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2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle - Part 2: DILI Biomarkers: Where Are We and Where do We Need to Go?

Dec 5 2012 10:00AM - Dec 5 2012 12:00PM | Online

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Overview 

Series Overview:

In this two-part webinar series distinguished global panel members from academia, industry and the Food and Drug Administration (FDA) will discuss the pitfalls and potential solutions in drug-induced liver injury (DILI).  One of the main reasons for withdrawal of a marketed product or non-approval of a new compound is DILI. The key issue is the assessment of DILI causality. Part 1 of this webinar series will focus on how one should proceed with causality assessment. Is there a gap in the understanding between the regulators and industry? Is there a common language of assessment between key regulators like FDA, European Medicines Agency (EMA)?   In Part 2 of this series we will discuss the new tools in DILI Biomarkers This Webinar series is specially designed to host a mini-town hall session at the end of each webinar. The speakers and panel experts will address very important issues raised by the attendees particularly from industry. Please forward critical questions or issues via email to DILIwebinar@diahome.org in advance.


Overview Part 2:

DILI Biomarkers is a real puzzle to the entire scientific community.   In this webinar regulators and industry will come together to present new thoughts and tools about biomarkers.  This webinar will provide up to date, relevant and current information about DILI that will help the industry to move forward their compound from pre-clinical to clinical. In this webinar participants will gain an understanding of the limitation and scope of such tools. The recent advancements made will be instrumental for industry to readjust their process for better handling their products with suspected DILI. Join us and share your thoughts about DILI Biomarkers with the leading global experts.  Please email your DILI related questions, thoughts and ideas in advance of the webinar to DILIwebinar@diahome.org

Featured Topics 

  • Predicting Serious DILI: Search for Biomarkers
  • Update on Predictive Safety Testing Consortium (PSTC) Hepatotoxicity Working Group
  • A New Tool: Serum MicroRNSa (miRNAs) as Translational Biomarkers for DILI
  • Studies in Healthy Volunteers
  • The SAFE-T Consortium

Who Should Attend 

Professionals involved in:

  • Translational Medicine
  • Medical products
  • Regulatory affairs
  • Clinical trials
  • Academic health centers
  • Alternative medicine
  • Natural health products
  • Chemistry, manufacturing & controls
  • Good clinical practices
  • Generic manufacturing
  • Investigative sites
  • Marketing/advertising
  • Nonclinical safety/efficacy/toxicity
  • Over-the-counter drugs
  • Pharmacology
  • Pharmacokinetics/metabolism/pharmacodynamics
  • Medical research
  • Clinical safety/pharmacovigilance
  • Drug development
  • Quality and Compliance

Learning Objectives 


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

  1. Identify the need for new DILI biomarkers.
  2. Discuss the main objectives under investigation in the PSTC hepatotoxicity working group.
  3. Describe  a new and promising tool, serum miRNAs as translational biomarkers for DILI.
  4. Explain the need for continued research and industry-wide archiving of biospecimens from clinical trials in healthy volunteers is necessary in evaluating novel DILI biomarkers.
  5. Discuss the SAFE-T consortium and the DILI biomarker qualification program.

Special Offers 

Series Discount Available!
Register for both webinars in the series and save 10%!

Contact Information 

Agenda and Event Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1-215.442.6199
Colleen.Braun@diahome.org

Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1-215.442.6199
Ellen.Diegel@diahome.org

Registration Questions

Vicki Adkinson, Customer Service Associate
Phone +1.215.442.6162
Fax +1-215.442.6199
Vicki.Adkinson@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 2.00 contact hours or .2 CEUs. Type of Activity: Knowledge UAN: 286-000-12-095-L04-P

ACPE CREDIT REQUEST UPDATE
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.

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 0.2 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.

These programs are part of DIA’s Certificate Program and are awarded the following.
• Regulatory Affairs Certificate Program: 1 Elective Unit each

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

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

Name Credit Type Max Credits CEU
2 Part Series: Drug Induced Liver Injury (DILI) In ACPE 2.00 0.200
2 Part Series: Drug Induced Liver Injury (DILI) In IACET 2.00 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, & complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” & you will be prompted for your user ID & password. Select “My Transcript” (left side bar) & “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, December 19, 2012.

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

Grievance Policy

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Standard
$250.00

Non-Member

NonMember Standard
$295.00
Group Discounts

A Series Discount is Available
Save up to 10% by registering online in one transaction for both webinars in this series. (Special pricing valid for online registrations by individuals and groups. Does not apply to already discounted fees.)

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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