Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
Oct 15 2013 7:00AM - Oct 17 2013 3:00PM | Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road,
North Bethesda, MD 20852
Establishing safety of new drug candidates remains a major challenge at every stage of the development process. This conference will explore the current state of the art as well as how our evolving understanding of underlying mechanisms is leading to new strategies for risk assessment and mitigation including the application of novel translational biomarkers and other personalized medicine approaches.
The focus will be on drug toxicity to the liver, heart, kidney and skin. Within each organ system, what is worth doing? What is possible to predict about organ toxicity… before a compound is synthesized? …in non-clinical assessments? …in high-throughput assays? Having identified an important risk, should development be abandoned or can it proceed? Can personalized medicine be applied to risk management? Can patients be protected by monitoring organ function or by assaying new translational biomarkers? Benefit must outweigh risk to patients across the entire product life cycle. Do the strategies used in clinical development translate to the post-marketing setting?
This is the one conference that should be attended by all those with responsibilities in drug safety across the entire life cycle of a drug. In just 2.5 days your team will receive the latest updates on Drug Induced Organ Injury from the US, Europe and Japan.
This program is developed by the DIA Clinical Safety and Pharmacovigilance Community in collaboration with Academia, Regulators and Industry Experts.
Who Should Attend
Professionals with intermediate to advanced knowledge in assessing drug safety during the entire lifecycle of the drug, including:
- Risk identification, characterization, and management
- Non-clinical safety and toxicology
- Overall medical product safety assessment
- Safety signal detection, assessment, and management
- Benefit-risk assessment
- Regulatory affairs
- Clinical research, including Investigators, clinical trial sponsors, statisticians
- Contract Research Organizations (CROs), and others following Good Clinical Practices (GCPs)
- Study design, protocol preparation, and data analysis
- Informed Consent preparation, Institutional Review Board (IRBs) activities, or independent Data Safety Monitoring Boards (DSMBs)
- Medical writing
- Medical product labeling and communication of safety information
- Health outcomes research
- Translational medicine
- Chemistry, Manufacturing & Controls (CMC)
- Pharmacokinetics/ Pharmacodynamics and Adsorption, Distribution, Metabolism, and Excretion (ADME)
- Clinical Quality Assurance and compliance
At the conclusion of this program, participants should be able to:
- Recognize how to better handle cases of drug-induced liver injury, including causality assessment and use of new biomarkers
- Describe the importance of prioritizing drug-induced heart injury
- Discuss drug-induced kidney injury and the use of novel biomarkers for early detection
- Recognize the essential features of drug induced kidney injury
- Discuss population differences and genetic markers of risk for severe drug-induced skin injury and how benefit-risk profiles may differ by population for a given compound
- Discuss essential requirements for assessment of drug-induced organ injuries from a regulatory review perspective
- Identify common pitfalls and potential approaches to causality assessment for drug-induced organ injury.
- Apply a strategy early in the product life cycle for handling possible drug-induced organ injury
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
The conference will be held at the Bethesda North Marriott Hotel and Conference Center.
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until Monday, September 9, 2013, or until room block is filled). Attendees can call +1.212.532.1660 or in the USA at 1.800.221.3531 for reservations. When calling, please select option 1 for “Hotel Reservations," inform the phone agent that it is a DIA event, and provide them with the date and title of the meeting. Please Note: In order to receive the reduced room rate, hotel reservations must be made as noted above and not directly with the hotel.
Standard Room Rate $199
Hotel Address: 5701 Marinelli Road North Bethesda, MD 20852
The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible.
- Member Government Individual
- Member Academia Individual
- Member Industry
- Member Industry (As of 09/25/2013)
- NonMember Government Individual
- NonMember Academia Individual
- NonMember Individual
Printable Registration Form
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.
To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.
Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia
CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
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.
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.