2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle - Part 1: DILI Causality: Are Current Tools and Methods Adequate? The Future of Causality

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 1:

DILI causality assessment is challenging to every company globally for their potential compound in development or product in the market. Should one follow the causality algorithm or expert opinion or the combination? Of the algorithms, which one could be used? Is there a consensus amongst the FDA reviewers and the marketing authorization holder (MAH)? Is there a scope for improvement of the algorithm? If so who will do it? In this webinar you will learn what the Drug Induced Liver Injury Network (DILIN) is, and how the global DILI activities are progressing. Participants may provide feedback to the DILIN group for enhancement in their ongoing efforts. Join us and share your thoughts with the leading global experts in DILI causality assessment. DILI related thoughts and ideas may be emailed in advance of the webinar to DILIwebinar@diahome.org

Featured Topics

Understanding DILI (Drug-Induced Liver Injury)
Minimum Requirements for Drug-Induced Liver Injury Causality Assessment by Regulatory Reviewers
Components of Hy’s Law. Clarification: Useful to all Users
Common Pitfalls and Potential Solutions Industry May Follow

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:

Explain how to better handle DILI causality assessment.
Identify the minimum requirements for Drug-Induced Liver Injury causality assessment by regulatory reviewers.
Describe in detail the components of Hy’s Law and their clarification.
Identify common pitfalls and potential solutions of causality assessment for liver injury.

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

Agenda and Event Details
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

Technical Requirements

Click here for minimum system requirements.

Presenter(s)

Previous Next

Presenter(s) 1-3 of 6

Pradip K. Paul, MD,MS

Consultant
Strategic Pharmacovigilance and Risk Management , United States

Gaby L. Danan, MD,PhD

Hepatologist, Pharmacovigilance Expert
GLD Conseil, France

John R. Senior, MD

Associate Director for Science
FDA, United States

Presenter(s) 4-6 of 6

Leonard B. Seeff, MD

Consultant in Hepatology
The Hill Group, United States

Sif Ormarsdottir, MD,PhD

Chair, Hepatotoxicity Safety Knowledge Group
AstraZeneca, Sweden

Arie Regev, MD

Head, Safety Advisory Hub, Chair Liver & GI Safety Comm, Global Patient Safety
Eli Lilly & Co., United States

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: 286-000-12-094-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 11, 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 Individual: $250.00

Non-Member

NonMember Individual: $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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