2nd European Clinical Data Disclosure Summit

Day One  Thursday, September 9, 2010

Pre-Conference Workshops
8:00
Registration and Continental Breakfast for Workshop Participants

9:00
Choose Workshop A or Workshop B

Workshop A - Back to the Basics
An Overview of Clinical Trial Disclosure Spanning the History of the Field and Providing a Firm Understanding on the Topic

• An overview of the FDAAA and how trial registration came to be
• An understanding of the framework of Clinical Trial Registry
• Discussion around problems faced in registering clinical trials in multiple countries
• Understanding the practical value to posting clinical trials online
• Basic Methods and best practices for Complaint Disclosure
• Real World Examples

Workshop Leader:
Pat Teden
Principal
TEDEN CONSULTING LLC

Workshop B - Streamlining the Technical Process
Strategies and Tips on the Most Efficient Ways to Register Clinical Trials and Results While Best Utilizing Available Resources

• Automation of XML upload on clinicaltrials.gov and EudraCT
• Solutions to reusing the information already gained in previous trials
• Utilizing internal systems (getting examples on how companies that are ahead of the curve are doing it)
• Overcoming challenges faced with differing requirements and regulations in the various host countries
• Advanced methods and best practices for Compliant Disclosure
• Real World Examples

Workshop Leader:
Merete Joergensen, MSc, MBA
Project Director, Public Access to Clinical Trials
NOVO NORDISK A/S

12:00
Lunch for Workshop Attendees, Registration Opens for Main Conference

13:00
Chairperson’s Welcome

Chairperson:
Jacqueline Sayers
Quality Project Manager
ROCHE PRODUCTS LIMITED

13:05
The European Process
An Overview of the Clinical Trial Process beginning with Gaining Approval for Clinical Trials in Europe and How Trials are Registered with EudraCT

• Learn the beginning to end process of how a clinical trial is currently approved and posted according to directives from EMEA
• What cost implications come with the process of Data Disclosure?
• Requirements for Revised Clinical Trial Data
• An overview of the new Clinical Trial Results format and how it will impact results submissions
• What are the repercussions for not being compliant?

Session Leader:
Detlef Niese, MD, PhD
Head, External Affairs, Global Development
NOVARTIS

14:00
EudraCT Version 8 and Beyond
An In-Depth Look at EudraCT Version 8; What Changes are Included in the New Version as Well as What Changes are Anticipated for Version 9

• What impact will the publication of protocol summaries and results of clinical trials have on drug development?
• How to prepare internal systems to communicate effectively with EudraCT version 8
• How version 9’s expansion of the results database will effect reporting

Session Leader:
Merete Joergensen, MSc, MBA
Project Director, Public Access to Clinical Trials
NOVO NORDISK A/S

14:45
Networking and Coffee Break

15:15
Compliant Global Registration
Discussing the Importance of Ensuring Compliance When Registering in Multiple Countries and Best Practices to do so Efficiently

• Solutions for Managing the Data
• Old vs. New Methods for Managing Information
• Automation and the Outlook for Developing a Standard

Session Leader:
Stephane Gilles
R&D IS - Project Management
SANOFI-AVENTIS

16:00
Registering in the Native Language
Evaluating the Requirements of a National Registry and Strategies for Facilitating Bilingual Registration

• The need for bilingual entries in national registries
• How to facilitate bilingual registration
• The German Clinical Trials Register (DRKS) - A national registry in a global world

Session Leader:
Susanne Jena
Project Manager
GERMAN CLINICAL TRIALS REGISTER

16:45
Roundtables: Emerging Registries
Intimately Discuss the Differences and Intricacies of Each System as well as Improvements to the Framework

Select your preferred Country to discuss in an intimate setting.

• Australia/New Zealand
• France
• Italy

Attendance at roundtables is limited.

17:30
Close of Day One

Day Two  Friday, September 10, 2010

8:00
Continental Breakfast for Conference Participants

8:45
Chairman’s Day Two Welcome

Chairperson:
Jacqueline Sayers
Quality Project Manager
ROCHE PRODUCTS LIMITED

8:55
Roundtable Recap
Moderators from Day One Roundtable Discussions Provide Key Points Addressed

9:30
Updates and Changes to ClinicalTrials.gov
A Showcase Exploring the Update on the Expanded Results Posting in ClinicalTrials.gov and How to Efficiently Utilize the Portal

• Preparing the organization for creating non-technical summaries
• How to interpret the pre-emption clause in FDAAA
• How do changes to ClinicalTrials.gov affect the operational process in drug development?

Session Leader:
Paul Ngai
Principal
180 GLOBAL CONSULTING, LLC

10:15
Networking and Coffee Break

10:45
Health Level 7 Clinical Trial Registration and Results Project
Discussing the Scope and Progress of the HL7 CTR&R Project and Evaluating the Impact of Standardization

• Steps that have been taken to begin the process of standardization among registries
• What learnings have come from exploring the options for implementation?
• Challenges faced along the path for compliant standardization

Session Leader:
Monica Mehta
Director, Regulatory Affairs
GENZYME CORPORATION

11:30
Technology
Leveraging Technology to Support your Clinical Data Disclosure Solutions and a Demonstration of Up and Coming HL7 Clinical Data Disclosure Standardization Freeware

• Trial data disclosure from an IT perspective: What infrastructure needs to be in place?
• Strategies for automating compliant registry and results posting
• Integrating with internal data sources to reduce errors and limit workload
• Utilizing technology to increase compliance

Session Leader:
Thomas Wicks
Business Development Manager
INTRASPHERE TECHNOLOGIES

12:15
Lunch

13:15
Johnson & Johnson Case Study
Optimizing Internal Processes Using Technology to Improve Efficiencies for Clinical Trial Data Disclosure

• Johnson & Johnson has developed a method to automate the fulfillment of clinical trial registration and results disclosure
  •  Technology to transfer data and related information
  • Overview of processes and necessary involvement
  • Best practices

Session Leaders:
Erica F. Schirmer
Global Operations Lead, Clinical Registry
JOHNSON & JOHNSON PHARMACEUTICALS RESEARCH & DEVELOPMENT
&
Rob Middel
Director, Global Operations, Quality Management
JOHNSON & JOHNSON PHARMACEUTICALS RESEARCH & DEVELOPMENT

14:00
The Clinical Trials Registry - India (CTRI)
New Mandatory Registration: Overcoming the Hurdles and Best Practices for Compliant Registration with India’s Clinical Trials Registry

• How to Best Manage the Laws and Staying Informed on Mandates from India
• Learn How Sponsors Can Best Follow India’s Guidelines
  • Language Requirements
  • Data Requirements
  • Posting Requirements and Privacy Laws
• Successfully Complying and Staying Current with CTRI

Session Leader:
Deven Parmar
Vice President, Clinical Research
WOCKHARDT

14:45
Panel Discussion: A Call for Change
Industry Experts Discuss the Need For Change in the Submission Process for Clinical Trial Approval and Results to Ensure Maximum Compliance and Efficiency

• The push for a centralized submission location can greatly relieve confusion in the disclosure process
• Discuss the end goal of changing the EMEA directive which directly influences country laws
• What is the future of Clinical Data Disclosure and how can you help the push for standardization

Moderator:
Detlef Niese, MD, PhD
Head, External Affairs, Global Development
NOVARTIS

Panelists:
Monica Mehta
Director, Regulatory Affairs
GENZYME CORPORATION

Erica F. Schirmer
Global Operations Lead, Clinical Registry
JOHNSON & JOHNSON PHARMACEUTICALS RESEARCH & DEVELOPMENT

15:30
Close of Conference