Continuing Education credit or Certificate Program units are not available for Archived Webinars
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.
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.
Archived Webinar Available through December 5, 2013.
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
- Nonclinical safety/efficacy/toxicity
- Over-the-counter drugs
- Medical research
- Clinical safety/pharmacovigilance
- Drug development
- Quality and Compliance
At the conclusion of this webinar, participants should be able to:
- Identify the need for new DILI biomarkers.
- Discuss the main objectives under investigation in the PSTC hepatotoxicity working group.
- Describe a new and promising tool, serum miRNAs as translational biomarkers for DILI.
- 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.
- Discuss the SAFE-T consortium and the DILI biomarker qualification program.
Series Discount Available
Register for both webinars in the series and save 10%!
for minimum system requirements.
- Charitable Nonprofit/Academia Individual
- Government (Full Time) Individual
- Group Plus
- Group Site
- Member Individual
- NonMember Individual
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.