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Clinical Trials Transparency 3-Part Series: Moving the Debate Forward-Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 2-Connecting the Research Community: Data Sharing–Perspectives from Academia and Patient Advocacy Groups

Oct 21 2014 11:00AM - Oct 21 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


Series Overview

Providing greater access to clinical trial data has a number of benefits including facilitating further research to advance medical science and improve patient care. To deliver these benefits and respond to calls for greater transparency regulators, industry professionals, and academics have looked to create and frameworks for data sharing. These initiatives raise questions around appropriate mechanisms for improved openness and transparency, new data-use, privacy, and operational and infrastructure challenges.

DIA is presenting a three-part webinar series on Clinical Trial Transparency, which will begin with “Paving the Way for Greater Access to Data” a discussion focused on the benefits and concerns surrounding  greater access to clinical trial data such as how to facilitate further research and address concerns around privacy and legitimate re-use..  In our second installment, the focus will shift to “Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy Groups.” This discussion will place an emphasis on the opportunities and challenges to providing access to data from clinical trials conducted outside of industry. This will include the potential for developing a bridge between academia and industry frameworks for data access. Finally, this series will conclude with, “Understanding the Legislative Landscape: Regulatory Updates from the FDA and EMA,” taking a closer look at US and EU legislative requirements to include perspectives from the FDA and EMA on current and future initiatives.


Part 2 - Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy Groups

Many clinical trials are conducted outside of industry. In 2012, more than 330 clinical trials were registered every week with the international ClinicalTrial.gov register, with the vast majority conducted in academic centers and sponsored either by government or funded internally by the academic organization . In Europe, at least 20% of trials conducted have non-industry sponsors.

This webinar will focus on the perspectives from academia and patient groups on the opportunities and challenges associated with providing and gaining access to data for further research and will address questions such as:  How would the additional data and information be used by academic researchers and patient groups?, What efforts are currently underway to share data from non-industry trials?, and What opportunities exist or could be created to achieve greater alignment in data sharing activities across academia and industry?

Featured Topics

  • The Patient Perspective: Assess to Their Clinical Trial Data
  • Using and Sharing Data
  • Developing a Framework for Greater Data Sharing Across Academia and Industry

View Series Part 1 and Part 3

Part 1 - Paving the Way for Greater Access to Data

Part 3 - Understanding the Legislation Landscape:  Regulatory Updates from the FDA and EMA

Who Should Attend 

Professionals involved in:

  • Academia
  • Clinical Operations
  • Clinical Research
  • Clinical Safety and Pharmacovigilance
  • Clinical Statistics
  • Clinical Trials
  • Data Management
  • Ethics
  • Government Agencies
  • Medical Affairs
  • Patient Advocacy
  • Quality Assurance
  • Quality Risk Management
  • Regulatory Affairs
  • Registry Management
  • Research and Development
  • Safety Regulation

 

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss efforts currently underway to share data from non-industry trials and patient groups.
  • Describe how greater access to data could be used by academic researchers
  • Differentiate between current industry and academia frameworks for providing  access to clinical trial data

Special Offers 

Series Discount Available*

Buy 2 webinars in this series
and save 10%
Buy the whole series
and save 15%
*Order must be placed in one transaction for savings to be applied

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

For more information
Meredith Kaganovskiy, Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199
Meredith.Kaganvoskiy@diahome.org

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442. 6149
Fax +1.215.442.6199
Stephanie.Ritter@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 1 Elective Units • Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Units
• Regulatory Affairs Certificate Program: 1 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Part 2 - Connecting the Research Community IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Tuesday, November 4, 2014.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

Series Discount Available*
Buy 2 webinars in this series and save 10%
Buy the whole series and one webinar and save 15%
.
*Order must be placed in one transaction for savings to be applied.


  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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