FDAnews Announces Clinical Trials Disclosure and Transparency Summit

FALLS CHURCH,  Va., June 13, 2013 /PRNewswire-iReach/ --

Clinical Trials Disclosure and Transparency Summit
**Presented by FDAnews**
July 23-24, 2013Bethesda, MD

(Photo: http://photos.prnewswire.com/prnh/20130613/CG31191)

Register NOW and find out what you need to know and do to handle the FDA and EMA's new stepped-up enforcement of Clinical Trial Disclosure requirements … Discover best practices for meeting current disclosure requirements … and Stay on the cutting edge of today's rapidly changing new trends and developments in Clinical Trials Disclosure.

Plus, network with leading clinical trial professionals, government regulators and legal experts from the U.S. and Europe.

Register Now

Conference Chair:
Peter Pitts,
President, Co-founder, Center for Medicine in the Public Interest

Keynote Speakers:
Dr. Janet Woodcock,
Director, CDER, FDA
Sir Alasdair Breckenridge, Chair, Emerging Science and Bioethics Advisory Committee, Department of Health, UK; formerly Chairman, Medicines and Healthcare Products Regulatory Agency, UK

Virtually every clinical trials professional in the U.S. and Europe is hit dead center by the tougher new FDA and EMA disclosure and transparency requirements for clinical trials.

For starters, both the FDA and the EMA have already stepped up enforcement of current clinical trial disclosure and transparency requirements.  Failure to report — or to report correctly and completely — can now result in loss of funding from many government agencies.

But that's just the tip of the iceberg:

Professional publications are calling for increased reporting and disclosure … patient advocacy groups are calling for the disclosure of all clinical trial results through AllTrials.com … and Congress and the White House are growing more aggressive in mandating expanded reporting for all clinical trials done through government agencies.  

Join us at Clinical Trials Disclosure and Transparency Summit, July 23-24 and GET answers to many of the toughest questions you now confront as a clinical trials professional.  

You are invited to participate in a unique Summit that brings together leading professionals in the clinical trials industry, including clinical trials operations and medical affairs professionals, government regulators, prominent legal experts and many others to discuss, debate, analyze and uncover the latest priorities, expectations and best practices for improving clinical trials disclosure and transparency.

Register Now

Here's just a sample of the help you get at the Summit:

  • An overview of recent legal and regulatory developments that affect both the legal obligations and day-to-day responsibilities of the clinical trials professional
  • Clear analysis of current regulatory and non-regulatory reporting obligations … and look at where requirements are going in the near, mid and longer term
  • What you need to know now about current enforcement actions … including how any agency of the HHS can now withhold funding grants for trials currently in progress until disclosure requirements are met … and how these agencies can also cut off future grants to companies or organizations that it feels are not in compliance
  • A close-up look at how the growing chorus of calls by the editors of medical journals for complete clinical (or raw) data transparency could forever upset the peer review and publishing landscape
  • How to ensure general adoption of established quality standards of meta-analyses and other types of (confirmatory) data re-analysis that may warrant regulatory action
  • The importance of establishing clear rules of engagement that provide balance between sponsor concerns and public health benefits
  • And much more!

Plus, leading clinical trials experts will discuss and answer for you many of today's most critical questions, including:

  • Can all stakeholders develop and agree upon adequate standards for protection of personal data when publicizing complete datasets?
  • Could there be a silver lining in this?  Might full disclosure of patient-level data help you to expose weaknesses or nuances in your competition's product or procedures that you could use to your advantage? 
  • What will happen to advertising and promotion strategies if all data is laid bare?
  • What are the possible problems and best steps to take if you've got a "dud" in your portfolio that would be exposed upon re-examination/analysis of patient-level data?
  • How could the impact of full disclosure down the line affect your immediate and future trial design and endpoint discussions?
  • What is the current status of the disclosure efforts undertaken by the GSK and how could these steps affect your  company?

And that's just a sample!  You'll also take a close look at what steps the current administration is taking or might take to increase reporting … what leading publications are doing to require reporting … and many other critical trends and developments in clinical trial reporting that you need to know about now.

Register Now

Here are just a few of the speakers you'll meet:

  • Dr. Deborah Zarin, Director, ClinicalTrials.gov
  • Dr. Robert Temple, Director, Office of Medical Policy, CDER, FDA (invited)
  • Dr. Joseph Ross, Co-Investigator, Yale Open Data Access Project (YODA), Yale University
  • Dr. Lisa Schwartz, Co-Director, The Center for Medicine and the Media, The Dartmouth Institute for Health Policy and Clinical Practice
  • Dr. Gregory Curfman, Executive Editor, New England Journal of Medicine
  • Dr. Steven Woloshin, Director, The Center for Medicine and the Media, The Dartmouth Institute for Health Policy and Clinical Practice
  • Dr. Phil Fontanarosa, Executive Editor, JAMA
  • Dr. Jose Merino, Research Editor, British Medical Journal
  • Dr. Christine Laine, Editor, Annals of Internal Medicine
  • Dr. Jesse Berlin, Vice President, Pharmacoepidemiology, Johnson & Johnson Pharmaceutical Research and Development (invited)
  • Jessica Gilbart, President and CEO, Lupus Foundation of America
  • Dr. Garry Neil, Partner, Apple Tree Partners; formerly Corporate Vice President, Science & Technology, Johnson & Johnson (invited)
  • Christopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, Virtify
  • Dr. Bruce Haffty, Associate Editor, Journal of Clinical Oncology
  • Susan Randall, Senior Director of Science and Education, National Osteoporosis Foundation (invited)
  • Louise Vetter, CEO, Huntington's Disease Society of America (invited)

 Who should attend:

  • Clinical Research Directors
  • Medical Affairs Directors
  • Regulatory Affairs
  • Legal and Compliance Officers
  • Consultants/Service Providers

Clinical Trials Disclosure and Transparency Summit
**Presented by FDAnews**
July 23-24, 2013Bethesda, MD


Early Bird (until June 23, 2013):
Corporate Rate: $1,697 per attendee
Gov't/Nonprofit/Academic: $1,197 per attendee

Regular Rate (after June 23, 2013):
Corporate Rate: $1,997 per attendee
Gov't/Nonprofit/Academic: $1,497 per attendee

3 Easy Ways to Register

Online:     www.fdanews.com/ClinicalTrialDisclosure
By phone: 888-838-5578 or 703-538-7600
Fax:        703-538-7676

Media Contact:

Jeff Grizzel FDAnews, 703-538-7668, jgrizzel@fdanews.com

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