoid common Medicare reimbursement mistakes and mitigate risks of False Claims Act violations
- Negotiate and draft a “win-win” clinical trial agreement
- Comply with financial disclosure laws and anticipate federal legislation on physician payments to preempt current state regulations
- Demonstrate a commitment to compliance by learning and implementing best practices directly from current and recent federal prosecutors
- Limit liability by proactively including insurance and indemnification terms necessary for specific jurisdictions
- Safeguard IP rights in the U.S. and overseas
- Comply with GCP principles globally and use adverse event reporting to your advantage
Review the schedule to tailor the program with the workshops that best fit your needs and call today! Register today by calling 888-224-2480, fax your form to 877-927-1563, or online at www.AmericanConference.com/Clinical
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