|
Navigate Your Way to Success at the
Largest Life
Sciences Meeting in the Region
We want to make your DIA 2013 49th Annual Meeting experience a breeze.
Navigating through more than 250 educational offerings across 22 tracks can be
overwhelming to select the sessions that best fit your needs. We have provided
a tailored schedule for Clinical Safety and Pharmacovigilance Professionals.
We did the work for you!
What’s more, bring your colleagues or your whole team - divide and
conquer - with so many exceptional sessions, spilt the sessions and
benefit from more at DIA 2013 49th Annual Meeting. Contact our
Group Discount Representative for details!
Don't miss out on this opportunity to meet with people from around the world,
share your views and knowledge, network, and build new relationships with the
greatest educational offerings under one roof.
Lead the Way
to Expedite Products to Market!
Electronic
Health Records (EHRs) in Signal Detection and Evaluation
11:00AM-12:30PM
ET
This session will provide and in-depth update on various initiatives that
have been launched worldwide to investigate the uses of electronic health
records (EHRs).
Narrative
Medicine and Pharmacovigilance
11:00AM-12:30PM ET
In recent years,
pharmacovigilance has emphasized the collection and submission of tabular data.
Using ideas from narrative medicine, we can re-focus on the patient’s story to
better understand adverse drug reactions and Benefit-risk balance.
European
Town Hall: Implementation of New Safety Legislation and Other Hot
Topics
11:00AM-12:30PM ET
Get the first experiences with the new PRAC
and how the PRAC interacts with the different EU committees (such as the CHMP
and CMDh).
The
New Standards for the Identification of Medicinal Products and Individual Case
Safety Reporting Applied in Pharmacovigilance
2:30-4:00PM ET
The
development of the international standards arising from the International
Conference on Harmonization (ICH) are close to finalization and implementation.
Hear about the status of the two related projects from an EMA and FDA
perspective and the industry response to this work.
Characterizing
Drug Shortages and Their Causes: Anticipating Future Trends
2:30-4:00PM
ET
This session includes information on a 2012 study highlighting where and
why drug shortages occur, as well as the impact of other forecasted drug
development and commercialization trends.
Aligning
Statistical Science and Regulatory Practices for Expedited Safety
Reporting
8:00-9:30AM ET
Recommendations are presented from projects
of the CTTI exploring expedited safety reporting for clinical trials, and
aligning regulatory practices for reporting with statistics and patient
expectations.
Social
Media, Mobile Applications and Patient Support Programs: Challenges and
Solutions for Handling Drug Safety Information
8:00-9:30AM ET
Discuss
pharmacovigilance implications including adverse event handling and risk
mitigation solutions from the regulatory and drug safety point of view.
Big
Data: Impact on Innovation
10:15-11:45AM ET
Examine pharma, safety,
and patient perspectives on big data and the need for real-world examples.
EU
Update: PROTECT and EnCePP
10:15-11:45AM ET
Learn about PROTECT, which
aims to develop and validate innovative methods for Benefit-risk assessment of
medicine
Periodic
Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring
and
Benefit-Risk Evaluations
1:45-3:15PM ET
The session will
present the new structure of PSURs/PBRERs according to the GVP/ICH E2C(R2)
guidance. Requirements and challenges will be outlined.
Quality
Assurance for Signal Detection Programs
1:45-3:15PM ET
New EU
legislation requires quality assurance of critical safety processes, including
signal detection. This forum will discuss the best practices for a signal
detection program.
Risk
Management in the US, EU and Japan: The Challenges of
Diversity
4:00-5:30PM ET
This interactive forum will discuss the
differences in legislation and the challenges of risk management planning in the
United States, Europe, and Japan.
Molecular
Predictors of Drug-induced Harm: From Clinical Development to Postmarketing
Surveillance
8:00-9:30AM ET
This session will describe opportunities
to identify molecular predictors of drug-induced harm in clinical development
and postmarketing surveillance.
Pharmacovigilance
Update for Japan, Developing Asia and Latin America
8:00-9:30AM
ET
Review the current status of pharmacovigilance and provide suggestions on
how to meet reporting requirements and working with licensing partners and
affiliated companies in Japan and the developing world in Asia and Latin
America.
An
Interactive Course on Likelihood Ratio Test-based Method for Signal
Detection
1:45-3:15PM ET
This workshop will provide an overview of the
likelihood ratio test-based signal detection method for FDA’s AERS database, as
well as a demonstration of the (LRT) tool.
TransCelerate’s
Collaborative Approach to Risk-based Monitoring: The
Methodology
1:45-3:15PM ET
Learn about the methodology developed by
TransCelerate members for quality risk management and risk-based monitoring
implementation.
Herbal-induced
Organ Toxicity (HILI): How That May Impact Rx Benefit-risk
4:00-5:30PM
ET
Discuss the role of natural health products in risk assessment and the
importance of the internal review process.
Developing
a Patient Aid to Make Information about Treatment Benefits, Harms and
Uncertainties Meaningful to Individual Patients and Enhance Their
Decisions
4:00-5:30PM ET
The session will: 1) raise awareness across
the decision-making health community about recent drug regulatory science
innovations driving a patient-focused approach; and 2) be a springboard to
trigger further engineering of applications for these trends for use across the
community.
Tracking
Misuse and Abuse of Marketed Products: Is Pharma Doing All that It
Can?
9:00-10:30AM ET
This session will focus on the best practices
involved in monitoring, tracking and reporting off-label use and misuse and
abuse of pharmaceutical products.
Coding
with Confidence
9:00-10:30AM ET
You will apply the key principles of
the “MedDRA® Term Selection: Points to Consider” document by engaging in
practical coding exercises in an interactive format.
Off-target
Blood Pressure Changes and Evaluation in Drug Development: Safety,Clinical and
Regulatory Considerations
10:45-12:45AM ET
Gain insight into the
“off-target” BP response of drugs outside of cardiovascular drugs from a
development and regulatory perspective.
| Sunday, June 23
Preconference Tutorials |
Kick off the week by extending your education prior to the start of the
Annual Meeting. Register for two half-day tutorials or one full-day tutorial and
SAVE $100 on of your Annual Meeting registration.
Risk
Communications
9:00AM-5:00PM ET
Analysis
of Safety Data from Clinical Trials
1:00-4:30PM ET
Highlights of the New
Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for
Successful Implementation and Lessons Learned
1:00-4:30PM ET
|
Keynote Speaker |
Hotel &
Travel |
Exhibiting |
 |
 |
 |
Daniel
Kraft, MD
Executive Director, FutureMed |
Book
within the DIA Room Block,
get special perks! |
90% of the hall is SOLD. Reserve
your booth today! |
 |
|
No comments:
Post a Comment