The statistics show that the clinical trials industry is booming, but public scrutiny of clinical trials sponsors and the potential for government enforcement is at an all time high. Now is the time to attend the one event where government insiders, top corporate counsel, and industry leaders come together to teach you the necessary strategies to ensure compliance, minimize risk and liability, and adhere to good clinical practices when conducting clinical trials in the U.S. or abroad.In response to the complexity facing the clinical trials industry in this tumultuous climate, ACI s 13th Advanced Forum on Managing Legal Risks in Structuring and Conducting
Clinical Trials 2011 in the U.S. and Abroad provides a forum for all the key stakeholders- current and former government enforcers, top in-house counsel from pharmaceutical and medical device companies, hospitals and research institutions, and leading industry practitioners- to come together and share insights and practical tips you can implement now in order to structure a compliant clinical trials program. In this time of stepped-up enforcement by regulatory agencies and the Department of Justice (DOJ), companies must be vigilant about protecting human subjects and data validity, especially in jurisdictions where there is less regulation. It is more difficult than ever before to develop a strategic clinical trials program that maximizes data integrity and minimizes exposure to risk, and yet is also more critical to do so, in the face of the major uncertainty the clinical trials industry faces both domestically and internationally.
Clinical trial agreements simply must comply with good clinical practices, or companies can face audits leading to staggering civil penalties and even individual criminal punishment for any wrongdoers who do not abide by the rules. Hear from the experts who have already put established tactical plans for implementing large-scale clinical trials in place, and hear from the current and former enforcers who can help troubleshoot problem areas within clinical trials compliance. More is at stake than record-breaking fines and criminal and civil liability: successful clinical trials are crucial to a company s pipeline and market share. By teaching how to further develop good clinical practices, this conference will help you protect and increase revenue in this volatile economic climate.
Our expert faculty of top-level lawmakers and industry policy setters will provide you with proven-effect strategies to:
- Understand the FDA s and the DOJ s stepped-up enforcement priorities and avoid audits through a strong commitment to compliance;
- Comply with evolving and increasingly more active regulatory frameworks in a broad swath of foreign markets and minimizing (FCPA) and global anti-corruption risks when conducting trials internationally;
- Recruit clinical trial subjects and obtain valid informed consent domestically and globally;
- Navigate myriad conflicting and somewhat confusing state and federal clinical trial disclosure and privacy laws and build a consistent reporting system in light of the trend towards requiring greater transparency in clinical trials data and funding;
- Demystify Medicare secondary payer issues and clarify the challenging guidance related to key issues such as liability arising out of clinical trials; and
- Negotiate key clinical trial agreement terms including insurance, indemnity, and ownership clauses to safeguard intellectual property rights and mitigate liability
Complement your training by attending our hands-on, finely detailed workshops and master classes about the mechanics of setting up successful clinical trial programs:
Pre-Conference Workshop: The Nuts-and-Bolts of Running Large-Scale Clinical Trials 2011 Across Multiple Jurisdictions
MONDAY, JANUARY 24, 2011: 2:00 PM 5 PM
Post-Conference Master Classes: Focus on Emerging Regions: Navigating the Complicated Regulatory and Legal Frameworks in Latin America, Russia, India and China Conducting Clinical Trials 2011 in Latin America: Challenges and Opportunities
THURSDAY, JANUARY 27, 2011: 9:00 AM 12 PM
Protecting Human Subject and Data Integrity When Conducting Clinical Trials 2011 in Russia, India, and China
THURSDAY, JANUARY 27, 2011: 2:00 PM 5 PM
Formulate innovative solutions for crafting and negotiating clinical trial agreements that will boost profits and ensure data validity, and most importantly, subject safety. Register today by calling 888-224-2480, fax your form to 877-927-1563, or register online
