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July 17 18, 2012 | Omni Parker House | Boston, MA

American Conference Institutes 14th Advanced Summit on

Clinical Trials
Ensuring Safe and Compliant Domestic and International Clinical Trials
Benefit from direct FDA and DOJ insight into structuring and conducting compliant clinical trials: Karena Cooper Senior Counsel Office of Regulatory Policy (ORP), CDER Food and Drug Administration (FDA) Mary E. Crawley AUSA Eastern District of Pennsylvania Network with an exceptional faculty of industry experts including: Abbott Laboratories Duke University School of Medicine GE Healthcare Emory University Endo Pharmaceuticals Hospital Corporation of America Johnson & Johnson The Medicines Company MedStar Health Mitsubishi Tanabe Novartis Institutes for BioMedical Research Prometheus Laboratories Rigel Pharmaceuticals University of California, Davis University of Pennsylvania Vidox Willis And many more

Current and former government regulators and enforcers unite with preeminent biopharmaceutical and medical device experts to give you the practical tools to:
UNDERSTAND FDAs current clinical trials enforcement priorities to minimize potential for warning letters stemming from post-marketing studies and investigator reporting PINPOINT common clinical trial activities which may raise a red flag to enforcers and prepare for continued intense DOJ scrutiny MINIMIZE FCPA and anti-corruption risks and enhance human subject protection when conducting international clinical trials SIMPLIFY the informed consent process to be in accordance with good clinical practices (GCPs) when recruiting trial subjects GUARD against litigation risks and class actions stemming from clinical studies through careful trial design AVOID common pitfalls when disclosing clinical trials results and working within the bounds of FDAAA and Sunshine IMPROVE conflict of interest disclosure and management when working with independent review boards (IRBs) REVAMP corporate social media policies to minimize liability while expanding your trials online presence CONDUCT safe and effective biosimilars clinical trials

Plus TWO interactive half-day sessions designed to give you the edge in designing and conducting clinical trials A. Pre-Conference Workshop A: The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials B. Device Manufacturers Working Group Session: Clinical Trials for Medical Device Companies
Media Partners:
Earn

CLE ETHICS
Credits

Register Now 888-224-2480 AmericanConference.com/ClinicalTrials

The FDA recognizes that there have been dramatic changes in how clinical trials are conducted and monitored. Modernize your companys policies and protocols to place your company at the forefront of the quickly evolving clinical trials landscape

WHO YOU WILL MEET


Pharma, Medical Device and Biotech companies: General Counsel Regulatory Aairs Director of Clinical Research Scientic Aairs Compliance Ocers QA/QC Directors Clinical Researchers Members of IRBs CROs Counsel Regulatory Aairs Scientic Aairs Hospitals and Research Institutions Products Liability Attorneys Health Care Attorneys

In the last year, between the issuance of final and proposed regulations on clinical trials conduct and unprecedented government and public scrutiny of trials, structuring and conducting safe and compliant clinical trials has never been a more difficult task. Undoubtedly, there will be even more challenges and new demands on even the most seasoned clinical trials professionals in the months to come. In light of the complexity facing the clinical trials world, ACIs 14th Advanced Forum on Clinical Trials provides a comprehensive forum for the key stakeholders current and former government enforcers, top in-house counsel from sponsor biopharmaceutical and medical device companies, CROS, hospitals, universities, and research institutions to unite and share best practices when structuring a safe and compliant clinical trials program which maximizes data integrity and human subject protection.

More is at stake than ever with record-breaking nes and criminal and civil liability.
The continued and steady stream of high-profi le investigations into biopharmaceutical and device companies clinical studies data integrity makes it abundantly clear that it is imperative to have triage plans in place to weather the storm of criminal and civil liability stemming from clinical trial research.

Successful clinical trials are essential to a companys pipeline and market share. Attendees of this event will:
Hear directly from the FDA and DOJ and several former federal prosecutors on how to guard proactively against impermissible behavior during a clinical trial Heighten patient protection throughout your clinical trials by learning inside compliance tips and strategies from counsel from Hospital Corporation of America, University of Pennsylvania, and more Facilitate drug approval and protect market share as you share best practices with the experts who already have put established large-scale trials together including representatives from Abbott Laboratories, GE Healthcare, Johnson & Johnson, The Medicines Company, Prometheus Laboratories, Rigel Pharmaceuticals and more Gain insider tips to ensure compliance, minimize liability, and adhere to good clinical practices when conducting clinical trials domestically and internationally in the face of new developments with informed consent, post-marketing studies, risk-based monitoring Find out best practices for keeping up to date with numerous scientific and technical advances including the cultural permeation of social media and the reality of biosimilar clinical trials Over the years, previous attendees have demanded even more in-depth information on the logistical and practical challenges of running a trial, so this year we are pleased to present two highly in-depth sessions run by practitioners in the trenches: The Nutsand-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials and Clinical Trials for Medical Device Companies. Dont hesitate- streamlined and safe clinical trials are crucial to the continued success of your company. Call 888-224-2480, fax your registration form to 877-927-1563 or register on-line at www.AmericanConference.com/ClinicalTrials to ensure that you have a spot among your peers at this summit of the leaders in the clinical trials industry.

Continuing Legal Education Credits


Accreditation will be sought in those jurisdictions requested Credits by the registrants which have continuing education requirements. Th is course is identified as nontransitional for the purposes of CLE accreditation.
Earn

CLE

ACI certifies that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board in the amount of 15.0 hours, of which 1.0 will apply to Ethics. An additional 4.0 credit hours will apply to workshop A participation and 3.5 credit hours will apply to workshop B participation. ACI certifies that this activity has been approved for CLE credit by the State Bar of California in the amount of 12.75 hours, of which 1.0 will apply to Ethics. An additional 3.5 credit hours will apply to workshop A participation and 3.0 credit hours will apply to workshop B participation. You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held. ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request. Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

PRECONFERENCE PRIMER
Monday, July 16, 2012 | 1:30 pm 5:00 pm (Registration begins at 1:00 pm)
The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials
Harvey J. Altman, Ph.D. Executive Director and Head, Clinical Operations Mitsubishi Tanabe Pharma Development America, Inc. (Warren, NJ) J. Benneville (Ben) Haas Partner Latham & Watkins LLP (Washington, DC) Marialuisa S. Gallozzi Partner Covington & Burling LLP (Washington, DC) David E. Shuey, ARM North America Practice Leader Life Sciences Willis (Radnor, PA)

Whether you are new to clinical trials or need a refresher, this course will give you the practical knowledge necessary to combat the logistical difficulty in organizing large-scale operations and master the myriad of rules and requirements associated with running clinical trials across multiple jurisdictions. In this highly interactive guided pre-conference workshop, hear expert practitioners give concrete and practical tips to get clinical trials up and running smoothly, quickly, and most importantly, successfully. Get a jumpstart on the issues that will be addressed in even greater depth throughout the conference such as: Preventing delays in start dates through a global controlled master program Determining where to locate the trial What are the drop-dead dates for starting the trial? Getting beyond the clinical trial agreement: handling the somewhat voluminous paperwork necessary to get a clinical trial up and running Negotiating IRB and site agreements Negotiating data agreements Negotiating EU representative agreements in international clinical trials Putting compliance and training mechanisms in place to avoid FDA and FCPA enforcement when working with subcontractors and vendors Finding and recruiting required numbers of patients with adequate health profi le at reasonable cost Ensuring data privacy under HIPPA: Protecting the security of protected health information (PHI) in the digital age Abiding by the new EU data privacy directive Managing recordkeeping including clinical trial registries and study data Including key insurance provisions and essential contractual indemnity to minimize liability when conducting clinical trials Complying with disparate insurance requirements: a country-by-country guide to what sponsors must have in place Working with CROs in designing, implementing and managing clinical trials Negotiating with CROs when contracting with sites, investigators, and vendors Doing more with less resources: a look at the business basics in vendor/CRO relationships Managing expectations in advance in order to protect parties respective rights in the contract Who has access to the results? Who ultimately bears the responsibility for errors? This workshop aims to give practitioners in the trenches the crucial information necessary to combat logistical and practical problems inherent in being responsible for organization and execution of large-scale clinical trials.

American Conference Institute:


The leading networking and information resource for counsel and senior executives. Each year more than 21,000 in-house counsel, attorneys in private practice and other senior executives participate in ACI events and the numbers keep growing. Guaranteed Value Based on Comprehensive Research ACIs highly trained team of attorney-producers are dedicated, fulltime, to developing the content and scope of our conferences based on comprehensive research with you and others facing similar challenges. We speak your language, ensuring that our programs provide strategic, cutting edge guidance on practical issues. Unparalleled Learning and Networking ACI understands that gaining perspectives from and building relationships with your fellow delegates during the breaks can be just as valuable as the structured conference sessions. ACI strives to make both the formal and informal aspects of your conference as productive as possible.

Global Sponsorship Opportunities


With more than 500 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world. As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation. For more information about this program or our global portfolio of events, please contact: Wendy Tyler Head of Sales, American Conference Institute Tel: 212-352-3220 x5242 | Fax: 212-220-4281 w.tyler@AmericanConference.com

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

DAY ONE: Tuesday, July 17, 2012


7:15 8:15

Registration and Continental Breakfast Co-Chairs Opening Remarks


J. Benneville (Ben) Haas Partner Latham & Watkins LLP (Washington, DC) Priya Mannan JD LLM Executive Director Associate General Counsel & Global Compliance Officer Novartis Institutes for BioMedical Research, Inc. (Cambridge, MA)

8:30

Maintaining FDA Audit Readiness: Compliance in Post-Marketing Studies, Investigator Reporting and Beyond
Karena Cooper, J.D., M.S.W. Acting Associate Director of Policy and Communication and Regulatory Counsel Office of Scientific Investigations (OSI), CDER United Stated Food and Drug Administration (FDA) (Silver Spring, MD) Katherine OBrien Counsel Abbott Laboratories (Chicago, IL) Maria Kennedy Assistant General Counsel Office of the General Counsel Johnson & Johnson (New Brunswick, NJ) Exercise of FDAs authority to enforce requirements that sponsors conduct FDCA Section 505(o)(3) postmarket studies and clinical trials FDA/CDERs February 2012 Notice to Industry FDA/CDER Warning Letter citing sponsor for noncompliance with FDCA Section 505(o)(3) postmarketing requirement FDAs draft guidance on risk-based approaches to monitoring clinical investigations Demonstrating your compliance initiatives in managing relationships and record keeping and responding to warning letters about your clinical investigations

Determining and complying with state clinical trial result disclosure requirements Setting a timeline for results disclosure Adopting audit and monitoring processes for results posting Exploring the difficulties in complying with payment disclosure requirements Preparing for large-scale reporting of payments to healthcare professionals under the Sunshine Act When must you report a clinical trial payment to a physician or investigator? Creating a consistent system to track the myriad payments to healthcare providers during a trial in order to track potential confl icts Who in your organization is responsible for reporting? Avoiding the auspices of impropriety when disclosing payments to physicians and investigators Determining when to report payments to physicians under the particular challenges of Massachusetts, Vermont and Maine state laws Reconciling varying and sometimes confl icting state law disclosure requirements regarding payments made during clinical trials Complying with NIH Final Rule disclosure requirements and lowered monetary threshold

11:15

Complying with Revamped FDA Conicts of Interest Guidance When Selecting and Working with Independent Review Boards
Angelique P. Dorsey, J.D., CHRC Research Compliance Director MedStar Health (Columbia, Maryland) Preparing for continuing IRB review post-clinical trial approval in keeping with the FDAs fi nal guidance post-clinical investigation approval What will be required from sponsors and researchers in terms of criteria and frequency of post-approval review? When will expedited review be possible? Communicating with IRBs throughout the continuing review period Exploring potential red flags for enforcement: an overview of recent FDA warning letters to IRBs Properly and thoroughly vetting potential IRBs Examining the trend towards for-profit IRBs How are independent and for-profit IRBs taking steps to reduce conflict? Complying with the lowered NIH monetary threshold for investigator conflicts of interest disclosure Determining when to disclose a potential confl ict Ascertaining and differentiating between actual and perceived financial conflicts of interest when working with IRBs What is considered fair market value when compensating IRBs? Arguing against the appearance of impropriety when working with one IRB on many studies Obtaining AAHRP accreditation for an IRB

9:45 10:00

Morning Networking Break Promoting Transparency in Clinical Trials: Bracing for the Dual Impact of Sunshine and FDAAA on Disclosure and Reporting
Christopher Eliopulos Associate General Counsel GE Healthcare (Wauwatosa, WI) Robyn S. Shapiro Partner Drinker Biddle & Reath LLP (Milwaukee, WI) Exploring the difficulties in complying with clinical trial results disclosure requirements Determining who is a responsible party for reporting under FDAAA rules Determining and complying with ICMJE clinical trial disclosure requirements

12:30

Networking Lunch

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

1:45

Identifying Potential High-Risk Areas to Minimize Future Products Liability Stemming from Clinical Trials
Loren H. Brown Partner DLA Piper (New York, NY) Charlene A. Gallagher Principal Gallagher Consulting (Philadelphia, PA) Limiting litigation exposure: what can sponsors do to protect themselves during their clinical trial to avoid product liability later? Assessing potential product liability when analyzing reported adverse events during a clinical trial Will the fi nancial interest of doctors conducting the study withstand a close look? Strategies for defeating failure to warn cases premised on clinical trials data Examining the trend of subpoenaing clinical trial records for products liability causes of action Discovery in the electronic age: how to best structure your emails and prepare CR&D staff to anticipate such review Potential exposure arising out of globalization of clinical trials current trends Combating a PR nightmare in the case of a clinical trial incident or scenerio Monitoring the safety of study participants: structuring and facilitating oversight of and communication with CROs and sites

S. David McLean, Jr. Associate General Counsel, Office of the General Counsel Emory University (Atlanta, GA) Adam P. Rifkind Associate Director, Pre-award Office of Research Services University of Pennsylvania (Philadelphia, PA) H. Gilbert Smith, Ph.D Associate Dean & Managing Director Office of Corporate Research Collaborations Duke University School of Medicine (Durham, NC) Understanding the differing missions and goals between industry and academia Factoring in universities charitable and academic missions Safeguarding IP protection and ownership rights for data gathered during clinical trials Understanding the obligations of a non-profit under the Internal Revenue Code Structuring your clinical trial agreement so that ownership of intellectual property is clear Allocating data ownership and use rights Addressing ownership and access to biological samples Disposition of rights to inventions Considerations around publication Negotiating confidentiality agreements for potential principal investigators to review the protocol to determine whether to participate in the clinical trial

5:15

Conference Adjourns to Day 2

2:45

Safely Conducting Biosimilars Clinical Trials: Understanding FDAs Requirements for Biosimilar Clinical Trials
Brian J. Malkin Partner Frommer Lawrence & Haug LLP (New York, NY) How will FDA take a selective and targeted approach to requiring clinical trials? How much and what kind of data should prudent companies generate and include? Demonstrating biosimilarity: what will the FDA require from trials? Extrapolating data obtained in clinical trials for a reference product to support biosimilar applications Relying on clinical trial data provided by ex-U.S. companies for comparator products Evaluating the potential for citizens suits when evaluating safety and efficacy for complex and multifaceted molecules Biosimilar reviews: anticipating whats new in the clinical trials arena and what is familiar How FDA will review a 351(k) submission? Following a hypothetical 351(k) submission Framing the risks and benefits in this nascent area

DAY TWO: Wednesday, July 18, 2012


8:00 8:45 9:00

Continental Breakfast Co-Chairs Opening Remarks and Recap of Day 1 DOJ Enforcement Spotlight: Steering Clear of Corporate and Individual Liability When Conducting Clinical Trials in an Era of Heightened Scrutiny
Mary E. Crawley Assistant United States Attorney Eastern District of Pennsylvania (Philadelphia, PA) Deborah A. Logan, Esq. Sr. Counsel, Research & Development Endo Pharmaceuticals Inc. (Chadds Ford, PA) Anticipating which activities during a clinical trial may raise a red flag to enforcers based on recent investigations Failing to report adverse events during a trial Falsification of clinical trial data in new drug applications (NDAs) Falsifying medical research Engaging in promotional activities relating to the clinical trial Kickbacks to clinical trials investigators Examining the incentive for whistleblowers suits in the pharmaceutical and biotech industry Examining the trend towards individual rather than corporate accountability Subcontractors and investigators potential liability

3:30 3:45

Afternoon Refreshment Break Working with Academic Medical Centers on Clinical Trial Agreements
Andrew Jones Clinical Trials Contracts Analyst, Health System Contracts University of California, Davis (Sacramento, CA)

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

Exploring prosecutorial tools to pursue False Claims Act liability for wrongful conduct in connection with clinical trials When does a misstatement of clinical trial data about the efficacy of a drug for off-label use become criminal? How does this intersect with First Amendment rights post Sorrell & Coronia? Implementing compliance plans to guard against corporate and individual liability Training employees and contractors about the ins-and-outs of compliance with good clinical practices Coordinating your legal, compliance and audit departments to have internal investigation mechanisms in place Self-reporting of problem data

Understanding cultural differences and obtaining informed consent for women in traditionally patriarchal culture Recruiting patients in light of negative publicity surrounding trials

11:30

Focus on Established Markets: Conducting Clinical Trials in the EU


Complying with revamped data protection laws and privacy policies under the EU directive Registering foreign trials Appointing a legal representative to establish a local presence Communicating with both the FDA and the EMA when monitoring foreign clinical trials to ensure that all required procedures are followed to protect data integrity Avoiding duplicative efforts in your disclosures to both authorities Understanding the certain prospect of increased monitoring and OIG oversight for trials conducted abroad Working in countries with a robust anti-corruption scheme in place Examining the implications of the UK anti-bribery statute in the clinical trials arena Determining whether parent companies or sister affi liates will be covered under the UK Bribery Act if they have matrix organizations Understanding the individual country requirements when conducting trials in the EU Update on new regulatory developments affecting clinical trials in the EU Coordinating trials and understanding timelines in multiple EU countries concurrently

10:00

Morning Coee Break SPOTLIGHT SESSIONS: Conducting Clinical Trials Internationally: Protecting Human Subject and Data Integrity in Emerging and Established Markets

10:15

Minimizing Risk and Adhering to the FCPA Mandates when Conducting Clinical Trials Abroad
Sergei Drapkin, MD, PhD, MBA Senior Director Vidox Consulting (Luxembourg, EU) Daniel Kaufman Senior Director Global Contracting and Business Ethics The Medicines Company (Parsippany, NJ) Steven S. Michaels Partner Debevoise & Plimpton LLP (New York, NY) Complying with anti-corruption and anti-kickback laws when running clinical trials in a state-owned economic sector Identifying who may be considered a government official Increasing study enrollment while steering clear of FCPA impropriety with the commonly accepted practice of referral payments to physicians Giving gift s and adhering to culturally accepted standards for politeness without violating anti-corruption laws Including provisions in the clinical trial agreement to structure funding and payments in accordance with FCPA requirements Strengthening your compliance program when working in high risk markets Understanding the evolving regulatory framework companies conducting clinical trials in emerging markets must abide with in: Russia India China Latin America Diligently monitoring CROs and other third parties Overcoming the difficulties inherent to performing clinical trials in rural areas

12:15 1:30

Networking Luncheon Understanding the Nuances of Medicare Secondary Payor Rules Relating to Injuries Arising out of Clinical Trials
Ryan D. Meade Partner Meade & Roach LLP (Chicago, IL) Eve M. Brunts Partner Ropes & Gray LLP (Boston, MA) Understanding how Medicare secondary payer rules apply to research sponsors and clinical sites What type of injury or complication triggers the rules? What type of subject injury language can have unintended consequences for clinical sites? Reporting payments for subject injuries under new reporting obligations Who qualifies as a responsible reporting entity (RRE) to trigger the rules? What guidance has CMS provided on meeting RRE obligations? Incorporating subject injury language responsive to Medicare MSP rules in clinical trial agreements and informed consent documents What should research sponsors be doing to ensure that clinical sites and subjects provide the information needed to meet obligations?

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

2:30

Friending Your Clinical Study Subjects: Exploring Social Media as a Platform for Patient Recruitment
Maria D. Buckley Of Counsel Nutter McClennen & Fish LLP (Boston, MA) Priya Mannan JD LLM Executive Director Associate General Counsel & Global Compliance Officer Novartis Institutes for BioMedical Research, Inc. (Cambridge, MA) Utilizing Facebook and other social networking sites to increase visibility of your trial and apply to a broader range of potential study subjects What can you say without entering the realm of marketing (on-label and off-label)? Weighing the effect of comments made on Facebook group message boards regarding efficacy of the drug Should this count as knowledge of adverse events? Factoring in FDAs draft guidelines on responding to unsolicited requests via social media Using classified ads on web sites to recruit participants for clinical trials Avoiding the perception of soliciting clinical trials study subjects with coercion of payment Exchanging ideas about using Twitter as a means for recruitment Creating a virtual presence and putting a comprehensive social media policy for the trial Using clinicaltrials.gov effectively to register both the trial and the results under FDAAA Navigating and utilizing the new NIH Clinical Trials and You website Creating a policy about participants use of Facebook and Twitter during the trial

Demonstrating drug efficacy in a variety of treatmentnave ethnic populations and the ensuing benefits to your research and development pipeline Using translation services for informed consent forms: the importance of steering clear of meaningful differences in dialect What risks do companies face if the consent is not informed? Secondary use of specimens and data- what is legal and what is ethical? What is your obligation to identify or strip data garnered in a clinical trial? Identifying the rights of the clinical trial subject as to biobanking and incidental fi ndings in clinical research in light of increased sophistication in genetic testing and unprecedented access to genetic material What is your obligation to tell a subject that you have made a fi nding incidental to research? If there is an obligation to disclose how long does this last?

ETHICS 5:00

Main Conference Adjourns

Device Manufacturers Working Group Session


Thursday, July 19, 2012 | 9 am 12 pm (Registration 8:30 am)

Clinical Trials for Medical Device Companies


In this highly collaborative session exclusive to medical device manufacturers, attendees will have the unique opportunity to interact with their device peers and colleagues to apply the concepts learned over the past two days and delve more deeply into the specific concerns and challenges that arise during a medical device clinical trial. Points of discussion include: Analyzing how changes to the 510(k) process and the increased clinical studies therein will impact your current clinical trials procedures and protocols Exploring the EMAs new approaches to clinical trials for devices Defining the scope of permissible Medicare coverage for subject injuries arising out of device trials Mastering the CMS code system to meet technological advances in invasive and non-invasive devices Responding to CDRHs increased post-market vigor and avoiding fines and penalties through compliant post-market studies and policies Addressing specific privacy and patient recruitment concerns associated with device clinical trials Overview of the international regulations, customs and best practices relevant for medical devices in order to reduce risks and produce meaningful reliable date for marketing approval Identifying key provisions to include in the clinical trial agreement that address the particular concerns of a device company Best practices for managing a device clinical trial from start to finish

3:30 3:45

Afternoon Refreshment Break Complying with Good Clinical Practices When Conducting Clinical Trials: Informed Consent, Secondary Use of Data and Beyond
Adela C. Enochs-Ochoa Executive Director, Legal Rigel Pharmaceuticals, Inc. (San Francisco, CA) Jenny Alonso Senior Director, Clinical Affairs and Compliance Officer Prometheus Laboratories (San Diego, CA) David Vulcano, LCSW, MBA, CIP, RAC AVP & Responsible Executive for Clinical Research Hospital Corporation of America, Inc. (Nashville, TN)

ETHICS

Mitigating risk and minimizing exposure to liability by properly obtaining informed consent Beyond the form itself: understanding the process of informed consent How can sponsors protect themselves from risk when not directly obtaining consent? Securing informed consent in traditionally patriarchal and tribal cultures Obtaining proper informed consent to facilitate pediatric drug discovery Pledging human subject protection and data validity when conducting international clinical trials

American Conference Institute, 2012

Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/ClinicalTrials

July 17 18, 2012 | Omni Parker House | Boston, MA

Hear from an unparalleled faculty of legal and regulatory clinical research professionals:
Abbott Laboratories The Clinical Technology Transfer Group Covington & Burling LLP Meade & Roach The Medicines Company MedStar Health Mitsubishi Tanabe Novartis Institutes for BioMedical Research, Inc. Nutter McClennen & Fish LLP Prometheus Laboratories Rigel Pharmaceuticals Ropes & Gray LLP University of California, Davis University of Pennsylvania Vidox Willis

American Conference Institutes 14 Advanced Summit on

th

Debevoise & Plimpton DLA Piper Emory University Endo Pharmaceuticals Inc. Frommer Lawrence & Haug Gallagher Consulting GE Healthcare Hospital Corporation of America Johnson & Johnson Latham & Watkins LLP

Clinical Trials
Ensuring Safe and Compliant Domestic and International Clinical Trials

R E G I S T R AT I O N F O R M
PRIORITY SERVICE CODE
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Registration Fee
The fee includes the conference all program materials continental breakfasts lunches and refreshments.

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Payment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization.

Cancellation and Refund Policy


You must notify us by email at least 48 hrs in advance if you wish to send a substitute participant. Delegates may not share a pass between multiple attendees without prior authorization. If you are unable to find a substitute, please notify American Conference Institute (ACI) in writing up to 10 days prior to the conference date and a credit voucher valid for 1 year will be issued to you for the full amount paid, redeemable against any other ACI conference. If you prefer, you may request a refund of fees paid less a 25% service charge. No credits or refunds will be given for cancellations received after 10 days prior to the conference date. ACI reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or other costs incurred by registrants. No liability is assumed by ACI for changes in program date content speakers or venue.

ATTENTION MAILROOM: If undeliverable to addressee, please forward to: Director of Clinical Trials; General Counsel; Corporate Counsel; Regulatory Counsel CONFERENCE CODE: 723L12-BOS YES! Please register the following delegate for 14th Advanced Summit on Clinical Trials

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American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the ACI-Clinical Trials conference to receive this rate: Venue: Omni Parker House, Boston Address: 60 School Street, Boston MA, 02108 Reservations: (617) 227-8600 or (800) THE-OMNI

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