Join us for an informative webinar on
MD, DNB
President, Clinical Safety And PV
MD
Sr. Safety Physician, Clinical Safety And PV
We are delighted to invite you for an interactive webinar on “Evaluation of Drug-Induced Liver Injury Risk in Premarketing Clinical Drug Trials” on 16th November 2023. Drug-Induced Liver Injury (DILI) is a rare but potentially fatal adverse drug reaction. It is the most frequent cause of acute liver failure in North America and Europe and is a key reason for the failure of a drug to obtain marketing authorization. The underlying mechanisms are still unclear and hence are difficult to predict during drug development.
Key Discussion Pointers
DILI Categories
Severity of DILI
Signals of DILI and Hy's Law
Open Discussion
DILI Diagnosis and Causality Assessment
eDish for Hepatotoxicity Assessment
Clinical Researchers, Medical Professionals, Pharmaceutical Industry Representatives, Regulatory Agencies, and Academic Researchers. Also designed for experts from Drug Safety, Pharmacovigilance, Risk Management, Benefit-risk Assessment and Communication, Medical Product Safety Assessment, Regulatory Affairs, Clinical Research and Data Safety Monitoring and Analysis
DILI is a key concern for regulators, drug developers, and physicians, and is difficult to predict during the drug development process.
As severe DILI is generally rare, finding a single case may require treatment of thousands of people from varied patient populations.
The clinical trials present an exclusive opportunity to detect hepatotoxicity and cases of potential DILI with a study drug prior to its use in the general population.
Monitoring of standard serum liver tests to detect milder liver injury is the main approach to anticipate a possible DILI risk in clinical trials.
Evaluation of each potential DILI case in clinical trials requires a systematic collection of adequate diagnostic datasets and a rigorous assessment for causality, performed by clinical experts in this area.
This eagerly anticipated topic was featured at WDSC 2023 and is now available for those who missed it. Don’t miss this opportunity!
MD, DNB
President, Clinical Safety & PV
Dr. Sumit Verma is a medical graduate with specialization in anesthesiology and has more than 15 years of experience in the pharmaceutical industry, clinical medicine, clinical research, and pharmacovigilance. He has built teams that have consistently delivered and exceeded customer expectations across pharmacovigilance domains such as case processing, signal management, risk management, aggregate reports, and clinical safety. He has co-authored two books – one on pharmacovigilance and another on pharmacology.
MD
Sr. Safety Physician, Clinical Safety & PV
Dr. Yogesh Gulati is a medical graduate with a specialization in pharmacology and has more than 13 years of experience in the pharmaceutical industry and clinical research. He has led teams that have delivered quality documents across various pharmacovigilance domains including case processing, signal management, risk management, and aggregate reports. He has been involved in the setup of a standalone pharmacovigilance unit and gradual scale-up of operations while ensuring system and regulatory compliance. He has co-authored books on pharmacovigilance, pharmacology, and nursing drug guide.
